8-K: Cognition Therapeutics Launches Expanded Access Program for Zervimesine in Dementia with Lewy Bodies, Backed by Philanthropic Funding

Cognition Therapeutics, Inc. announced the launch of an expanded access program for its investigational drug zervimesine (CT1812) for patients with dementia with Lewy bodies, substantially funded by an anonymous philanthropic donation.

Summary

• Cognition Therapeutics, Inc. (NASDAQ: CGTX) has initiated an expanded access program (EAP) for zervimesine (CT1812) in patients with dementia with Lewy bodies (DLB).
• The EAP is substantially funded by an anonymous philanthropic donation from the family of a DLB patient who participated in the Phase 2 SHIMMER study.
• Participants in the open-label EAP will receive 100 mg of oral zervimesine daily for approximately one year.
• Dr. James E. Galvin of the University of Miami Miller School of Medicine will serve as the lead investigator for the multi-center EAP.
• Banner Sun Health Research Institute in Arizona, with Dr. David Shprecher as primary investigator, is the first of eight U.S. sites to be activated.
• The program, referred to as COG1202, will initially accommodate approximately 30 individuals, with potential for more patients as funding and drug supply allow.
• Eligible participants include those who completed the Phase 2 SHIMMER study and additional patients with mild-to-moderate DLB meeting program criteria.
• Zervimesine is an investigational medicine not yet approved by regulatory authorities, and its safety and efficacy are not fully characterized.

Sentiment

Score: 8

Explanation: The sentiment is highly positive due to the launch of an Expanded Access Program for a critical neurodegenerative disorder, significantly funded by a philanthropic donation. This provides early patient access and demonstrates external validation and support for the investigational drug, zervimesine. While the drug is still investigational, the EAP is a strong positive step.

Positives

• The launch of an Expanded Access Program (EAP) provides early access to zervimesine for patients with dementia with Lewy bodies (DLB) who have limited treatment options.
• The EAP is substantially funded by an anonymous philanthropic donation, reducing the financial burden on Cognition Therapeutics for this program.
• The involvement of prominent researchers like Dr. James Galvin and Dr. David Shprecher, who were involved in the Phase 2 SHIMMER study, ensures continuity and expertise.
• The rapid onboarding of participating sites aims to begin providing zervimesine to eligible patients within the current month, demonstrating operational efficiency.
• The program allows for potential expansion beyond the initial 30 individuals if additional funding and drug supply become available.

Negatives

• Zervimesine is an investigational medicine and has not been approved by regulatory authorities, meaning its safety and efficacy are not yet fully characterized.
• The EAP is limited to approximately 30 individuals initially, which may not meet the full demand from eligible patients.

Risks

• Uncertainties inherent in the results of preliminary data, pre-clinical studies, and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials.
• The timing, scope, and likelihood of regulatory filings and approvals, including regulatory approval of product candidates, are uncertain.
• The company's ability to secure new (and retain existing) grant funding is not guaranteed.
• Competition from other companies developing treatments for neurodegenerative disorders could impact market share.
• The company's ability to successfully advance current and future product candidates through development activities, preclinical studies, and clinical trials, and the associated costs.
• Changes in applicable laws or regulations could adversely affect the company's operations.
• The company may be adversely affected by other economic, business, or competitive factors, including ongoing economic uncertainty.
• The company's ability to grow and manage growth, maintain relationships with suppliers, and retain management and key employees.
• The company's ability to implement strategic initiatives and continue to innovate existing products.
• The company's ability to defend its intellectual property.
• The impacts of ongoing global and regional conflicts on the company's business, supply chain, and labor force.
• The company's ability to maintain the listing of its common stock on the Nasdaq Global Market.

Future Outlook

Cognition Therapeutics aims to move as rapidly as possible to onboard participating sites and begin providing zervimesine to eligible patients this month. The company continues to investigate zervimesine in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study. They believe zervimesine can regulate impaired pathways through its interaction with the sigma-2 receptor.

Management Comments

• Lisa Ricciardi, President and CEO of Cognition Therapeutics, stated: "At Cognition, our ultimate goal is to create a therapy that changes lives. We are moving as rapidly as possible to onboard participating sites so that we can begin providing zervimesine to eligible patients this month."
• Lisa Ricciardi also expressed: "Throughout the SHIMMER study, we have enjoyed a collaborative relationship with Drs. Galvin and Shprecher and their staffs. Their commitment and that of the Cognition team has been instrumental in launching the EAP so rapidly. Cognition would like to extend our sincere thanks to the benefactor and all stakeholders who made this program a reality."
• Dr. James E. Galvin, lead investigator for the EAP, commented: "As a physician, it’s always rewarding when you are able to offer a medication to a patient that may make a meaningful impact on their health. To have touched the anonymous donor’s life so meaningfully that they felt compelled to support an expanded access program for so many people is humbling and rewarding. This program is a unique opportunity, and one that my colleagues and I are excited to be involved in."

Industry Context

The launch of an Expanded Access Program (EAP) for an investigational drug like zervimesine in dementia with Lewy bodies (DLB) is significant in the neurodegenerative disease space, where treatment options are limited. EAPs provide a pathway for patients with serious or life-threatening conditions to access unapproved therapies when no comparable or satisfactory alternative therapy is available. Philanthropic funding for such programs can accelerate patient access and demonstrate confidence in the investigational therapy, potentially setting a precedent for similar initiatives in areas of high unmet medical need.

Comparison to Industry Standards

• NA

Stakeholder Impact

• **Shareholders:** Positive news regarding the advancement of a key pipeline candidate and external funding for an EAP could enhance investor confidence and potentially impact share price positively.
• **Patients and Caregivers:** Provides early access to an investigational treatment for a severe neurodegenerative disorder (DLB) where treatment options are limited, offering hope and potential therapeutic benefit.
• **Employees:** Reinforces the company's mission and commitment to developing therapies for neurodegenerative disorders, potentially boosting morale and engagement.
• **Philanthropic Donor:** The donation directly enables patient access to the investigational drug, fulfilling the donor's intent to support the DLB community.
• **Medical Community:** The EAP, led by prominent investigators, contributes to real-world data collection for zervimesine in a clinical setting, potentially informing future research and understanding of DLB.

Next Steps

• Onboarding of additional participating sites for the Expanded Access Program (EAP).
• Beginning to provide zervimesine to eligible patients in the EAP this month.
• Potential expansion of the EAP to accommodate additional patients as funding and drug supply allow.
• Continued investigation of zervimesine in clinical programs for dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656).

Key Dates

Recommendation

Keywords

Cognition Therapeutics, zervimesine, CT1812, dementia with Lewy bodies, DLB, expanded access program, EAP, neurodegenerative disorders, clinical-stage biopharmaceutical, sigma-2 receptor, Alzheimer's disease, SHIMMER study, clinical trials