Cardiol Therapeutics Nominates Dr. Timothy Garnett to Its Board of Directors April 29, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc. Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of th ...

Vivoryon Therapeutics N.V. Reports Full Year 2024 Financial Results and Provides Business Update Successful strategic shift towards a focus on inflammatory and fibrotic diseases, in particular on kidney diseaseVaroglutamstat Phase 2 program shows highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studiesStatistical evidence from meta-analysis of VIVIAD and VIVA-MIND enables ...

Core Insights - BioVie Inc. has initiated patient enrollment for the Phase 2 SUNRISE-PD clinical trial, which evaluates the safety and efficacy of bezisterim in patients with Parkinson's disease who have not been treated with carbidopa/levodopa, with topline data expected in late 2024 or early 2025 [2][4][7] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and long COVID [14][15] - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer and anti-inflammatory drug candidate that may provide clinical improvements in various disease indications [11][14] Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study designed to last 20 weeks, with approximately 60 patients randomized to receive either 20 mg of bezisterim or placebo twice daily [4][5] - The trial incorporates a decentralized approach, allowing patients to participate remotely, which broadens access for individuals with Parkinson's disease [4][6][7] Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms, with current treatments primarily providing symptomatic relief without modifying disease progression [3][8][9] - Emerging research indicates that chronic inflammation and insulin resistance play critical roles in the onset and progression of Parkinson's disease, suggesting that targeting these mechanisms may offer new therapeutic avenues [10][12] Support and Collaboration - Patient enrollment for the SUNRISE-PD trial is supported by prominent advocacy groups, including The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson's Foundation, emphasizing the importance of increased patient access to clinical trials [2][7][6]

Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent PericarditisApril 16, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago.Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Ap ...

Core Insights - Santhera Pharmaceuticals has made significant progress in the commercial rollout of AGAMREE® for the treatment of Duchenne Muscular Dystrophy (DMD), with funding from NHS England now available for prescribing in England [1][2] - AGAMREE has received positive final guidance from NICE, and initial sales have already been achieved in Scotland and Wales [1][2] - Kye Pharmaceuticals, a sub-licensee of Catalyst Pharmaceuticals, has received acceptance from Health Canada for AGAMREE's New Drug Submission with Priority Review, potentially leading to its approval as the first treatment for DMD in Canada by the end of 2025 [2] Product Overview - AGAMREE (vamorolone) is a novel drug that binds to the same receptor as glucocorticoids but modifies its downstream activity, positioning it as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids [3][7] - The pivotal VISION-DMD study demonstrated that AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks, with a good safety and tolerability profile [4][5] - Unlike corticosteroids, AGAMREE shows no restriction of growth and has no negative effects on bone metabolism, as indicated by normal serum markers for bone formation and resorption [5] Company Background - Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare neuromuscular diseases with high unmet medical needs [7] - The company holds an exclusive license for AGAMREE for all indications worldwide and has out-licensed rights for North America to Catalyst Pharmaceuticals and for China and certain Southeast Asian countries to Sperogenix Therapeutics [7][9]

Partnership bolsters Boehringer's autoimmune and inflammatory disease pipeline portfolio aiming to tackle areas of high unmet patient need.The agreement focuses on further research and development of a novel, first-in-class bispecific compound for T cell mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases.The candidate compound has the potential to reach patients with autoimmune diseases earlier in their treatment journey and achieve long-term disease control by r ...

Seres Therapeutics, Inc. (NASDAQ:MCRB) Q4 2024 Earnings Conference Call March 13, 2025 8:30 AM ET Company Participants Carlo Tanzi - Kendall Investor Relations Eric Shaff - President and Chief Executive Officer Lisa von Moltke - Executive Vice President and Chief Medical Officer Matthew Henn - Executive Vice President and Chief Scientific Officer Terri Young - Executive Vice President, Chief Commercial and Strategy Officer Marella Thorell - Executive Vice President and Chief Financial Officer Chris McChalic ...

Core Viewpoint - COSCIENS Biopharma Inc. has initiated its Phase 2a clinical efficacy study for its avenanthramides product, aimed at managing inflammation-related conditions, following a successful Phase 1 trial that demonstrated a favorable safety profile [1][4][5]. Group 1: Clinical Study Details - The Phase 1-2a clinical trial, named the AvenActive study, began in November 2023 and involved 72 healthy subjects, with no significant adverse events reported [3][8]. - The Phase 2a study will enroll 20 patients with mild to moderate inflammation, testing doses of 480 mg and 960 mg per day [4][5]. - Initial dosing for the Phase 2a study is expected to occur on March 14, 2025, at the Montreal Heart Institute [4][8]. Group 2: Product Information - Avenanthramides are di-phenolic compounds found in oats, known for their antioxidant and anti-inflammatory properties [2]. - The study will assess inflammatory biomarkers in blood, focusing on cytokines, chemokines, and high-sensitivity C-reactive protein [5]. Group 3: Company Strategy and Market Potential - The successful completion of the Phase 1 study is viewed as a critical milestone, positioning the company for potential out-licensing and commercialization opportunities [6]. - The company aims to become a global leader in natural-based health and wellness products, with avenanthramides seen as a transformative product [6][10].