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GRI Bio Presents Positive Pre-Clinical Data Demonstrating GRI-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis and Reiterates Promising Preliminary Phase 2a Clinical Results
Globenewswire· 2025-05-22 12:00
Core Insights - GRI Bio, Inc. presented positive preclinical data at the 2025 ATS International Conference, indicating that GRI-0621 has potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis [1][2][3] - The ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) is expected to provide interim analysis results in Q2 2025 [1][3] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][10] - The lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity and is currently in a 12-week, double-blind, randomized, placebo-controlled study for IPF [6][10] Clinical Study Details - The Phase 2a study aims to assess the safety and tolerability of GRI-0621, along with its effects on various biomarkers associated with disease progression [6][7] - Interim results from the first 12 patients indicated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels [7][9] Research Findings - The presented data included biochemical, qPCR, and immunohistochemistry analyses, demonstrating that iNKT cell inactivation during the fibrotic phase can significantly inhibit fibroblast activation and fibrosis in a murine model [4][8] - GRI-0621 showed therapeutic effects in reducing lung injury and impacting key cellular and molecular drivers of lung disease, performing comparably or better than the approved drug nintedanib [8][9] Future Expectations - The interim analysis committee has recommended the continuation of the Phase 2a study, with topline results expected in Q3 2025 [9]
GRI Bio (GRI) 2025 Conference Transcript
2025-05-21 19:40
Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of invariant natural killer T (NKT) cells [2][5] Core Program - **Lead Program**: GRI o six two one (GRI621) - **Type**: Small molecule inhibitor of type one invariant NKT cells - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][17] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - Inhibition of NKT cells shown to be therapeutic across various preclinical models of fibrosis [8][9] - Increased NKT cell activity correlates with worsening fibrotic disease, suggesting potential as a biomarker [9][12] Clinical Trial Details - **Trial Design**: - 36 patients, randomized 2:1 (GRI621 vs. placebo) - Duration: 12 weeks, with patients allowed to continue background therapy [18][19] - Primary endpoints: Safety, tolerability, pharmacokinetics, biomarkers of fibrosis, and pulmonary function tests [19][25] - **Enrollment Status**: Approximately 80% enrolled [20] Interim Results - **Recent Findings**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) for continued trial [24] - **Early Data**: Indication of antifibrotic signal observed in initial 12 patients after two weeks [24] Challenges in IPF Treatment - **Current Landscape**: - Existing treatments (nantenadib and profinidone) slow lung function decline but do not improve overall survival [32] - Significant side effects limit patient compliance [32] - **Focus on Upstream Targets**: GRI Bio aims to address earlier stages in the inflammatory cascade rather than late-stage targets like TGF beta [33][34] Market Potential - **Market Size**: IPF is an orphan indication; nantenadib generated approximately $4 billion in sales last year [38] - **Competitive Landscape**: Other drugs in development face challenges, including drug-drug interactions and tolerability issues [39][40] Future Considerations - **Regulatory Pathways**: Potential for expedited approval due to existing safety data from other indications [47] - **Pipeline Opportunities**: GRI Bio is developing additional programs, including GRI o eight zero three (GRI803) targeting systemic lupus erythematosus [49][50] Conclusion - GRI Bio is positioned to address significant unmet needs in the treatment of IPF through innovative targeting of NKT cells, with ongoing clinical trials and a robust pipeline of future therapies [52]
GRI Bio (GRI) Conference Transcript
2025-05-21 19:40
Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of NKT cells [2][5] Lead Program - **Product**: GRI o six two one - **Type**: Type one invariant natural killer T cell antagonist - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][18] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - **Therapeutic Approach**: Inhibiting NKT cell activity to interrupt disease progression and restore immune homeostasis [5][8] - **Biomarker Potential**: Increased NKT cells correlate with worsening fibrotic disease, suggesting their role as a useful biomarker [9][39] Clinical Trial Details - **Trial Design**: - 36 patients, 2:1 randomization (24 on GRI o six two one, 12 on placebo) - Duration: 12 weeks, with primary endpoints focusing on safety and tolerability [16][18] - **Enrollment Status**: Approximately 80% enrolled, with interim data expected in Q2 2025 [18][22] Data and Results - **Interim Analysis**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) after 12 patients completed two weeks [21] - **Early Signals**: Antifibrotic signal observed in pro-collagen type III (pro C3) after two weeks [21][26] Market Context - **Market Size**: IPF is an orphan indication; Nintanadib, one of the approved drugs, generated approximately $4 billion in sales last year [35] - **Challenges**: Current treatments slow disease progression but do not improve overall survival; significant side effects limit patient compliance [29][30] Competitive Landscape - **Current Treatments**: Nintanadib and Perfinetone are the two approved drugs, both with limitations in efficacy and tolerability [35][36] - **Future Positioning**: GRI o six two one aims to address the disease earlier in the inflammatory cascade compared to existing therapies [30][31] Regulatory Considerations - **Expedited Approval**: Potential for a single registration trial due to existing safety data from other indications [43][44] Pipeline Opportunities - **Future Programs**: GRI o eight zero three targeting type two NKT cells for systemic lupus erythematosus; additional 500 compounds in the library for future development [46][47] Conclusion - GRI Bio is positioned to potentially disrupt the IPF treatment landscape with GRI o six two one, focusing on early intervention in the inflammatory process and leveraging NKT cells as biomarkers for disease progression [5][39]
GRI Bio to Participate in the Virtual Investor Closing Bell Series
Globenewswire· 2025-05-21 13:15
Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [4] - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as a novel oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [4] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [4] Upcoming Event - Marc Hertz, PhD, CEO of GRI Bio, will participate in the Virtual Investor Closing Bell Series on May 28, 2025, at 4:00 PM ET, providing a corporate overview and business outlook [1][2] - The event will allow investors and interested parties to submit questions live, with the company aiming to answer as many as possible within the time allowed [2] Webcast Information - A live video webcast of the event will be available on the company's website, with a replay accessible for 90 days following the live event [3]
GRI Bio to Present at A.G.P.'s Annual Healthcare Company Showcase
Globenewswire· 2025-05-16 13:15
Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [3] - The company's lead program, GRI-0621, is an oral therapeutic aimed at inhibiting iNKT cell activity for the treatment of idiopathic pulmonary fibrosis, addressing a significant unmet medical need [3] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus, supported by a library of over 500 proprietary compounds [3] Event Participation - Marc Hertz, PhD, CEO of GRI Bio, will participate in a fireside chat at A.G.P.'s Annual Healthcare Company Showcase on May 21, 2025, at 2:40 PM ET [1] - The event will be accessible via a live webcast on the company's website [2]
GRI Bio(GRI) - 2025 Q1 - Quarterly Report
2025-05-15 12:38
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's Q1 2025 financial statements show decreased cash and assets, increased liabilities, a higher net loss, and subsequent capital raising [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's cash, total assets, and stockholders' equity decreased, while total liabilities increased Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,281 | $5,028 | | Total current assets | $3,930 | $5,615 | | Total assets | $4,042 | $5,739 | | **Liabilities & Equity** | | | | Total current liabilities | $2,779 | $1,636 | | Total liabilities | $2,837 | $1,707 | | Total stockholders' equity | $1,205 | $4,032 | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For Q1 2025, the company reported a net loss of $3.0 million, up from $1.9 million in Q1 2024, driven by increased operating expenses Quarterly Operating Results (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,640 | $933 | | General and administrative | $1,411 | $962 | | **Total operating expenses** | **$3,051** | **$1,895** | | **Loss from operations** | **($3,051)** | **($1,895)** | | **Net loss** | **($3,046)** | **($1,887)** | | Net loss per share, basic and diluted | ($5.80) | ($101.05) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operations decreased, but financing activities shifted to usage, leading to a net cash decrease Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Cash used in operating activities | ($1,736) | ($2,203) | | Cash (used in) provided by financing activities | ($11) | $4,486 | | **Net (decrease) increase in cash** | **($1,747)** | **$2,283** | | Cash and cash equivalents at end of period | $3,281 | $4,091 | [Notes to Unaudited Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, significant going concern doubt, and recent financing activities including an April 2025 public offering - The company is a clinical-stage biopharmaceutical firm developing therapies for inflammatory, fibrotic, and autoimmune disorders. Its lead product, **GRI-0621**, targets idiopathic pulmonary fibrosis (**IPF**), while **GRI-0803** targets autoimmune disorders like **lupus** and **MS**[21](index=21&type=chunk) - There is **substantial doubt** about the company's ability to continue as a **going concern**. Existing cash of **$3.3 million** (as of March 31, 2025) is projected to fund operations only through the **third quarter of 2025**, necessitating additional capital raising[23](index=23&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - In **April 2025**, the company executed a **public offering**, raising gross proceeds of **$5.0 million** through the sale of common stock, pre-funded warrants, and several series of common stock warrants[65](index=65&type=chunk) - The company has engaged in multiple financing activities, including a **February 2024 offering** (net proceeds **$4.4M**), a **May 2024 At-The-Market (ATM) offering** (gross proceeds **$3.6M** as of Q1 2025), a **June 2024 offering** (net proceeds **$3.2M**), and an **October 2024 warrant repricing**[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses GRI-0621 development, increased Q1 2025 net loss from higher expenses, and critical funding needs due to going concern doubt [Overview and Recent Developments](index=19&type=section&id=Overview%20and%20Recent%20Developments) The company is advancing GRI-0621 for IPF, with GRI-0803 on hold; recent developments include a reverse stock split and a $5.0 million capital raise - The company is advancing its lead product, **GRI-0621**, in a **Phase 2a study** for **IPF**, with interim data anticipated in **Q2 2025** and topline results in **Q3 2025**[72](index=72&type=chunk) - Development of the second product candidate, **GRI-0803** for **lupus** and **MS**, is **on hold** pending additional funding, with plans to file an **IND in 2025** if capital is secured[73](index=73&type=chunk) - A **1-for-17 reverse stock split** was effected in **February 2025**, and the company regained **Nasdaq compliance** in **March 2025**[74](index=74&type=chunk)[79](index=79&type=chunk) - In **April 2025**, the company entered into a securities purchase agreement for gross proceeds of **$5.0 million**[75](index=75&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 saw R&D expenses increase by $0.7 million and G&A expenses by $0.4 million, leading to a higher net loss of $3.0 million Comparison of Operating Results (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,640 | $933 | +$707 | | General and administrative | $1,411 | $962 | +$449 | | **Net loss** | **($3,046)** | **($1,887)** | +($1,159) | - The **$0.7 million increase** in **R&D expenses** was mainly due to increased costs for the **GRI-0621** registration development program[87](index=87&type=chunk) - The **$0.4 million increase** in **G&A expenses** was primarily due to a **$0.3 million rise** in **personnel expenses** (including stock compensation) and a **$0.2 million increase** in **professional fees**[88](index=88&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges with limited cash, an accumulated deficit, and a critical need for additional funding, raising substantial doubt about its going concern ability - The company had **$3.3 million** in cash and an accumulated deficit of **$42.8 million** as of March 31, 2025[91](index=91&type=chunk)[97](index=97&type=chunk) - Existing cash and cash equivalents are expected to fund operating expenses and capital requirements only through the **third quarter of 2025**[98](index=98&type=chunk) - The company will need to obtain **substantial additional funding** to continue operations. Failure to secure financing may force it to **delay or discontinue development programs or cease operations entirely**[99](index=99&type=chunk)[100](index=100&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in Operating activities | ($1,736) | ($2,203) | | Net cash (used in) provided by Financing activities | ($11) | $4,486 | [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not applicable as the company qualifies as a smaller reporting company - Disclosure is **not required** as the company is a **smaller reporting company**[105](index=105&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective due to a material weakness in accounting for a warrant repricing, with a remediation plan underway - Management concluded that disclosure controls and procedures were **not effective** as of March 31, 2025[108](index=108&type=chunk) - A **material weakness** was identified related to the **inaccurate accounting** for a **warrant repricing transaction**, specifically the computation of the **non-cash deemed dividend**[109](index=109&type=chunk) - A **remediation plan** has been implemented, involving the engagement of **third-party experts** and **refinement of internal communication and documentation processes** for complex transactions[110](index=110&type=chunk)[112](index=112&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened actions - The company is **not currently involved** in any **material legal proceedings**[115](index=115&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - **No material changes** from the risk factors disclosed in the Annual Report[116](index=116&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or issuer purchases were reported during the period - **None reported**[117](index=117&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - **No directors or officers** adopted or terminated **Rule 10b5-1 trading arrangements** during the quarter[120](index=120&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and documents incorporated by reference
GRI Bio(GRI) - 2025 Q1 - Quarterly Results
2025-05-15 12:35
[GRI Bio First Quarter 2025 Financial Results and Corporate Update](index=1&type=section&id=GRI%20Bio%20First%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Update) [Corporate and Clinical Highlights](index=1&type=section&id=Recent%20Highlights) GRI Bio reported positive interim Phase 2a data for GRI-0621 in IPF, strengthened intellectual property, and extended its cash runway with a $5.0 million public offering - Reported **positive interim 2-week safety and biomarker results** from the ongoing Phase 2a study of GRI-0621 for IPF[1](index=1&type=chunk)[3](index=3&type=chunk)[5](index=5&type=chunk) - **Completed patient enrollment for the 6-week interim analysis (n=24)** and has enrolled over two-thirds of the total trial participants[1](index=1&type=chunk)[5](index=5&type=chunk) - **Strengthened its global intellectual property portfolio** with the granting of patents in Europe and Japan[5](index=5&type=chunk) - Closed a **$5.0 million public offering**, extending the company's cash runway[5](index=5&type=chunk)[11](index=11&type=chunk) [Clinical Program Update: GRI-0621 for IPF](index=1&type=section&id=Clinical%20Program%20Update) The Phase 2a study of GRI-0621 for IPF demonstrated safety and tolerability in early patients, with interim biomarker data suggesting an anti-fibrotic effect - GRI-0621 is a **small molecule RAR-βɣ dual agonist** designed to inhibit iNKT cell activity for treating IPF, a chronic progressive pulmonary disease with limited treatment options[5](index=5&type=chunk)[6](index=6&type=chunk) - A pre-planned interim analysis of the first 12 patients showed GRI-0621 (4.5mg orally once daily) to be **safe and well-tolerated**, with **no hyperlipidemia** observed at the 2-week visit[7](index=7&type=chunk) - Interim biomarker results from the first 12 subjects showed a change from baseline in PRO-C3 that is **suggestive of an anti-fibrotic effect**, leading the IDMC to recommend the study continue as planned[8](index=8&type=chunk) [Upcoming Milestones](index=2&type=section&id=Expected%20GRI-0621%20Upcoming%20Milestones) GRI Bio anticipates reporting significant data from its Phase 2a trial of GRI-0621 in the second and third quarters of 2025, marking key catalysts for the program - **Q2 2025**: Report **6-week interim results** from the Phase 2a biomarker study[11](index=11&type=chunk) - **Q3 2025**: Report **topline results** from the Phase 2a biomarker study[9](index=9&type=chunk)[11](index=11&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=Summary%20of%20Financial%20Results%20for%20First%20Quarter%202025) GRI Bio reported a **$3.0 million net loss** for Q1 2025, with increased R&D and G&A expenses, and an extended cash runway through Q3 2025 after a **$5.0 million public offering** Key Financial Metrics | Financial Metric | Q1 2025 | | :--- | :--- | | Net Loss | $3.0 million | | Cash and Cash Equivalents (as of Mar 31) | $3.3 million | Operating Expenses | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research & Development | $1.6 million | $0.9 million | | General & Administrative | $1.4 million | $1.0 million | - The company's existing cash, supplemented by a subsequent **$5.0 million public offering**, is expected to fund operations and capital expenditures through **Q3 2025**[1](index=1&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Company Overview](index=3&type=section&id=About%20GRI%20Bio%2C%20Inc.) GRI Bio is a clinical-stage biopharmaceutical company developing NKT cell-targeted therapies for inflammatory, fibrotic, and autoimmune diseases, with lead program GRI-0621 for IPF - GRI Bio is a **clinical-stage biopharmaceutical company** focused on modulating **Natural Killer T (NKT) cells** to treat inflammatory, fibrotic, and autoimmune diseases[2](index=2&type=chunk)[13](index=13&type=chunk) - The lead program, **GRI-0621**, is an **oral inhibitor** of type 1 invariant NKT (iNKT) cell activity being developed for **Idiopathic Pulmonary Fibrosis (IPF)**[13](index=13&type=chunk) - The company's pipeline also includes **novel type 2 diverse NKT (dNKT) agonists** for **systemic lupus erythematosus** and is supported by a **proprietary library of over 500 compounds**[13](index=13&type=chunk)
GRI Bio Reports First Quarter 2025 Financial Results and Confirms GRI-0621 Phase 2a IPF Trial on Track for 6-Week Interim Data in Q2 2025 and Topline Data in Q3 2025
Globenewswire· 2025-05-15 12:35
Core Insights - GRI Bio, Inc. reported positive interim results from its ongoing Phase 2a study of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), indicating safety and potential anti-fibrotic effects [1][2][8] - The company has completed patient enrollment for the 6-week interim analysis with 24 patients and has over two-thirds of enrollment completed for the overall trial [1][8] - GRI Bio's cash runway is expected to fund operations through Q3 2025, bolstered by a recent public offering that raised $5 million [11] Clinical Program Update - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [5][12] - The interim analysis demonstrated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels among the first 12 patients evaluated [6][7] - The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2a study based on the observed safety and biomarker data [7][8] Financial Results - For Q1 2025, GRI Bio reported a net loss of $3 million, with research and development expenses of $1.6 million and general and administrative expenses of $1.4 million [10] - As of March 31, 2025, the company had approximately $3.3 million in cash and cash equivalents, which, along with the recent public offering, is expected to support operations through Q3 2025 [11] Upcoming Milestones - Topline results from the Phase 2a biomarker study are anticipated in Q3 2025, with a 6-week interim results report expected in Q2 2025 [9][14]
GRI Bio's Interim Biomarker Data Demonstrate Positive Trend Towards Anti-Fibrotic Effect of GRI-0621 in First Twelve Patients of Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)
GlobeNewswire News Room· 2025-05-08 12:45
Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 2a study for GRI-0621, indicating no safety concerns in the reviewed data [1][2][4] - GRI Bio has completed patient enrollment for the 6-week interim analysis with 24 subjects and has over two-thirds of the total enrollment completed for the overall trial [1][3] - Interim biomarker results suggest an anti-fibrotic effect of GRI-0621 compared to placebo, with topline data expected in Q3 2025 [2][5] Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis (IPF), a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3] - The primary endpoint is the safety and tolerability of GRI-0621 after 12 weeks, with secondary endpoints including changes in serum biomarkers and pharmacokinetics [3][4] Interim Analysis Findings - The interim analysis showed that GRI-0621 was safe and well-tolerated in the first 12 patients, with no significant changes in lipid levels [4] - The IDMC's recommendation to continue the study is based on the absence of safety concerns and the encouraging trend in anti-fibrotic effects observed [2][4]
GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)
Globenewswire· 2025-05-07 13:15
Core Insights - GRI Bio, Inc. has completed enrollment for a Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), with 24 out of 36 planned patients enrolled [1][2] - The company is on track to report interim biomarker data from the first 12 patients imminently, with topline results expected in Q3 2025 [1][4] - The Phase 2a study is designed as a randomized, double-blind, placebo-controlled trial, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [2][3] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through Natural Killer T (NKT) cell modulators [5][6] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity, aimed at addressing the significant unmet need in IPF treatment [6] Study Details - The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 or placebo [2] - Primary endpoints include safety and tolerability, while secondary endpoints focus on changes in serum biomarkers and pharmacokinetics [2][3] - An interim analysis will be conducted after 24 subjects complete 6 weeks of treatment, with safety results from the first 12 patients showing no significant adverse effects [3]