Coya to meet with FDA about a Phase 2 trial of COYA 302 for ALS
Once approved, the company is planning to start the trial next year
Coya Therapeutics is planning to file a request with the U.S. Food and Drug Administration (FDA) to continue testing its investigational therapy COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS) in a Phase 2 clinical trial.
The company is preparing a meeting with the regulatory agency to discuss its development plans and ensure they align with FDA expectations and requirements before submitting the investigational new drug (IND) application.
The pre-IND meeting will take place this fall, and the company is hoping to have the application cleared early next year, with plans to initiate the clinical trial soon thereafter.
“We are preparing for a pre-IND meeting with the FDA in the fall of 2023,” Howard Berman, PhD, CEO of Coya, said in a company press release. “We hope to have our IND application for a phase 2 trial accepted by the FDA early next year and are optimistic the trial can begin soon thereafter.”
ALS is marked by the progressive damage and death of motor neurons, the nerve cells that control voluntary movements. With the loss of these neurons, the brain becomes less and less able to control muscle movement.
COYA 302 is a combination of the immune signaling molecule interleukin-2 (IL-2) and a fusion protein named CTLA4-Ig or abatacept. It is administered via a subcutaneous (under-the-skin) injection.
Reducing inflammation, decreasing activity of damaging immune cells
The low-dose IL-2 in the combination is intended to reduce inflammation by increasing the activity of anti-inflammatory immune cells called regulatory T-cells (Tregs). CTLA4-Ig, in turn, is designed to decrease the activity of immune cells that promote inflammation and damage in ALS.
The therapy was tested in a small proof-of-concept trial involving four people with ALS. Participants were treated with COYA 302 for 48 weeks and were followed for eight more weeks after stopping the medication.
Results showed that COYA 302 resulted in a considerable slowing of disease progression. While participants were losing about 1.1 points per month in the ALS Functional Rating Scale (ALSFRS-R) — a measure of functional ability — before starting on COYA 302, they lost an average of 1.5 points in the whole trial duration.
However, once patients stopped the treatment, disease progression rates went back to those observed before treatment.
Analysis of immune cell function showed similar findings, with Treg activity increasing during treatment as expected, but decreasing once patients stopped treatment. Other markers of inflammation and oxidative stress, a type of cell damage associated with inflammation, also decreased with COYA 302.
The therapy was generally well tolerated, with no serious side effects described. The most common side effects were injection site reactions, which were mostly mild in severity.
Coya now expects to release data from biomarker analyses, and also publish full results from the trial in a peer-reviewed journal, before year’s end.