In an investor update on Tuesday, Amgen Inc (NASDAQ:AMGN) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab).
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) in 726 patients.
Amgen reported that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
- 32.8% of rocatinlimab-treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo.
- 19.3% of rocatinlimab-treated subjects achieved a vIGA-AD 0/1 response at week 24 vs. 6.6% placebo.
- 16.4% of rocatinlimab-treated subjects achieved a rIGA 0/1 response at week 24 vs. 4.9% placebo.
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MINT Phase 3 trial of Uplizna in generalized myasthenia gravis showed a clinically meaningful and statistically significant MG-ADL (Myasthenia Gravis Activities of Daily Living) score, a measure of the severity of myasthenia gravis symptoms.
After two doses of Uplizna, MG-ADL score showed an overall improvement of -4.2, versus -1.9 placebo adjusted.
The trial demonstrated a statistically significant improvement in the Quantitative Myasthenia Gravis (QMG) score, a clinical assessment that measures the severity of myasthenia gravis.
QMG score improvement with Uplizna compared to placebo at week 26 was -4.8 overall improvement compared to -2.5 placebo adjusted.
No new safety signals were identified.
STAT News noted that though the trials succeeded, the therapies did not beat existing competitors on the market.
51% of adults treated with Sanofi SA (NASDAQ:SNY)/ Regeneraon Pharmaceuticals Inc's (NASDAQ:REGN) Dupixent (dupilumab) achieved EASI-75 vs. 15% with placebo at Week 16 in SOLO 1 trial and 44% vs. 12% in SOLO 2 trial.
William Blair noted that rocatinlimab's data fell short of expectations, raising concerns about how its clinical profile stacks up in the increasingly competitive atopic dermatitis market, particularly as the broader ROCKET program unfolds.
On the other hand, the Uplizna results for myasthenia gravis exceeded William Blair's expectations, indicating a strong market potential for the treatment. Key advantages include its less frequent dosing and potential to reduce steroid use.
The focus will be determining Uplizna's position within the myasthenia gravis treatment landscape alongside other options like FcRn, IVIg, complement inhibitors, rituximab, and more. Additionally, the potential for Uplizna's CD19-targeting strategy in autoimmune diseases will be closely watched, especially with competitors like Cullinan Therapeutics, Inc. (NASDAQ:CGEM).
Price Action: AMGN stock is trading lower by 2.09% to $324.04 at the last check on Wednesday.
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