Cognition Therapeutics獲FDA同意Zervimesine治療DLB精神病關鍵第三期試驗設計

EX-99.1
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EXHIBIT 99.1

 

 

Exhibit 99.1

 

 

 

Cognition Therapeutics Aligns on Key Aspects
of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes 

 

- Zervimesine Would be the First Long-term,
Durable Treatment Option with an Impact on Underlying Disease -

- Company Developing NPI as a Measure of DLB
Psychosis -

 

PURCHASE, NY – June 24, 2026 – Cognition Therapeutics,
Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing product candidates
that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration
(FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy
bodies (DLB) could be an approvable outcome and reached alignment with the Company on key aspects of a pivotal trial to support
a New Drug Application (NDA). The registrational program is expected to begin in mid-2027.

 

As discussed with the FDA, Cognition expects the Phase 3 study will
enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment
with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100
mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details
for the use of the neuropsychiatric inventory (NPI) as a novel primary endpoint for a pivotal trial in DLB psychosis.

 

“We reached an important agreement
with the FDA that DLB psychosis is an approvable outcome and that key aspects of our registrational trial design are appropriate and supportive
of an NDA,” explained Anthony O. Caggiano, MD, PhD, chief medical officer of Cognition. “To
date, few drugs have been researched for DLB and none have been approved. The only recourse for DLB patients experiencing psychosis is
the off-label use of potentially dangerous antipsychotics.” 

 

The proposed Phase 3 study builds on findings from Cognition's Phase
2 COG1201 ‘SHIMMER’ trial in mild-to-moderate DLB, which demonstrated improvements in psychosis symptoms with zervimesine
versus placebo as measured by the NPI. In a recent analysis of results from the Phase 2 study, zervimesine slowed progression of hallucinations
and delusions by 89%. In July, the Company will present additional analyses from the Phase 2 study showing zervimesine’s impact
on the hallucination and delusion components of the NPI at the Alzheimer’s Association’s International Conference (AAIC).

 

“Working with the FDA, we intend
to find a path forward for a patient population that has waited too long,” said Lisa Ricciardi, president and CEO.
 “Our ultimate goal is to provide patients and their families with a durable treatment option for DLB psychosis that actually slows
the progression of hallucinations and delusions.”

 

About Cognition Therapeutics 

 

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical
company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the
development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve
disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers
drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s,
among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated
promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes
of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth
solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com.

 

Cognition Therapeutics, Inc.

www.cogrx.com

 

  

  

 

 

About DLB Psychosis

 

Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative
disease characterized by neuropsychiatric, cognitive and motor deficits. Up to 80% of people living with DLB experience psychosis, which
manifests primarily as debilitating hallucinations and delusions. These symptoms are frequently cited as the most challenging for patients
and their care partners to manage. There are no FDA-approved drugs for DLB, and the off-label use of traditional antipsychotics is
often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need.

 

About Zervimesine (CT1812) 

 

Zervimesine (CT1812) is currently being studied in the Phase
2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have concluded
in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in
part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine
into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to
date.

 

The USAN Council has adopted zervimesine as the United States Adopted
Name (USAN) for CT1812.

 

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 any expected or implied benefits or results, including
that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans,
including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding
our regulatory plans, are forward-looking statements. These statements, including statements relating to the study design, 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 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 Capital 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. [email protected]
 Mike Moyer (investors)
 LifeSci Advisors
 [email protected]  

 

 

Cognition Therapeutics, Inc.

www.cogrx.com