Amgen Inc (AMGN) shared encouraging results from its Phase 3 clinical trials for two promising treatments: rocatinlimab for atopic dermatitis (eczema) and Uplizna (inebilizumab) for generalized myasthenia gravis.
The HORIZON Phase 3 trial for rocatinlimab involved 726 patients and demonstrated a significant improvement in the severity and extent of eczema compared to a placebo. Notably, 32.8% of patients treated with rocatinlimab achieved a significant reduction in eczema symptoms (EASI-75) at week 24, compared to only 13.7% of those receiving a placebo. Similar positive results were observed in other measures of eczema improvement.
However, while rocatinlimab showed promise, it didn’t quite surpass existing competitors like Sanofi SA (SNY) and Regeneron Pharmaceuticals Inc’s (REGN) Dupixent (dupilumab). Dupixent achieved a higher rate of EASI-75 response in its SOLO 1 and SOLO 2 trials, leading analysts to express some concern about rocatinlimab’s competitive edge in the increasingly crowded atopic dermatitis market.
On a brighter note, the MINT Phase 3 trial for Uplizna in generalized myasthenia gravis exceeded expectations. The trial demonstrated a clinically meaningful and statistically significant improvement in the MG-ADL score, a measure of the severity of myasthenia gravis symptoms. After two doses of Uplizna, patients showed an overall improvement of -4.2 in their MG-ADL score compared to -1.9 for those receiving a placebo. The trial also showed a significant improvement in the QMG score, another clinical assessment of myasthenia gravis severity.
Analysts believe Uplizna’s less frequent dosing and potential to reduce steroid use could make it a strong contender in the myasthenia gravis treatment landscape, alongside other therapies like FcRn, IVIg, complement inhibitors, rituximab, and more. The unique CD19-targeting strategy employed by Uplizna in treating autoimmune diseases is also drawing significant attention, especially with competitors like Cullinan Therapeutics, Inc. (CGEM) developing similar approaches.
Overall, Amgen’s latest clinical trial results are a mixed bag. While rocatinlimab’s performance fell short of expectations in the atopic dermatitis market, Uplizna’s success in treating myasthenia gravis has generated considerable excitement. The future holds significant potential for both treatments, and the medical community will be closely watching their progress in the coming years.
