FDA OKs 1st-in-Human Clinical Trials of STAR-0215 HAE Treatment
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 1 clinical trial (NCT05477160) in healthy adults in the coming weeks.
Recruitment will take place at Spaulding Clinical Research, near Milwaukee, in southeast Wisconsin. If all goes as planned, preliminary data from the trial will be available by the end of this year, the company said in a press release.
“The acceptance of our IND by the FDA is an important next step in bringing STAR-0215 to the clinic for our planned first-in-human trial,” said Chris Morabito, MD, Astria’s chief medical officer.
STAR-0215 is a monoclonal antibody that is designed to bind to and inhibit plasma kallikrein. High levels of this protein are the underlying cause of HAE, and lead to debilitating and sometimes life-threatening swelling in the body.
The experimental therapy has a similar mechanism of action to that of Takhzyro (lanadelumab), an approved medication used to prevent swelling attacks in people with HAE.
Preclinical studies have suggested, however, that STAR-0215 may require less frequent dosing.
Takhzyro, marketed by Takeda, is given via under-the-skin (subcutaneous) injections every two weeks. Its dosing may be extended to once a month if patients remain attack free for at least six months.
STAR-0215 has been shown to be about 10 times more potent than Takhzyro. Moreover, in studies with cynomolgus monkeys — a nonhuman primate model better known as a macaque — it remained in circulation at therapeutic levels for much longer periods, specifically 84 days versus 10 days.
These early findings suggest that STAR-0215 could be given once every three months, and possibly at even greater intervals.
“We are optimistic that STAR-0215’s differentiated profile, including dosing once every three months or longer, has the potential to change the way that people with HAE live with their disease,” Morabito said.
In the upcoming clinical trial, the company will test the safety and tolerability of STAR-0215 in healthy volunteers.
The study will enroll up to 24 individuals, ages 18 to 60, who are in good health and have a body mass index of 18 to 35 kilograms (kg)/square meter (39.6 lbs to 77 lbs). Participants who are capable of having a baby must agree to use effective contraception.
Each person will be randomly assigned to receive either a placebo or one of three STAR-0215 dosages, given via a single under-the-skin injection. Neither researchers nor participants will know which individuals are receiving the medication and which the placebo.
The trial’s primary goal is to determine the number of participants who experience treatment-related side effects over about 7.5 months following the injection.
In addition, researchers will examine a number of secondary measures, including blood levels of STAR-0215 over time, kallikrein activity, and the proportion of participants who develop antibodies against STAR-0215.