FDA puts injection therapy COYA 302 on fast track for treating ALS
Drug candidate aims to slow disease progression among patients
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- COYA 302, an injection therapy in development for the treatment of ALS, has been awarded fast track status by the U.S. Food and Drug Administration.
- The therapy aims to slow ALS progression by reducing inflammation in the brain.
- A North American clinical trial is now testing COYA 302 in more than 100 people with ALS.
COYA 302, Coya Therapeutics’ investigational therapy for amyotrophic lateral sclerosis (ALS) — shown in an early clinical trial to slow disease progression in a small number of patients — has been awarded fast track status by the U.S. Food and Drug Administration (FDA).
That designation is intended to accelerate the development and review of therapies for serious conditions with unmet medical needs. It allows for more frequent interactions with the FDA throughout a drug’s development, and may make COYA 302 eligible for a rolling review and accelerated approval if data from ongoing and future studies support a marketing application. The goal of such status, Coya noted in a company press release, is to help promising therapies reach patients more quickly.
“We are pleased to announce that COYA 302 has received FDA Fast Track designation for the treatment of ALS,” said Arun Swaminathan, PhD, Coya’s CEO. “This recognition underscores the devastating nature of ALS and the urgent need for new therapies.”
ALS is a neurodegenerative disease marked by the progressive loss of motor neurons, the nerve cells that control voluntary movement in the body. While the condition’s exact causes remain largely unknown, evidence suggests that excessive inflammation in the brain, driven by an overly active immune system, may contribute to disease progression.
COYA 302 designed to reduce inflammation in brain
COYA 302, administered via a subcutaneous, or under-the-skin, injection, is an investigational therapy designed to reduce such inflammation and potentially slow the progression of ALS.
The medication combines low-dose interleukin-2 (IL-2), a signaling molecule that’s intended to boost the activity of anti-inflammatory immune cells called regulatory T-cells, with the fusion protein CTLA4-Ig, also known as abatacept.
That treatment, approved for certain types of arthritis, aims to suppress the activity of immune cells that promote inflammation and contribute to nerve cell damage in ALS.
The therapy has already been tested in a small proof-of-concept Phase 1 clinical trial involving four people with ALS. In that trial, the use of COYA 302 for nearly one year was found to slow disease progression and reduce levels of disease biomarkers.
Before starting treatment, the participants in that study were experiencing progressive worsening of their ability to perform daily activities, as reflected by a mean monthly decline of 1.1 points on the ALS Functional Rating Scale-Revised (ALSFRS-R), a standard measure of physical function in ALS.
After about a year of treatment, the mean monthly decline on the ALSFRS-R slowed to 0.13 points. One participant experienced a marked functional improvement during treatment, with an 11-point increase in the ALSFRS-R score. Even after excluding that patient from the analysis, the remaining three participants still showed a mean monthly decline of 0.47 points, less than half the rate seen before treatment.
All participants who had elevated levels of biomarkers linked to inflammation, oxidative stress — a type of cell damage often associated with inflammation — and nerve injury before treatment showed trends toward reductions in those biomarkers after 16 weeks, or about four months, of therapy. The combination therapy was also generally safe and well tolerated, with only mild adverse events reported.
Therapy now being tested in large North American trial
COYA 302 is now being evaluated in an ongoing Phase 2 clinical trial, dubbed ALSTARS (NCT07161999), which is being conducted at sites in the U.S. and Canada. The study is expected to involve 120 people, ages 18 to 75, whose symptoms began no more than 28 months, or about 2.3 years, before entering the trial.
Participants are randomly assigned to receive one of two dosing regimens of COYA 302 or a placebo over 24 weeks, or about six months. Treatment will be given as a subcutaneous injection for five consecutive days every other week, and patients will be allowed to continue on their ALS therapies.
The trial’s main goal is to assess changes in ALSFRS-R scores at the end of treatment. Secondary outcomes will evaluate the therapy’s effects on a combined measure of functional decline and survival, lung function, and biomarkers of nerve damage.
After completing the randomized portion of ALSTARS, participants may be eligible to enter an extension phase and receive COYA 302 for an additional six months.
According to Coya, full enrollment is expected in the second half of this year, with top-line data anticipated in the first quarter of 2027.
“At Coya, we remain fully committed to advancing our lead biologic candidate, COYA 302, through the regulatory process with the ultimate goal of delivering — pending FDA approval — a safe and effective treatment for patients living with ALS and their families,” Swaminathan said.
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