In an investor update on Tuesday, Amgen Inc. (NASDAQ: AMGN) provided data from Phase 3 trials of its drugs Rocatinlimab and Uplizna (inebilizumab).
The HORIZON Phase 3 trial evaluated Rocatinlimab for atopic dermatitis (eczema) involving 726 patients. The results indicated that Rocatinlimab significantly outperformed placebo in terms of disease severity and extent:
EASI-75 Response: 32.8% of patients treated with Rocatinlimab achieved this response at week 24, compared to 13.7% in the placebo group.
vIGA-AD 0/1 Response: 19.3% of Rocatinlimab-treated patients achieved this response at week 24, versus 6.6% for placebo.
rIGA 0/1 Response: 16.4% of Rocatinlimab-treated subjects achieved this at week 24, compared to 4.9% for placebo.
Additionally, the MINT Phase 3 trial for Uplizna in generalized myasthenia gravis demonstrated clinically meaningful and statistically significant improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. After two doses of Uplizna, the adjusted MG-ADL score improved by -4.2, compared to -1.9 for placebo. The trial also showed significant improvement in the Quantitative Myasthenia Gravis (QMG) score, with an overall improvement of -4.8 for Uplizna compared to -2.5 for placebo at week 26. No new safety concerns were identified.
However, while the trials succeeded, STAT News reported that the therapies did not surpass existing market competitors. For example, 51% of adults treated with Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc.’s (NASDAQ: REGN) Dupixent (dupilumab) achieved an EASI-75 response at week 16 in the SOLO 1 trial, compared to 15% for placebo, and 44% versus 12% in the SOLO 2 trial.
William Blair noted that Rocatinlimab’s data fell short of expectations, raising concerns about its competitive positioning in the atopic dermatitis market, especially as the broader ROCKET program progresses. In contrast, the Uplizna results for myasthenia gravis exceeded expectations, highlighting its strong market potential due to its less frequent dosing and ability to reduce steroid use.
Going forward, attention will focus on determining Uplizna’s place in the myasthenia gravis treatment landscape, alongside other options like FcRn, IVIg, and complement inhibitors. The potential for Uplizna’s CD19-targeting strategy in autoimmune diseases will also be monitored closely, especially with competition from companies like Cullinan Therapeutics, Inc. (NASDAQ: CGEM).
As of the latest update, AMGN stock is down 2.09% at $324.04.