MADRID - Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company, presented data at the Clinical Trials on Alzheimer's Disease (CTAD) conference today, revealing significant findings from its Phase 2 SHINE study of the investigational drug CT1812. The study results indicated a dramatic slowing of cognitive decline in mild-to-moderate Alzheimer's disease patients with lower levels of plasma p-tau217, a biomarker of the disease's pathology.
Patients with below-median baseline levels of plasma p-tau217 experienced a 95% slowing in cognitive decline when measured using the ADAS-Cog 11 scale and a 108% slowing as per the MMSE scale, compared to the cognitive decline observed in placebo patients.
Dr. Michael Woodward (NASDAQ:WWD), who presented the analysis, suggested that plasma p-tau217 could serve as a predictive biomarker for treatment effectiveness. Dr. Anthony Caggiano, CMO and head of R&D at Cognition, added that the treatment effect size appears to be increasing over time, with plans to confirm these effects in a longer study. The company is preparing for a Phase 3 trial discussion with the FDA following an end-of-Phase 2 meeting.
The SHINE study, supported by grants from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million, was a double-blind, placebo-controlled trial involving 153 adults. It assessed the safety, tolerability, and cognitive effects of two doses of CT1812 administered orally over six months.
CT1812, the company's lead candidate, is an orally delivered small molecule that targets the sigma-2 receptor complex, potentially displacing toxic Aβ oligomers linked to Alzheimer's disease progression. The drug is also being evaluated in clinical programs for other degenerative conditions.
Cognition Therapeutics will host an investor webinar on October 30, 2024, to review the study findings, with Alzheimer's industry experts participating and a Q&A session to follow. The webinar aims to provide an overview of the results and discuss implications for the company's clinical development plans for CT1812.
This report is based on a press release statement from Cognition Therapeutics, Inc.
In other recent news, Cognition Therapeutics has reported significant developments in its Alzheimer's research. The company's drug candidate, CT1812, demonstrated a 39% slowing in cognitive decline in patients with mild to moderate Alzheimer's disease in the SHINE trial, according to the company's second quarter 2024 earnings call. The trial also indicated a favorable safety profile for CT1812. Furthermore, the SEQUEL study, funded by the National Institute of Aging, suggested potential benefits of CT1812 in improving brain wave patterns and connectivity, which are often impaired in Alzheimer's patients.
Cognition Therapeutics also reported a net loss of $7 million for the quarter, with an increase in research and development expenses. Despite this, the company holds $28.5 million in cash and cash equivalents, sufficient to fund operations until the second quarter of 2025. As part of its future plans, the company is evaluating options to extend its cash runway and support later-stage trials. These recent developments underscore Cognition Therapeutics' commitment to advancing its clinical programs for CT1812 and its potential role in the fight against neurodegenerative diseases.
InvestingPro Insights
Cognition Therapeutics' recent presentation of promising Phase 2 SHINE study results for CT1812 in Alzheimer's disease patients comes at a critical time for the company. According to InvestingPro data, CGTX has a market capitalization of $21.76 million, reflecting its current position as a clinical-stage biopharmaceutical company.
The positive study outcomes are particularly significant given the company's financial situation. InvestingPro Tips indicate that Cognition Therapeutics is "quickly burning through cash" and is "not profitable over the last twelve months." This context underscores the importance of the CT1812 trial results for the company's future prospects.
Despite these challenges, there are some encouraging signs. An InvestingPro Tip notes that "4 analysts have revised their earnings upwards for the upcoming period," suggesting growing optimism about the company's potential. Additionally, CGTX has seen a "strong return over the last month," with a 28.83% price total return in the past month, possibly reflecting market reaction to the anticipated CTAD conference presentation.
It's worth noting that CGTX "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it moves towards Phase 3 trials and potential FDA discussions. However, investors should be aware that the "stock has taken a big hit over the last six months," with a -71.91% price total return in that period.
For those interested in a deeper analysis, InvestingPro offers 13 additional tips for CGTX, providing a more comprehensive view of the company's financial health and market position.
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