Medical Innovation Exchange

MoonLake shines brighter as IL-17 drug scores another phase 2 win in inflammatory race

MoonLake Immunotherapeutics has maintained its position as a key player in the race to get an IL-17 inhibitor to market for inflammatory skin conditions courtesy of another successful phase 2 readout.

The trivalent camelid nanobody, called sonelokimab, was able to induce a statistically significant response 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 treatment involved an initial induction period, MoonLake pointed out. “As expected, the 60 mg dose without induction 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 Humira was used as an active reference in the trial, and, while the study was not powered for statistical comparison, MoonLake said 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 concluded.

“The high performance of sonelokimab and its favorable safety profile continue to support the potential of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases,” the Zurich-based company added.

Yesterday’s readout follows a successful phase 2 trial for 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 has settled into comfortably since then.

That HS trial came just days after Eli Lilly handed over $2.4 billion upfront to acquire Dice Therapeutics in another reminder of why IL-17 remains a hot R&D target at the moment.

MoonLake CEO Jorge Santos da Silva, Ph.D., hailed the ARGO readout as a “landmark milestone” that marked “the first trial in psoriatic arthritis using a nanobody.”

“As with our hidradenitis suppurativa program, the preparation of our phase 3 program in PsA is rapidly advancing and expected timing of end-of-phase 2 regulatory meetings will be announced in due course,” da Silva added in the release.

Jefferies analysts have previously suggested that the failure of Acelyrin’s IL-17A inhibitor 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 reach peak penetration of 35% in the U.S. (from 32.5%) and 15% in the EU (from 12.5%), both in post-TNF HS patients in 2035,” the analysts said in a September note.

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