Title: Merck's Evobrutinib Mediocre Performance Tanks Stock Value
Investors are shedding Merck KGaA shares like hot potatoes, following Evobrutinib's disappointing show in phase three trials for MS treatment. The once-promising drug, hailed as a potential blockbuster, fell flat, failing to surpass the effectiveness of Sanofi's Aubagio. Consequently, shares plummeted by a grim 13%.
The global head of Merck's Research & Development, Danny Bar-Zohar, expressed the company's collective disappointment. Evobrutinib, a BTK inhibitor, had been the luminary of Merck's pharmaceutical horizons, with CEO Belen Garijo predicting peak sales of billions. Initial trials, however, were halted by the FDA due to liver damage concerns, only to resume following normalization of affected patients' liver values.
Merck's woes don't end here. Evobrutinib's lackluster performance follows a string of failed trials for cancer drug bintrafusp alfa in 2021. These series of setbacks mark Merck's first drug launch since Bavencio in 2017.
Other DAX board members may reassess their strategies within the pharmaceutical sector in light of Merck's setbacks.
Insight
Evobrutinib demonstrated its efficacy in relapsing MS patients, but its results failed to surpass those of approved drugs. The trial reported no significant increase in adverse events compared to existing therapies, except for transient liver enzyme elevations.
Insights
The assessments and perspectives for BTK inhibitors in MS treatment, including Merck's Evobrutinib and its performance relative to existing drugs like Aubagio, are covered as follows:
Merck's Evobrutinib
- Phase III Trial Failure: In December 2023, Evobrutinib's clinical trial outcomes fell short of its primary objectives. While it demonstrated potential in slowing down MS progression, it didn't significantly outperform Teriflunomide (Aubagio) in preventing relapses or disease progression[3][5].
- Lack of Superiority: Evobrutinib did not prove superior in preventing relapses or disease progression for MS patients compared to Teriflunomide[3].
Sanofi's Tolebrutinib
- Positive Results: The HERCULES study reported that Tolebrutinib, a BTK inhibitor from Sanofi, substantially slowed disability progression in non-relapsing secondary progressive MS (nrSPMS). The study showed Tolebrutinib delayed the onset of 6-month relapsed disability progression by 31% compared to placebo[1][3].
- Disparate Performance: In relapsing-remitting MS, Tolebrutinib was not noticeably different from Teriflunomide in terms of annual relapse rate. However, it demonstrated a significant edge in preventing disability progression, a critical secondary endpoint[3].
- Future Expectations: Preliminary outcomes from the ongoing PERSEUS phase 3 trial of Tolebrutinib in primary progressive MS (PPMS) are expected in the second half of 2025. This study will examine Tolebrutinib's efficacy in delaying disability progression in PPMS, comparing it to placebo[1][3].
These findings underscore the quest for efficient MS treatments, with Tolebrutinib emerging as a promising BTK inhibitor despite its limitations compared to existing therapies like Aubagio.
