MoonLake’s PhII data on skin disease set it up against Cosentyx, UCB and others in IL-17 field

MoonLake Immunotherapeutics says it’s cleared the bar in a Phase II trial of its IL-17A and IL-17F inhibitor in hidradenitis suppurativa.

In its 234-patient MIRA study, MoonLake said it succeeded on the primary goal — more patients on its investigational med sonelokimab achieved at least a 75% reduction from baseline in total abscess and inflammatory nodule count than those on placebo. People with HS experience recurring nodules and abscesses in the armpits, groin and buttocks, and sinus tracts. It leads to pain and sometimes stigmatization.

MoonLake touted a p-value of 0.0002 at week 12, noting a 29-point percentage difference versus placebo. In a press release, MoonLake claimed it’s the first randomized clinical trial to use the score — Hidradenitis Suppurativa Clinical Response 75, or HiSCR75 — as the primary endpoint. Other drugmakers have used a 50% reduction, or HiSCR50, to evaluate their biologics. On that measure, MoonLake recorded a p-value less than 0.0001. Patients on sonelokimab also reported better quality of life outcomes and lower pain than those on placebo.

The data add to the momentum in the IL-17 field’s pursuit to treat the chronic inflammatory skin disease. Novartis gained EU approval this month for Cosentyx in HS; UCB’s bimekizumab is headed to regulators next quarter; Eli Lilly made a $2.4 billion bet on DICE’s DC-806 and DC-853; and Acelyrin reeled in a massive IPO last month ahead of a Phase IIb/III readout next quarter for izokibep. Outside of IL-17, Incyte has a JAK1 for HS in Phase III.

Jorge Santos da Silva

For MoonLake, the data readout is a pivotal moment and could set it up for Phase III studies in the second quarter of 2024, CEO Jorge Santos da Silva told Endpoints News. The biotech landed on the Nasdaq via a blank-check merger last April, and its shares $MLTX have steadily risen since then. It’s one of a handful of biotechs to experience an overall uptick in share price after going public with a SPAC.

Ahead of the readout, TD Cowen analysts predicted a win on the primary goal, and Jefferies analyst Kelly Shi said a result similar to UCB’s “is a winning case.”

“MLTX suggests that the ‘bar’ for the results from the MIRA trial should be >20% placebo-adjusted HiSCR75 rate. Based on our conversations, it is our sense that investor expectations are a bit more aggressive and that investors anticipate SLK will produce a placebo-adjusted HiSCR75 rate between those produced in bimekizumab’s Ph. II (~35%) and its Ph. III trials (~22%),” TD Cowen analyst Phil Nadeau wrote in a June 6 note.

Kristian Reich

“The feedback that we are getting from the KOLs, this is not an incremental improvement,” science chief Kristian Reich said in a joint interview with da Silva. “This is one of these rare moments in clinical development where you see something that is fundamentally better. Of course, this all needs to be replicated in Phase III.”

The company said sonelokimab had a “favorable safety profile, in line with the known profile of IL-17 inhibitors.” The US and European trial included four groups: one on 240 mg of sonelokimab; another on 120 mg; a placebo arm that transitioned to either of the two active group dosages at week 12; and a smaller set that began with adalimumab (known widely as Humira) that transitioned to 240 mg of sonelokimab at week 12.

The 120 mg dose was the “winner,” da Silva said. As of now, the biotech plans to conduct two Phase III trials with about 600 to 700 patients, he said. It still needs to hash out study plans with the FDA. Decisions are up in the air on whether to include a superiority analysis against Humira and whether the Phase II could count toward the registration package, the CEO added.

Many in the IL-17 class are inhibitors of interleukin 17A, a cytokine that drives inflammation. Like UCB, MoonLake also goes after IL-17F. UCB reported Phase III data earlier this year and said it will ask for an expanded label of its monoclonal antibody, which is approved in Europe as Bimzelx for plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.

MoonLake seeks to differentiate itself by creating a smaller molecule, known as a nanobody, that also binds to albumin, a liver-produced protein.

MoonLake said it will share more data in a peer-reviewed medical journal. The biotech also plans to share primary endpoint data for another Phase II study, testing it in patients with active psoriatic arthritis, in the fourth quarter. The nanobody had also been tested in a Phase IIb trial in patients with moderate-to-severe plaque-like psoriasis.

Last month, the biotech disclosed a collaboration with SHL Medical to make an autoinjector for clinical and potential commercial supply of sonelokimab, MoonLake’s sole asset.

The company plans to keep developing the molecule on its own.

“Licensing is the last thing we have in our minds,” da Silva said, citing the potential for sonelokimab in multiple indications. “We want to make sure we continue focusing on this development and it doesn’t get lost in complicated structures.”

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