New trial to test effectiveness of COYA 302 to slow ALS progression
Coya's ALSTARS will enroll up to 120 adults at sites in US, Canada
Coya Therapeutics has launched a Phase 2 clinical trial of COYA 302 — an experimental therapy combining the signaling molecule IL-2 with CTLA4-Ig, also known as abatacept — to evaluate whether its use can slow disease progression in adults with amyotrophic lateral sclerosis (ALS) over a six-month period.
The trial, dubbed ALSTARS (NCT07161999), will recruit an estimated 120 people, ages 18 to 75, who have been diagnosed with sporadic or familial ALS but have had symptoms for no more than two years. Two U.S. sites are preparing to open for recruitment, with additional locations expected to follow. According to Coya, the trial will involve approximately 25 study centers in the U.S. and Canada.
“The launch of the ALSTARS trial represents a significant milestone in our mission to develop innovative therapies for patients with ALS,” Fred Grossman, Coya’s chief medical officer, said in a company press release. “We look forward to evaluating [COYA 302’s] potential to meaningfully impact the lives of ALS patients and their families.”
ALS is a progressive disease in which motor neurons — the nerve cells that control muscle movement — gradually become damaged and die, leading to muscle weakness. What causes ALS is unclear, but inflammation and an overactive immune system may play a role.
Medication in COYA 302 used to treat certain types of arthritis
COYA 302 combines a low dose of IL-2, a signaling molecule, with CTLA4-Ig — also called abatacept, this biologic agent is marketed as Orencia in the U.S. and Europe for treating certain types of arthritis. The abatacept in COYA 302 is a biosimilar, meaning it is designed to act in a manner closely similar to Orencia.
Given as an injection under the skin, or subcutaneously, COYA 302 is expected to calm an overly active immune system and slow the progression of ALS. It is designed to work by increasing the activity of regulatory T-cells, a type of white blood cell that keeps immune cells in check and reduces inflammation.
“We believe COYA 302’s unique mechanism of enhancing regulatory [T-cell] number and function offers a promising new approach [toward] developing a potential therapy for this devastating disease with high unmet medical need,” Grossman said.
In an open-label, proof-of-concept clinical trial involving four ALS patients, treatment with COYA 302 for nearly one year was found to slow disease progression. COYA 302 also was shown to be safe and well tolerated in that small trial, conducted at the Houston Methodist Research Institute in Texas.
We believe COYA 302’s unique mechanism of enhancing regulatory [T-cell] number and function offers a promising new approach [toward] developing a potential therapy for this devastating disease with high unmet medical need.
To be eligible for ALSTARS, patients must be experiencing a monthly decline of 0.5 to 1.5 points on the ALS Functional Rating Scale-Revised (ALSFRS-R), for which lower scores indicate greater limitations in daily activities. Individuals already on treatments for ALS must be on stable doses and continue them, or be willing to avoid starting them during the clinical trial.
Participants will be randomly assigned to receive one of two different doses of COYA 302, or a placebo, for 24 weeks, or about six months. Those who complete this period will be invited to join an open-label extension in which all will receive COYA 302 at one of the two doses for an additional 24 weeks.
The main goal is to watch for changes in ALSFRS-R scores over the first 24 weeks of the clinical trial. Secondary goals include measuring the levels of neurofilament light chain (NfL), a biomarker of damage to nerve cells, as well as monitoring lung function and survival.
ALSTARS is affiliated with the Northeast ALS Consortium (NEALS), the world’s largest ALS research network. James Berry, MD, cochair of NEALS, will provide an overview of COYA 302 and the design of the clinical trial in a webinar on Sept. 29. Registration for that webinar is now open.
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