Alzheimer's Drug Fails Cognitive Endpoint

Shares of Cognition Therapeutics fell nearly 43% on Monday following the release of Phase II data concerning their Alzheimer's disease (AD) therapy, CT1812. The SHINE study, which involved 153 adults with mild-to-moderate AD, compared the effects of a 100-mg or 300-mg daily oral dose of CT1812 to a placebo over six months. The findings were presented at the Alzheimer’s Association International Conference (AAIC).

Despite the setback, Cognition maintained a positive outlook, emphasizing that combined data from both dosages of CT1812 showed a statistically significant cognitive improvement at day 98, the study's midpoint. This was measured using the ADAS-Cog 11 and mini-mental state examination (MMSE) scales. However, the results at day 182 revealed that the treatment did not achieve statistical significance in the primary secondary efficacy endpoints compared to the placebo.

By the end of the six-month period, patients who received CT1812 experienced a 1.66-point decline on the ADAS-Cog 11 scale, compared to a 2.7-point deterioration in the placebo group. This represents a 1.04-point benefit and a 39% reduction in cognitive decline in favor of CT1812. Nevertheless, this benefit fell short of the three-point improvement that Cognition had reported in November, which was based on preliminary results from the first 24 patients enrolled in the SHINE study.

Anthony Caggiano, Cognition’s chief medical officer and head of R&D, stated, “We intend to utilize these findings to design and power future clinical trials to advance the development of CT1812 in Alzheimer’s disease. We believe that the data supports the advancement of a 100-mg dose of CT1812 in additional clinical trials in a mild-to-moderate AD patient population.” Additionally, the 540-patient START study of CT1812 in early-stage AD individuals is still ongoing.

In terms of safety, the SHINE study reported encouraging results. CT1812 displayed a favorable safety and tolerability profile, with a similar proportion of patients in the treatment group (76.5%) experiencing adverse events (AEs) as those in the placebo group (78%). Most AEs were mild or moderate, the most common being urinary tract infections, falls, gastrointestinal issues, and headaches. Only one patient in the treatment group experienced a serious AE related to the therapy, which was recurrent presyncope in the 300-mg dose cohort.

Topline neurofilament light chain (NfL) biomarker data were also disclosed, showing favorable changes in patients treated with CT1812. According to Cognition, these findings support the drug’s role as a synaptoprotective agent, contributing to its safety and efficacy profile.

As the company continues its research, the mixed results of the SHINE study will be used to refine future clinical trials. The ongoing START study and additional planned trials will help determine the optimal use and dosage of CT1812 in treating Alzheimer's disease.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!