MW Cognition Therapeutics announces positive results from trial of oral treatment for mild-to-moderate Alzheimer's disease
By Ciara Linnane
Cognition Therapeutics Inc. on Monday announced positive results from a Phase 2 trial of an oral treatment for mild-to-moderate Alzheimer's disease that showed 40% mean improvement in cognitive measures compared with placebo.
The Purchase, N.Y.-based company $(CGTX)$ said the trial, called Shine, found patients treated with its experimental pill CT1812 for six months showed a consistent trend in cognitive improvement across all measures and cognitive scales.
"The SHINE trial showed that after 182 days of treatment, CT1812 demonstrated evidence of clinical improvements on cognition coupled with a favorable safety and tolerability profile, particularly in the 100mg dose cohort," Chief Executive Lisa Ricciardi said in prepared remarks.
"We believe these results provide evidence that amyloid oligomer antagonism - a new and distinct mechanism for therapeutic intervention - may have a role as a monotherapy or in a combination with approved drugs for the treatment of AD and related dementias."
The results were comparable in magnitude to what was achieved with currently approved antibodies, with great ease of administration as a daily pill and less patient burden, she added.
The trial involved 153 adults who were randomly assigned one or two oral daily doses of 100mg or 300mg or placebo.
"We intend to utilize these findings to enable us to design and power future clinical trials to advance the development of CT1812 in Alzheimer's disease.," said Anthony Caggiano, chief medical officer and head of R&D. "We believe that the data supports the advancement of a 100mg dose of CT1812 in additional clinical trials in a mild-to-moderate patient population."
The company is still analyzing the data, but found favorable changes in neurofilament light chain, or NfL, which is a marker of neurodegenerative disease. The changes were significant at the 300mg dose.
The details of the findings are being reported in posters at the Alzheimer's Association's International Conference taking place Monday in Philadelphia.
The company is now looking to the results of its Shimmer trial in mild-to-moderate Lewy body dementia, which are expected later this year, Ricciardi said.
The company is also studying patients with early-stage Alzheimer's in a trial involving 540 patients, called Start.
The data come just days after European regulators gave a thumbs down to Biogen's Alzheimer's disease treatment, which it markets jointly with Eisai Co. Ltd.
Cognition's stock rose 7% premarket after resuming trade following a halt. It has gained 28% in the year to date, while the SPDR S&P Biotech ETF XBI has gained 14% and the S&P 500 SPX has gained 14.5%.
-Ciara Linnane
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July 29, 2024 08:26 ET (12:26 GMT)
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