Astria Therapeutics is on track to start a Phase 3 clinical trial of navenibart, its therapy to prevent swelling attacks in people with hereditary angioedema (HAE), by March. The trial, dubbed ALPHA-ORBIT, will test flexible dosing schedules, with navenibart being given every three months and every six months.

The European Commission has granted orphan medicinal product designation (OMPD) to navenibart, an experimental long-acting therapy for hereditary angioedema (HAE). The designation is aimed at providing incentives for the development of therapies that are meant to diagnose, prevent, or treat rare diseases, or those affecting fewer than 10,000 people…

Astria Therapeutics is teaming up with Ypsomed, a Swiss-based company, to develop an autoinjector for its experimental treatment STAR-0215 for hereditary angioedema (HAE). “With STAR-0215’s profile, our goal is to develop a therapy that allows patients to choose an approach that works best for their lives with…

Treatment with the experimental under-the-skin injection therapy STAR-0215 reduced the rates of monthly swelling attacks by more than 90% in people with hereditary angioedema (HAE) in a small early clinical trial. That’s according to new data announced by developer Astria Therapeutics, which further showed that HAE attacks…

A single subcutaneous or under-the-skin injection of STAR-0215 — an experimental treatment that aims to prevent swelling attacks in people with hereditary angioedema (HAE) — led to a sustained decrease in kallikrein protein activity in healthy adults for close to three months, according to new trial data. Early…

The U.S. Food and Drug Administration (FDA) has given STAR-0215 fast track status to help speed up its development and make it available to patients sooner. An experimental medication to prevent swelling attacks in hereditary angioedema (HAE), with dosing once every three or six months, STAR-0215 is in…

Astria Therapeutics intends to move directly into a pivotal trial to support STAR-0215’s regulatory approval for hereditary angioedema (HAE) if proof-of-concept results from the ongoing Phase 1b/2 trial are positive, the company has announced. Initial results from the trial, called ALPHA-STAR (NCT05695248), are expected in mid-2024. With…

Astria Therapeutics has initiated a Phase 1b/2 trial called ALPHA-STAR to test STAR-0215, the company’s investigational therapy to prevent swelling attacks in people with hereditary angioedema (HAE). ALPHA-STAR (NCT05695248) intends to enroll 18 adults with HAE types 1 or 2 who have had at least four swelling…

Astria Therapeutics has launched a Phase 1a trial in healthy adults to test STAR-0215, an investigational antibody-based therapy designed to prevent swelling attacks in people with hereditary angioedema (HAE), with dosing once every three months or longer. The launch came soon after the U.S. Food and Drug Administration…

The U.S. Food and Drug Administration (FDA) has cleared Astria Therapeutics to move STAR-0215, its experimental treatment for preventing swelling attacks in hereditary angioedema (HAE), into clinical testing. With the positive decision on its investigational new drug (IND) application, the company is now planning to launch a Phase…