Coya gets FDA clearance to start Phase 2 trial of ALS treatment
Multicenter study will test treatment for 24 weeks
Coya Therapeutics is preparing to launch a Phase 2 clinical trial in the U.S. to test its COYA 302 as an amyotrophic lateral sclerosis (ALS) treatment.
The company said the U.S. Food and Drug Administration accepted its investigational new drug (IND) application after it submitted additional data the agency had requested.
The multicenter study will test the safety and efficacy of COYA 302 against a placebo when taken for 24 weeks, or about six months. Participants will then be able to join an open-label extension, where all will receive the experimental therapy for another six months.
“The FDA’s acceptance of this IND marks a pivotal moment in Coya’s journey,” Arun Swaminathan, Coya’s CEO, said in a company press release. “We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS.”
COYA 302 is designed to slow disease progression by targeting two key contributors to ALS progression: neuroinflammation and oxidative stress, a type of cellular damage.
Treatment slowed disease progression in early trial
The medication combines a low dose of interleukin-2 (IL-2), a signaling molecule intended to boost regulatory T cells — immune cells that help control inflammation — with the protein CTLA4-Ig, which dials down overactive inflammatory immune cells. This dual mechanism of action is expected to ease inflammation and the oxidative stress that often follows, helping to slow disease progression.
COYA 302 slowed disease progression and reduced levels of disease biomarkers in a proof-of-concept study, in which four adults with ALS received subcutaneous (under-the-skin) injections of the medication for nearly one year.
Before treatment, all four patients were experiencing declines in their functional ability, as indicated by a mean 1.1-point monthly loss in the ALS Functional Rating Scale (ALSFRS-R). Declines slowed over the year of treatment to an average of 0.13 points per month. One patient saw considerable functional improvement during the trial, with an 11-point rise in the ALSFRS-R score. When this participant was excluded from the analyses, rates of decline in the remaining three patients were still less than half of those seen before treatment (0.47 points per month).
COYA 302 also eased several relevant markers of inflammation, oxidative stress, and nerve cell damage. Participants generally tolerated the therapy well, with only mild adverse events reported.
Dr. Reddy’s Laboratories has exclusive rights to market COYA 302 in the U.S., Canada, the U.K., and the European Union, should it be approved in those countries. The IND acceptance triggered a $4.2 million payment from Dr. Reddy’s to Coya.
“We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study,” said Milan Kalawadia, Dr. Reddy’s North America CEO. “This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS.”
Coya submitted the additional data the FDA had requested in June, and a decision on the IND was initially expected by July 30. However, the agency informed Coya that it would not meet the review goal date due to a lack of resources. Coya announced the application’s acceptance on Aug. 25.
About the Author
