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Novartis’ immunology drug Cosentyx (secukinumab) notched its sixth indication, gaining U.S. approval as a hidradenitis suppurativa (HS) therapy, the drugmaker said this week.

The regulatory OK makes Cosentyx the second biologic on the market to treat HS, behind AbbVie’s Humira, and the only IL-17A inhibitor. The Food and Drug Administration’s decision was based on Phase 3 data in which Cosentyx showed relief from HS symptoms as soon as two weeks into treatment. 

“Cosentyx can offer effective, lasting relief” from the chronic skin disease, stated Victor Bultó, president of Novartis US, giving people with HS “a chance to live every day with confidence.” 

HS, which affects about one in 100 people worldwide, is marked by recurring, boil-like lumps that may burst into open wounds and cause irreversible scarring. Often painful, these lumps usually occur in the intimate parts of the body, from the groin and trunk to the breasts and armpits.

Besides the physical symptoms, the condition carries an emotional component, as well. The effect on quality of life is compounded by the delay in diagnosis, which can take up to a decade.

Cosentyx for HS is approved for monthly administration, with optional two-week dosing. That’s backed by two Phase 3 trials, SUNSHINE and SUNRISE. The primary endpoint in both was a hidradenitis suppurativa clinical response (HiSCR50), defined as at least a 50% decrease in abscess and inflammatory nodule (AN) count with no increase in the number of abscesses and/or draining tunnels. 

A higher proportion of patients given 300 mg of Cosentyx either every two (SUNSHINE) or four weeks (SUNRISE) achieved a higher HiSCR50 versus placebo. Week 16 results showed HiSCR50 of 44.5% versus 29.4% as well as 38.3% versus 26.1%, respectively. 

While Novartis got the FDA greenlight, several other clinical-stage agents are also targeting the disease. 

UCB is testing its own  IL-17A/F inhibitor, bimekizumab. In the drugmaker’s Phase 3 BE HEARD trials, the drug led to a greater proportion of subjects achieving HiSCR50 than placebo at week 16. Some bimekizumab patients also achieved a deeper level of clinical response – HiSCR75, which was a secondary endpoint in the trials.

However, two-year-old biotech MoonLake Immunotherapeutics may have them both beat. It’s pursuing an HS indication for its anti-IL17A/F nanobody sonelokimab, and analysts are touting its class-leading potential. 

Six-month data from MoonLake’s Phase 2 data MIRA trial, in which HiSCR75 was the primary and secondary endpoint, showed a 120 mg dose of sonelokimab met and exceeded investor expectations, along with surpassing bimekizumab’s efficacy in BE HEARD.

The MIRA findings reinforced sonelokimab’s “compelling efficacy/safety profile coupled with an ability to drive class-leading clinical benefit,” wrote Leerink analyst Thomas Smith in an investor note. The Leerink team raised sonelokimab’s chance of success from 70% to 75% and forecast peak revenues of $3 billion, with a projected launch year of 2027.

At last month’s European Academy of Dermatology and Venereology conference in Berlin, where the MIRA results were shared, one researcher reportedly attributed the asset’s performance to its smaller size. He highlighted its ability to drive better tissue penetration relative to larger antibodies, including Humira and Cosentyx, leading to better draining of HS nodules.

Others are having trouble meeting the higher efficacy bar, however. In September Acelyrin reported disappointing topline data for its IL-17AA antibody mimetic izokibep in HS. 

A Phase 2b/3 trial unexpectedly failed to meet the primary endpoint of HiSCR75 at week 16. The biotech chalked up the miss to early responder discontinuations in treatment arms and unexpected placebo outperformance. 

With izokibep now having “an uncertain path forward in this indication,” Acelyrin’s setback “creates additional opportunity” for MoonLake in HS, Smith wrote in an earlier note.