Astria Launches Phase 1 Trial of STAR-0215 in Healthy Adults

Preclinical animal data showed STAR-0215 levels stayed in the bloodstream longer than Takhzyro

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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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 (FDA) gave the company the green light to begin clinical testing in humans. If all turns out as planned, preliminary data from the study will be out by the end of this year.

“The initiation of the Phase 1a trial of STAR-0215 in healthy subjects is an important milestone for us, as it marks our progression to a clinical-stage company and is a critical next step towards our goal of improving the disease burden for people living with HAE,” Chris Morabito, MD, Astria’s chief medical officer, said in a press release.

STAR-0215 is designed to bind and block the activity of plasma kallikrein, a protein that increases the levels of bradykinin. Bradykinin is a peptide (small protein) that triggers inflammation in the body. It makes blood vessels dilate and leak fluids into nearby tissues, causing them to swell.

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In HAE, kallikrein becomes overactive and causes bradykinin to build up. As a result, patients have recurrent swelling attacks that can happen suddenly and anywhere in the body. Without preventive treatment, they can be triggered as often as every week and symptoms can last for days. By blocking kallikrein, STAR-0215 is expected to lower bradykinin levels and prevent the attacks.

The antibody works in a way similar to Takeda’s Takhzyro (lanadelumab), a medicine approved for preventing swelling attacks in HAE. Takhzyro is given as an injection under the skin, usually once every two weeks. If patients remain free of swelling attacks for more than six months, doctors can reduce the frequency of injection to about once every month.

Preclinical animal data showed it takes more than three times longer for STAR-0215 levels in the bloodstream to drop by half compared with Takhzyro. Predictions also indicated STAR-0215 can block the action of plasma kallikrein for around 84 days following an injection. These findings suggested that the starting doses of STAR-0215 may be more spaced out compared with Takhzyro and given once every three months or perhaps at even larger intervals.

Now the company is aiming to provide evidence the same holds true in humans. The recently launched Phase 1a trial (NCT05477160) is taking place at a single location in Spaulding Clinical Research, West Bend, Wisconsin.

It’s enrolling up to 24 healthy adults, ages 18 to 60, who have a body mass index of 18 to 35 kilograms (kg) per square meter. Female participants who are capable of becoming pregnant must agree to use effective contraception.

Each participant will be randomly assigned to receive a single under-the-skin injection of either 100, 300, or 600 mg of STAR-0215, or a placebo. Neither the participants nor the researchers will know which treatment participants are receiving until the trial is completed.

The trial’s primary outcome measure, or goal, is to determine how safe STAR-0215 is by assessing the number of participants who experience treatment-emergent side effects within 224 days (about 7.5 months) following an injection.

The researchers will also study how STAR-0215 moves into, through, and out of the body by determining its levels in the blood, and how well it works by measuring the activity of plasma kallikrein. They will also determine the number of participants who develop antibodies against STAR-0215.

“We are proud of our progress so far, and the initiation of our first clinical trial in HAE is a representation of our commitment to bringing hope with life-changing therapies to patients affected by rare diseases,” Morabito said.