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UPDATE: MoonLake hopes another phase 2 win helps IL-17 drug shine brighter in inflammatory race

2023-11-06

临床2期临床结果并购免疫疗法

MoonLake Immunotherapeutics' arthritis readout follows a successful phase 2 trial for sonelokimab in another skin condition called hidradenitis suppurativa.

MoonLake Immunotherapeutics iarthritisto maintain its position as a key player in the sonelokimab an IL-17 inhibitor to market for hidradenitis suppurativaions courtesy of another phase 2 readout the biotech touted as a success.

MoonLake Immunotherapeuticsody, called sonelokimab, was able to induce a statistically significant reIL-17 inhibitor IL-17e in patients with active psoriatic arthritis compared to placebo. A total of 46% of patients who received the 60-mg dose and 47% of those who received the 120-mg dose saw a 50% or greater reduction in signs and symptoms of disease activity at Week 12, hitting the trial’s primary endpoint.

These figures covered patients whose trsonelokimabolved an initial induction period, MoonLake pointed out. “As expected, the active psoriatic arthritison did not reach statistical significance, confirming the 60 mg and 120 mg with induction as the potential dose regimens to carry forward into phase 3,” the biotech said in the Nov. 5 release.

Across the 207-patient ARGO trial, sonelokimab also achieved all its secondary endpoints, including a 90% or greater improvement from baseline on the Psoriasis Area and Severity Index score for both doses with induction.

AbbVie’s psoriasis blockbuster Humisonelokimab as an active reference in the trial, and, while the study was not powered for statistical comparison, MPsoriasislaimed that both doses of sonelokimab “numerically outperformed” the arthritis mainstay on the primary endpoint and all key secondary endpoints. These data “further support the potential for sonelokimab as a future leading therapy,” the biotech argued.

AbbVieighpsoriasisnce of soneloHumiraand its favorable safety profile continue to support the potential of using a smaller biologic with albumin-bindMoonLakecity to inhibit IL-17A and Isonelokimabhe treatment of inflammatory disarthritishe Zurich-based company added.sonelokimab

However, on an R&D call tsonelokimab to discuss the results, a couple of attendees questioned the high ratio of patients in the placebo group, at 20%, who still reported a 5IL-17AuctioIL-17Fymptoms. Some of the pinflammatory diseasest would be on other background medication that could have caused a response, Chief Scientific Officer Kristien Reich explained on the call.

“If we actually look at those patients ‘on placebo’ that have a response, these eight patients … were on pretty high background doses of methotrexate and some of them were on additional corticosteroids,” he said.

“We think this is explainable; this is something that has been seen in other [psoriatic arthritis] trials,” Reich added. “And it means, amethotrexatehe most solid comparisons are to an active reference arm.”

Investors didn't seem convinced, however, sending MoonLake's stock down 30% topsoriatic arthritismarket trading on Monday morning.

Yesterday’s readout follows a successful phase 2 tMoonLake sonelokimab in another skin condition called hidradenitis suppurativa (HS), which sent the Swiss biotech’s stock rocketing 62% in June to around $50 per share, a region it had remained at—until this morning.

The HS trial in June came just days after Eli Lilly handed sonelokimabillion upfront to acquire Dice Thehidradenitis suppurativa (HS) of why IL-17 remains a hot R&D target at the moment.

MoonLake CEO Jorge Santos da Silva, Ph.D.,Eli Lillyhe ARGO readout yesterday as a “landmark mileDice Therapeuticsd “the first trial in psoriaIL-17rthritis using a nanobody.”

MoonLake our hidradenitis suppurativa program, the preparation of our phase 3 program in PsA is rapidly advancing and expected timing opsoriatic arthritisgulatory meetings will be announced in due course,” da Silva added in the release.

Jefferies anahidradenitis suppurativaggested that the failure of Acelyrin’s IL-17A inhibiPsA izokibep to beat placebo in a phase 2b/3 trial in severe HS in September had opened up a space for sonelokimab.

“Due to this competitive landscape change, we now project [sonelokimab] to rIL-17A inhibitor IL-17Aeak penetraizokibep35% in the U.S. (from 32.5%) and 15% in the EU (from 12.5%), both in post-TNF HS patients isonelokimabe analysts said in a September note.

Editor's note: This story was updated at 11.20 a.m. ET on Msonelokimabmber 6, 2023, to include information from MoonLake's R&D call.post-TNF HS