Thursday witnessed a noticeable shift in the pharmaceutical stock market, as revelations about a recent drug trial had contrasting impacts on the shares of two separate entities, Sanofi and Nektar Therapeutics (NKTR). This change was largely due to the general opinion that Sanofi’s latest findings lacked the anticipated robustness, while driving optimistic projections for Nektar’s ongoing REZPEG Phase 2b REZOLVE-AD. This news provoked a significant jump in Nektar’s stock price, while Regeneron (REGN) shares experienced an upswing, as well.
Sanofi, the global health care leader, publicised its initial findings from the Phase 3 trial of the experimental drug amlitelimab, a candidate in the pipeline for atopic dermatitis treatment. However, the drug’s performance came out as somewhat lackluster, as it was unable to meet the anticipated efficacy benchmarks. Counterintuitively, this did not only impact Sanofi negatively but also served as a catalyst for Nektar’s stock surge.
The ongoing clinical trial, titled as the global COAST 1 phase 3 study, extensively focuses on monitoring the effect of amlitelimab in patients suffering from moderate to severe atopic dermatitis. The drug, a monoclonal antibody that targets the OX40-ligand, showed itself to be beneficial when administered either on a monthly basis or after a span of twelve weeks.
Success was witnessed across all predefined vital and secondary endpoints, depicting a significant positive impact in decreasing the severity of skin diseases as compared to the placebo. The patients, ages twelve and above, exhibited a considerable improvement at the end of the 24-week period. The well-toleration of amlitelimab by the patients, with no new safety concerns raised, acted as an encouraging sign.
Key outcomes were measured at the 24-week mark post the amlitelimab treatment, under two different testing schedules – either every four weeks or every twelve weeks. For U.S. and U.S. reference nations, the primary endpoint incorporated the proportion of patients who showed a marked reduction in their initial scores as per the validated investigator global assessment scale for atopic dermatitis.
Furthermore, both treatment groups exhibited progressively increasing degrees of effectiveness, without any evidence of stagnation throughout the trial period. Notably, the key secondary endpoints were also achieved across both testing arms, by the end of the 24-week phase.
These secondary endpoints encompassed those patients who reported just barely noticeable erythema following a score reduction of two or more, and those who achieved a reduction of four or more points from their baseline peak pruritus-numerical rating scale.
Meanwhile, the most commonly reported adverse events during the COAST 1 clinical trial were encompassed by Atopic Dermatitis, nasopharyngitis and upper respiratory tract infection. These adverse events were predominantly more common within the placebo group. Mild reactions were noted at the injection site in those patients administered amlitelimab, but they recovered and continued to participate in the trial.
Overall, the rates of pyrexia and chills among the tested candidates were low. There weren’t significant differences in the emergence of adverse events, serious negative events, and those leading to discontinuation of treatments between the placebo and amlitelimab groups.
Sanofi’s strategy to further establish amlitelimab’s role in the management of atopic dermatitis spans to the inclusion of the drug in the OCEANA clinical program, along with four other similar Phase 3 studies. These studies are expected to be conducted and concluded within a five-year timeline, with results projected to be released by 2026.
However, the reputable financial services firm, Piper Sandler, opined that Sanofi’s data on amlitelimab’s effect on atopic dermatitis, as published in the Phase 3 COAST 1 trial results, fell short when juxtaposed to the superior efficiency seen in Nektar’s REZPEG Phase 2b REZOLVE-AD. The firm hence advocates the superior and distinctive profile of REZPEG, bolstering its potential as a commercial competitor across inflammatory diseases, and thus showing strong support for Nektar.
The day’s trading saw a tangible impact of these revelations on Sanofi’s and Nektar’s stock prices. Sanofi experienced a close to 9% drop, with shares landing at $45.63 apiece, invariably attributing Nektar with an impressive gain as the stock price soared by roughly 20% to hit $34.10 per share.
The overall trend in stock market shifts suggests investor sentiments swaying towards more promising therapeutic candidates with unique profiles. Observations such as these continue to inspire competition and fuel efforts towards medical breakthroughs in the formative landscape of healthcare and disease treatment.
The post Sanofi’s Atopic Dermatitis Drug Fails to Meet Expectations, Boosts Nektar appeared first on Real News Now.
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