Cognition Therapeutics Announces Publication of Commercial Manufacturing Process for Lead Alzheimer’s Candidate, Zervimesine (CT1812)

Rhea-AI Summary

Cognition Therapeutics (NASDAQ: CGTX) has published details of a new manufacturing process for their lead Alzheimer's candidate, zervimesine (CT1812), in the American Chemical Society journal Organic Process Research & Development. The company has filed provisional patent applications for both the chemical process and a preferred polymorphic form of the drug.

The new manufacturing process incorporates high throughput screening and light-induced, continuous flow processing technologies, enabling more efficient and safer synthesis of zervimesine. Notably, researchers have identified a novel crystal form of the drug with enhanced room temperature stability, promising a longer shelf life and improved pharmaceutical properties. This process is expected to support both future clinical studies and potential commercial manufacturing needs if the drug receives approval.

Positive

• Patent applications filed for new manufacturing process and polymorphic form
• Improved drug stability at room temperature
• Enhanced manufacturing efficiency and safety
• Process capable of supporting both clinical and commercial production

Negative

• None.

Insights

Manufacturing Process Development Expert

The publication in the American Chemical Society journal represents a important advancement in Cognition Therapeutics' commercialization strategy for zervimesine. The development of an optimized manufacturing process incorporating high-throughput screening and continuous flow processing technologies typically translates into significant cost efficiencies and improved batch-to-batch consistency - critical factors for commercial-scale production.

The discovery of a novel polymorph with enhanced room temperature stability is particularly significant from a commercial perspective. This characteristic can substantially reduce storage and transportation costs, as specialized temperature-controlled facilities and shipping methods may not be required. The improved stability profile also typically extends shelf life, which can enhance the product's commercial viability and reduce waste from expired inventory.

The filing of provisional patents for both the manufacturing process and the novel polymorph creates multiple layers of intellectual property protection. This strengthened IP position not only protects the company's commercial interests but also potentially increases its attractiveness to potential partners or acquirers. The timing of these developments, ahead of later-stage clinical trials, positions the company favorably for potential commercialization, as manufacturing scalability and stability are often critical considerations for regulatory approval.

From a risk management perspective, having a well-defined, efficient manufacturing process at this stage helps derisk the development pathway. The publication in a peer-reviewed journal also provides third-party validation of the technical achievements, which can be valuable for investor confidence and potential partnership discussions.

- Chemical process enhances room temperature stability -

- Provisional patent applications filed -

PURCHASE, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today announced that the American Chemical Society journal Organic Process Research & Development has published a manuscript describing the novel chemical process used to manufacture zervimesine (CT1812). With this new manufacturing process, Cognition will be able to produce materials for future clinical studies of zervimesine. In addition, if zervimesine is approved, this process is expected to support commercial manufacturing needs. Provisional patent applications covering this chemical process and a preferred polymorphic form of zervimesine have been filed.

“The chemical process described in this manuscript leverages innovative technologies such as high throughput screening and light-induced, continuous flow processing to more efficiently and safely synthesize zervimesine,” explained Steven A. Weissman, Ph.D., head of CMC at Cognition Therapeutics. “We have also identified a novel crystal form, or polymorph, of zervimesine that has improved stability at room temperature, enabling a long shelf life, as well as other beneficial pharmaceutical properties. Polymorphs contain the same molecular components as the parent compound but are arranged in a different configuration.”

About Zervimesine (CT1812)
Zervimesine (CT1812) is an investigational oral, once-daily pill being developed for the treatment of central nervous system (CNS) diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain toxic proteins in the brain – amyloid beta (Aβ) and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person’s ability to learn, recall memories, move efficiently, and communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer’s and DLB.

About Cognition Therapeutics, Inc. 
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the CNS. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer’s disease, including the ongoing START study (NCT05531656) in early Alzheimer’s disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and our expectations regarding its manufacturing process and our ability to manufacture sufficient material for the next clinical studies and for commercial manufacture, if approved, and statements regarding our expectations for our patent applications and our intellectual property portfolio are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; 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 our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact Information:    Cognition Therapeutics, Inc.     info@cogrx.com

Casey McDonald (media)   Tiberend Strategic Advisors, Inc.      cmcdonald@tiberend.com

Mike Moyer (investors)  LifeSci Advisors  mmoyer@lifesciadvisors.com

This press release was published by a CLEAR® Verified individual.

FAQ

What is the new manufacturing breakthrough for Cognition Therapeutics' (CGTX) zervimesine?

Cognition Therapeutics has developed a new chemical process using high throughput screening and light-induced continuous flow processing, resulting in more efficient and safer synthesis of zervimesine, along with improved room temperature stability.

How does the new polymorphic form of zervimesine benefit CGTX's drug development?

The new crystal form (polymorph) of zervimesine provides improved stability at room temperature, enabling a longer shelf life and offering beneficial pharmaceutical properties.

What patent protection has CGTX secured for zervimesine's manufacturing process?

Cognition Therapeutics has filed provisional patent applications covering both the new chemical process and the preferred polymorphic form of zervimesine.

Will CGTX's new manufacturing process support commercial production of zervimesine?

Yes, the new process is designed to support both future clinical studies and commercial manufacturing needs if zervimesine receives regulatory approval.