Alys Pharmaceuticals has started testing a new drug, ALY-301, in its first human trial. This drug is designed to help people with Cold Urticaria, a type of Chronic Inducible Urticaria. The trial will include both healthy volunteers and patients with Cold Urticaria. The first results are expected in 2026. The main goals of the trial are to check the safety, how well the body tolerates the drug, and how it works in the body. They will also look for early signs that the drug is effective, especially in patients who still have symptoms even after taking antihistamines.
Professor Martin Metz, who is leading the trial, said: “Chronic Urticaria is a disease where the impact on patients is often not fully understood. ALY-301’s ability to specifically target and reduce mast cells, while potentially being as effective as other similar drugs, makes it one of the most promising treatments I have seen. This shows the potential of precise, targeted therapies in treating skin conditions caused by the immune system.”
Thibaud Portal, Co-Founder and Chief Operating Officer of Alys Pharmaceuticals, said: “Starting to test ALY-301 in people is a big step for Alys. With the first-ever drug of this kind now in trials, Alys is leading the way in developing new treatments for skin conditions caused by the immune system. This brings us closer to our goal of providing innovative treatments for patients who need them the most.”
Professor Lars French, Chief Medical Officer of Alys Pharmaceuticals, added: “Starting this clinical trial is very exciting because it is the first time we will be able to see how well our unique drug, ALY-301, works in patients. This drug is designed to specifically target and inhibit mast cell c-Kit, while not affecting other cells that also have c-Kit, such as melanocytes and hematopoietic stem cells.”
He added: “The unique features of ALY-301 give it the potential to be a game-changer for the long-term management of Chronic Urticaria.”