FDA Places CT1812, Potential Disease-Modifying Alzheimer’s Treatment, on Fast Track

The U.S. Food and Drug Administration (FDA) has placed CT1812 on fast track as a potential treatment of patients with Alzheimer’s disease (AD), the investigative therapy’s developer,  Cognition Therapeutics, has announced.

CT1812 is a first-in-class, orally administered small molecule designed to inhibit the binding of amyloid beta oligomers to nerve cell receptors in the brain. Amyloid beta oligomers are thought to  play a critical role in the development of AD.

CT1812 works to displace beta amyloid oligomers from their binding sites on neurons allowing them to clear into the cerebrospinal fluid. In doing so, it is designed to decrease the toxic effects of amyloid beta by allowing synapses (the connection between two nerve cells) to regenerate, potentially improving cognition in Alzheimer’s patients.

Studies in animal models of AD have suggested that CT1812 might reverse memory loss and stop disease progression.

A randomized and placebo-controlled Phase 1b/2 clinical trial (NCT02907567) recently concluded in mild-to-moderate AD patients. The trial evaluated CT1812 for its safety and tolerability, with participants given either one of two doses (280mg or 560mg) CT1812, or a placebo,  daily for 28 days.

First results will be presented at the Clinical Trials on Alzheimer’s disease (CTAD) meeting in Boston, taking place Nov. 1–4.

Cognition also conducted a Phase 1 trial in 114 healthy adults, ages 18 to 75, in Melbourne, Australia, from September 2015 to May 2016. At an AAIC (Alzheimer’s Association) conference that year, company scientists reported that single doses up to 1,120 mg, and multiple doses of up to 560 mg, were well-tolerated, with suitable pharmacokinetics (drug behavior once in the body) and sufficient brain penetrance.

“There are few drugs available for the treatment of Alzheimer’s disease and none are disease modifying,” Kenneth Moch, president and chief executive officer of Cognition, said in a press release. “We look forward to collaborating with the FDA to advance CT1812 through clinical development to commercialization, where we hope it will significantly improve the quality of life of people living with this devastating disease.”

Fast track is a designation designed to expedite FDA review of potential new treatments for serious or life-threatening conditions, and those that address an unmet medical need. Such reviews are required by the FDA before a drug can be approved for use in the United States.