FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS

The Food and Drug Administration has granted Fast Track designation to COYA 302, an investigational biologic combination therapy for the treatment of amyotrophic lateral sclerosis. The designation is supported by data from a phase 1 trial that included 4 participants with ALS, and COYA 302 is currently being evaluated in the phase 2 ALSTARS trial in adults with ALS.

COYA 302 is a dual immunomodulatory therapy consisting of low-dose interleukin-2 and a biosimilar candidate for abatacept, a selective costimulation modulator. It is designed to boost anti-inflammatory regulatory T cells and suppress proinflammatory monocytes and macrophages, thereby potentially slowing the progression of ALS.

Findings from the phase 1 trial showed the combination therapy was well tolerated and led to an increase in regulatory T-cell numbers and suppressive function. Consistent reductions in neuroinflammation and oxidative stress were also observed.

In the phase 2 ALSTARS trial, adults with ALS with time of onset of symptoms 28 months or less from screening and a Revised Amyotrophic Lateral Sclerosis Functional Rating Scale total score of 35 or higher will be randomly assigned to receive 1 of 2 regimens of COYA 302 or placebo via subcutaneous injection. The primary endpoint is the change in disease progression as measured by ALSFRS-R from baseline to week 24.

The Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments. A status update said targeted combination therapy with low-dose IL-2 and CTLA-4 Ig shows promise in slowing ALS progression, supported by early clinical and biomarker data, and that the phase II trial aims to confirm efficacy and safety in a larger patient group.