Workflow
Breakthrough therapy designation
icon
Search documents
Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB)
Globenewswire· 2025-06-25 11:30
Core Insights - Cognition Therapeutics, Inc. is advancing zervimesine (CT1812) into a Phase 3 program for mild-to-moderate Alzheimer's disease and has filed for breakthrough therapy designation for dementia with Lewy bodies (DLB) [1][2] Group 1: Clinical Development - An end-of-Phase 2 meeting with the FDA is scheduled for July 9, 2025, to discuss the Phase 2 'SHINE' study results and plans for a Phase 3 program for zervimesine in Alzheimer's disease [1] - The company is also progressing with an expanded access program for zervimesine in DLB, which has garnered high interest from former SHIMMER study participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating neurodegenerative diseases, specifically Alzheimer's disease and DLB, by potentially interrupting the toxic effects of protein buildup in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] Group 3: Company Overview - Cognition Therapeutics, Inc. focuses on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and has completed Phase 2 studies for zervimesine in multiple conditions [6]
Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer's Disease and Dementia with Lewy Bodies (DLB)
GlobeNewswire News Room· 2025-06-25 11:30
Core Viewpoint - Cognition Therapeutics, Inc. is advancing its investigational drug zervimesine (CT1812) for the treatment of mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB), with an end-of-Phase 2 meeting scheduled with the FDA to discuss Phase 2 study results and plans for a Phase 3 program [1][2][8] Group 1: Clinical Development - The company will hold an end-of-Phase 2 meeting with the FDA on July 9, 2025, to review the Phase 2 'SHINE' study results of zervimesine in Alzheimer's disease [1] - Cognition is also moving forward with plans for a registrational program for DLB based on positive results from the Phase 2 'SHIMMER' study [2] - An expanded access program for zervimesine in DLB is underway, with high interest from former SHIMMER participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an oral, once-daily investigational drug targeting neurodegenerative diseases, specifically Alzheimer's and DLB, by potentially interrupting the toxic effects of harmful proteins in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] - The USAN Council has adopted zervimesine as the official name for CT1812 [5] Group 3: Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in multiple conditions, including DLB and Alzheimer's disease, and is currently conducting an ongoing Phase 2 study in early Alzheimer's disease [6]
Merus (MRUS) 2025 Conference Transcript
2025-06-04 20:12
Summary of Merus Conference Call Company Overview - **Company**: Merus - **Industry**: Biotechnology, specifically focused on developing bispecific and multispecific antibodies for cancer treatment - **Key Product**: Pedosemtamab, a bispecific antibody targeting EGFR and LGR5 in head and neck cancer [3][7][10] Core Points and Arguments - **Technology Platform**: Merus utilizes a foundational platform technology to develop fully human IgG1 antibodies, which enhances the chances of success in drug development by relying on established methods [4][5] - **Clinical Success**: - Pedosemtamab has shown unprecedented efficacy in head and neck cancer, with a response rate of 63% when combined with Keytruda, significantly higher than the typical 20% response rate seen with standard immunotherapy [10] - One-year overall survival rate for patients treated with pedosemtamab is reported at 79%, with projections suggesting a median overall survival of over 30 months [20][22] - **Regulatory Designation**: Pedosemtamab has received breakthrough therapy designation from the FDA for both single-agent and combination therapy settings, indicating its potential to provide substantial benefits over existing therapies [11][12] - **Phase III Trials**: Enrollment for ongoing Phase III trials is progressing well, with over 125 sites activated. The company anticipates substantial enrollment by year-end and potential top-line results next year [32][33][46] Important but Overlooked Content - **Patient Population Insights**: The Phase II population is considered representative of the overall population, with no strong correlation observed between EGFR expression levels and response rates [16][13] - **Colorectal Cancer Development**: Merus is also exploring pedosemtamab in colorectal cancer, with ongoing cohorts aimed at assessing its efficacy in combination with chemotherapy and as a monotherapy [47][48] - **Financial Position**: As of the last quarter, Merus reported a cash balance of $638 million, bolstered by a recent financing of $300 million, which supports its ongoing clinical trials [63] Key Events to Watch - **Upcoming Data Releases**: Investors should look forward to the initial clinical update on colorectal cancer later this year and the top-line readout from the Phase III trials next year [63]