Amgen's Rocatinlimab Shows Promise in Phase 3 Eczema Trials

Amgen has reported positive results from two phase 3 clinical trials for rocatinlimab, its $400 million eczema drug candidate. The anti-OX40 antibody demonstrated significant improvements in atopic dermatitis symptoms, potentially positioning it as a competitor to Sanofi and Regeneron's Dupixent.

Ignite and Shuttle Trial Results

The Ignite trial, involving 769 adults with moderate to severe eczema, tested two doses of rocatinlimab against a placebo. The high dose, which matched the dose used in an earlier phase 3 trial, showed a placebo-adjusted EASI-75 (75% improvement in eczema area and severity) of 29.5%. The lower dose yielded a placebo-adjusted EASI-75 of 23.4%.

In the Shuttle trial, which enrolled 746 adults and allowed concurrent use of topical corticosteroids or calcineurin inhibitors, rocatinlimab achieved placebo-adjusted EASI-75 results of 28.7% and 30.4% for the low and high doses, respectively.

Comparison to Earlier Data and Dupixent

These latest results appear more promising than those from Amgen's first phase 3 trial reported last year, which showed a placebo-adjusted EASI-75 of 19.1% after 24 weeks. However, analysts note that Dupixent has demonstrated higher efficacy in its trials, with placebo-adjusted EASI-75 figures reaching up to 36% after 16 weeks.

Despite the apparent efficacy gap, Amgen sees an opportunity for rocatinlimab due to its different mechanism of action. The company cites evidence suggesting that patients frequently discontinue or switch therapies, potentially creating a market for alternative treatments.

Future Developments and Additional Studies

Amgen's comprehensive Rocket program for rocatinlimab includes several ongoing trials. The company plans to publish results from the Ascend trial, which assesses dosing beyond 24 weeks, and the adolescent Astro study in the second half of this year. Another adolescent trial, Orbit, is currently underway, along with phase 2 and 3 studies in asthma and prurigo nodularis.

These studies aim to explore rocatinlimab's potential to rebalance the T cell compartment, which could provide a unique therapeutic approach in the treatment of atopic dermatitis and related conditions.