STAR-0215 for Hereditary Angioedema

This trial tests a new drug, STAR-0215 (also known as Navenibart), for individuals with hereditary angioedema (HAE), a condition that causes sudden swelling in areas like the skin and throat. The trial will examine how different doses of STAR-0215 affect HAE symptoms, with one group receiving a single dose and two other groups receiving two doses. Suitable candidates must have a confirmed HAE diagnosis and have experienced at least two recent swelling attacks. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

You may need to stop taking certain medications before joining the trial. Specifically, you must stop using some HAE prevention therapies, certain blood pressure medications, estrogen-containing medications, and androgens for a specified period before the trial starts.

Research has shown that STAR-0215, also known as Navenibart, has been safe in earlier studies. In one study with 16 participants, the treatment was well-tolerated, and no major negative side effects were reported. Another study found that STAR-0215 reduced the number and severity of hereditary angioedema (HAE) attacks, demonstrating its potential benefits. While this information suggests STAR-0215 is safe, this trial aims to confirm these findings further.¹²³⁴⁵

Unlike the standard treatments for Hereditary Angioedema, which often involve regular injections or infusions to manage attacks, STAR-0215 is designed to provide longer-lasting protection with fewer doses. Researchers are excited about STAR-0215 because it targets the kallikrein-kinin system, potentially offering a novel approach to prevent swelling attacks by inhibiting plasma kallikrein. This could mean fewer treatments and more convenience for patients, with Cohort 1 receiving a single dose and Cohorts 2 and 3 exploring the effects of multiple doses given months or just a month apart.

Research shows that STAR-0215, also known as Navenibart, can reduce the frequency and severity of hereditary angioedema (HAE) attacks. In an earlier study, STAR-0215 lowered the need for emergency medication, resulting in fewer and less intense HAE attacks. Initial results revealed that 50% of participants experienced no attacks over six months. This trial will test STAR-0215 in different dosing regimens: a single dose in one cohort and multiple doses in two other cohorts. These findings suggest that STAR-0215 could effectively treat HAE.¹²³⁴⁶