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PITTSBURGH - Cognition Therapeutics, Inc. (NASDAQ:CGTX), a clinical-stage biotech company with a market capitalization of $40.5 million, has published results from its Phase 2 SEQUEL study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer’s disease, showing promising effects on brain activity. The company’s stock has shown strong momentum, gaining over 8% in the past week according to InvestingPro data.
The study, published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, investigated zervimesine’s impact on synaptic function using quantitative electroencephalography (qEEG).
According to the company’s press release statement, treatment with zervimesine showed trends of improvement across all prespecified EEG parameters after 29 days compared to placebo. The drug appeared to reduce theta waves, suggesting potential normalization of neuronal and synaptic function.
The company also reported that zervimesine treatment was associated with improvement in global alpha AEC-c, a measure of functional connectivity between brain regions.
Proteomics analysis identified proteins altered by zervimesine treatment that are associated with vesicle formation, exocytosis and endosomal trafficking - cellular functions that help neurons recycle and eject debris.
In additional laboratory studies using human-derived neurons, the company found that zervimesine preserved cell viability when exposed to 4-Hydroxynonenal (4-HNE), a molecule that induces oxidative stress and is found at high levels in brains affected by neurodegenerative diseases.
The SEQUEL study enrolled 16 adults with mild-to-moderate Alzheimer’s disease, 15 of whom completed the trial. Participants received either 300mg zervimesine or placebo once daily for 29 days, followed by a 14-day washout period before crossing over to the other treatment arm.
The study was supported by a $5.3 million grant from the National Institute of Aging of the National Institutes of Health.
Zervimesine has been granted FDA Fast Track designation in Alzheimer’s disease. The company is also evaluating the drug in dementia with Lewy bodies and geographic atrophy secondary to dry AMD.
In other recent news, Cognition Therapeutics has been in the spotlight following several key developments. The company announced the results of its Phase 2 SHIMMER study for its dementia with Lewy bodies treatment, zervimesine, which showed promising results in slowing the progression of symptoms. Additionally, Cognition presented findings from its Phase 2 SHINE study in Alzheimer’s patients, demonstrating preserved cognitive and functional abilities compared to placebo. The company recently completed an end-of-Phase 2 meeting with the FDA regarding zervimesine for Alzheimer’s, discussing plans for a Phase 3 program. Cognition expects to receive formal feedback from the FDA soon, which could clarify the drug’s development path. H.C. Wainwright reiterated its Buy rating on Cognition Therapeutics, maintaining a price target of $3.00, following the company’s discussions with the FDA and the progress of its Phase 2 START Study. The START Study, which is evaluating zervimesine in mild Alzheimer’s patients, has surpassed 50% enrollment. This study is supported by significant grant funding from the National Institute of Aging. These developments highlight Cognition’s ongoing efforts in advancing treatments for neurodegenerative diseases.
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