PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company, has announced the completion of its Phase 2 SHIMMER study of CT1812, a drug candidate for the treatment of mild-to-moderate dementia with Lewy bodies (DLB). The final patient visit has recently occurred, and the company expects to report the study's topline results in December 2024.
DLB is the second most prevalent form of dementia, affecting around 1.4 million individuals in the United States. It is characterized by the accumulation of alpha-synuclein proteins within brain neurons, which impairs various bodily systems and can result in fluctuating cognition, hallucinations, movement disorders, and sleep disturbances. Currently, there are limited treatments available for DLB, and none that modify the disease's progression.
The SHIMMER study, a double-blind, placebo-controlled trial, enrolled 130 adults with mild-to-moderate DLB. Participants were randomized to receive either a placebo or one of two oral doses of CT1812 over a six-month period. Cognitive and motor functions of the participants were assessed using standardized tests.
CT1812 is described as an orally delivered small molecule that targets the sigma-2 receptor complex within the brain, potentially interfering with disease processes such as protein aggregation and oxidative stress, which are believed to contribute to synaptic damage and cognitive impairment.
The study received substantial support from a grant awarded by the National Institute on Aging of the National Institutes of Health (NIH), amounting to approximately $30 million. It was conducted in collaboration with various institutions, including the Lewy Body Dementia Association (LBDA).
Cognition Therapeutics expressed gratitude to the patients, caregivers, investigators, the National Institute of Aging, LBDA, and the DLB community for their involvement in the study. The company's president and CEO, Lisa Ricciardi, stated their eagerness to analyze the study's findings to understand CT1812's safety and efficacy.
The company is also conducting other clinical trials, including studies on Alzheimer's disease and dry age-related macular degeneration, using its pipeline of sigma-2 receptor modulators.
This news article is based on a press release statement from Cognition Therapeutics, Inc.
In other recent news, Cognition Therapeutics has made significant strides in its Alzheimer's research. The biopharmaceutical company's Phase 2 SHINE study of the investigational drug CT1812 revealed a significant slowing of cognitive decline in Alzheimer's patients with lower plasma p-tau217 levels. The study was supported by the National Institute on Aging of the National Institutes of Health. In addition, Cognition Therapeutics published a study in The Journal of Prevention of Alzheimer's Disease, demonstrating potential benefits of CT1812 in improving brain wave patterns and connectivity in Alzheimer's patients.
H.C. Wainwright reaffirmed its Buy rating and $5.00 price target on shares of Cognition Therapeutics, reflecting positive study results for the company's Alzheimer's treatment. The firm's confidence in the company's stock follows the presentation of these results at a recent medical conference.
During its second quarter 2024 earnings call, Cognition Therapeutics reported a net loss of $7 million, with an increase in research and development expenses. However, the company holds $28.5 million in cash and cash equivalents, which is expected to fund operations until the second quarter of 2025. As part of its future plans, Cognition Therapeutics is evaluating options to extend its cash runway and support later-stage trials.
InvestingPro Insights
As Cognition Therapeutics (NASDAQ: CGTX) awaits the results of its Phase 2 SHIMMER study, investors should be aware of some key financial metrics and trends. According to InvestingPro data, the company's market capitalization stands at a modest $16.33 million, reflecting the early-stage nature of its drug development efforts.
InvestingPro Tips highlight that CGTX holds more cash than debt on its balance sheet, which is crucial for a clinical-stage biopharmaceutical company as it provides financial flexibility to continue its research and development activities. This is particularly important given that the company is quickly burning through cash, another InvestingPro Tip that underscores the capital-intensive nature of drug development.
The stock's performance has been challenging, with InvestingPro data showing a significant 42.11% price decline over the past three months. This downward trend is further emphasized by an InvestingPro Tip indicating that the stock has taken a big hit over the last week and month, suggesting investor caution or potential market concerns about the company's prospects.
It's worth noting that analysts do not anticipate the company to be profitable this year, which is not uncommon for early-stage biotech firms focused on research and development. The upcoming topline results from the SHIMMER study in December 2024 could be a pivotal moment for the company and its stock performance.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights, with 12 more tips available for CGTX on the platform.
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