Coya aligns with FDA on plans for developing COYA 302 for ALS
Company expects to file by midyear for OK to launch clinical trial of therapy
After two meetings with the U.S. Food and Drug Administration (FDA), Coya Therapeutics says it’s received constructive feedback — and has reached an alignment with the agency regarding development plans for COYA 302, its therapy candidate for people with amyotrophic lateral sclerosis (ALS).
The company held the two meetings — a pre-investigational new drug (IND) meeting and a type C meeting — to seek advice from the FDA. Now, according to COYA, the two parties are in agreement regarding key areas of COYA 302’s development, to include its manufacturing, preclinical research, and clinical studies, which should support the filing of an IND application seeking clearance to start clinical trials.
That application is expected to be submitted in the first half of 2024, the company said in a press release.
If it’s accepted, Coya will soon thereafter launch a double-blind clinical trial to test COYA 302 in people with ALS. In a double-blind study, neither researchers nor participants know what treatment, if any, patients are receiving.
“This important feedback allows us to advance our development program in ALS with a planned double-blind controlled study, with the potential for bringing forward a much-needed therapy for ALS patients,” said Fred Grossman, Coya’s president and chief medical officer.
In proof-of-concept study, COYA 302 showed marked benefits
ALS is characterized by progressive damage to motor neurons, the nerve cells that control voluntary movements. It renders the brain less able to control muscle movements.
COYA 302 is an experimental approach that combines a low dose of the immune signaling molecule interleukin-2 (IL-2) and a fusion protein named CTLA-4 Ig (abatacept).
IL-2 is intended to reduce inflammation by increasing the levels and activity of anti-inflammatory immune cells called regulatory T-cells, or Tregs. CTLA-4 Ig, meanwhile, aims to decrease the activity of immune cells that promote inflammation and damage in ALS.
The therapy, administered via a subcutaneous or under-the-skin injection, has already been tested in four ALS patients in a proof-of-concept clinical trial. The participants received treatment for 48 weeks, or nearly one year, and were followed for eight more weeks after stopping COYA 302.
Results of the small study showed that ALS progression was markedly slowed during the treatment period, with patients experiencing similar levels of disability after 48 weeks compared with before treatment.
Prior to treatment, participants were losing a mean of 1.1 points per month in their ALS Functional Rating Scale (ALSFRS-R) scores, indicating a lower ability to perform daily tasks each month. During the entire study period, scores dropped a total of 1.5 points, on average.
However, once patients stopped COYA 302, progression rates returned to those observed before the trial started, indicating a need for continuous treatment.
Similarly, there was a statistically significant increase in Treg anti-inflammatory activity during the treatment, which also decreased to starting, or baseline, levels eight weeks after treatment discontinuation.
The study also evaluated biomarkers of inflammation and oxidative stress — a type of cell damage associated with inflammation. Available data up to 16 weeks, or about four months, suggested a decrease in these biomarkers, consistent with the observed increase in Treg function.
We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in [the second quarter of] 2024 is an important next step in advancing the program in patients with ALS.
The therapy was generally well tolerated, with no serious side effects reported and no treatment discontinuations. The most common side effects were mild reactions at the injection site.
Coya plans to continue working closely with the FDA throughout COYA 302’s development program, the company said.
“We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in [the second quarter of] 2024 is an important next step in advancing the program in patients with ALS,” said Howard H. Berman, PhD, Coya’s CEO.