Health Canada gives OK to ALSTARS study already underway in US
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Health Canada has cleared the way for people with amyotrophic lateral sclerosis (ALS) living in Canada to join an ongoing clinical trial evaluating Coya Therapeutics’ therapy candidate COYA 302.
The Canadian regulatory agency issued a “no objection” letter that will allow the developer to start enrolling adults in its Phase 2 ALSTARS study (NCT07161999), slated to run through 2027. Coya plans to recruit approximately 120 participants, ages 18 to 75, at a total of about 25 sites in the U.S. and Canada.
Dosing began late last year at sites in the U.S.; clinical locations in Canada have not yet been announced.
“The activation of Canadian sites is an important step forward for the ALSTARS trial that we believe will further enhance recruitment of this important study currently underway in the United States,” Fred Grossman, Coya’s chief medical officer, said in a company press release announcing the Health Canada decision.
“We look forward to working with the Canadian ALS centers, with the goal of potentially delivering new, safe and effective treatments for ALS,” Grossman said.
A progressive disease, ALS is marked by the loss of motor neurons, the nerve cells that control muscle movement. While its exact causes remain unknown, inflammation and an overactive immune system are believed to play a role.
COYA 302 is a combination of IL-2, a signaling molecule, and CTLA4-Ig, an immune-suppressing treatment. Also known as abatacept, CTLA4-Ig is approved in the U.S. and Europe for treating certain types of arthritis.
Together, the two biologic agents are designed to boost the growth and survival of regulatory T-cells — anti-inflammatory cells that control the activity of other immune cells — while simultaneously reducing the levels of proinflammatory T-cells and signaling molecules.
This dual mechanism is expected to reduce inflammation and downstream oxidative stress, a type of cell damage also involved in ALS, thereby slowing disease progression.
In a small proof-of-concept Phase 1 study, COYA 302, administered subcutaneously (under the skin) for nearly one year, slowed disease progression and reduced disease biomarker levels in four adults with ALS.
After receiving permission from the U.S. Food and Drug Administration last year, Coya launched ALSTARS, enrolling participants who have experienced symptoms for no more than two years. The trial involves people with both sporadic ALS, in which the condition occurs spontaneously, and familial ALS, where more than one person in the same biological family is affected by the disease.
To be eligible for enrollment, patients must demonstrate a monthly decline of 0.5 to 1.5 points on the ALS Functional Rating Scale-Revised (ALSFRS-R). Those already receiving ALS therapies must remain on stable dosing or agree not to begin new treatments during the study period.
Participants will be randomly assigned to receive either COYA 302 at one of two doses or a placebo for 24 weeks, or about six months. Treatment will be given as a subcutaneous injection for five consecutive days every other week.
Those who complete this portion may continue into an open-label extension part in which all will receive COYA 302 for 24 weeks.
ALSTARS’ main goal is to determine whether COYA 302 can slow disease progression, as assessed through changes in ALSFRS-R scores, over the first six months. Secondary outcomes include changes in blood neurofilament light chain (NfL) levels, a marker of nerve damage, lung function, and survival.
If the therapy is ultimately approved, Dr. Reddy’s Laboratories has gained exclusive rights to market COYA 302 in the U.S., Canada, the U.K., and the European Union. Coya has retained the rights to market the therapy in Japan, Mexico, and South American countries. The developer will remain responsible for the treatment’s clinical development and regulatory matters in the U.S.
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