Secukinumab

Looking to redeem its IL-17A/F nanobody after a mixed showing in hidradenitis suppurativa (HS) last year, MoonLake Immunotherapeutics unveiled Phase II data Monday for sonelokimab that it believes could change the treatment paradigm in axial spondyloarthritis (axSpA). The 12-week S-OLARIS study enrolled patients with both the radiographic and non-radiographic forms of the chronic inflammatory spine disease. According to topline results, 81% of treated patients (n=26) achieved at least a 40% improvement on Assessment of Spondyloarthritis International Society (ASAS40) criteria at 12 weeks, a standard benchmark for the latest approved therapies in axSpA, the company noted. More than 80% also recorded a "clinically important improvement" on the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) scale. Additionally, PET imaging collected as part of the trial showed a significant reduction in inflammation and osteoblast activity in affected sacroiliac joints, a key driver of irreversible ossification in axSpA, while peripheral blood and tissue biomarker analyses indicated "rapid and sustained effects" at inhibiting immune pathways known to drive inflammation and ossification, the company said. "The complementary data from clinical outcomes, MRI and PET imaging as well as peripheral blood and tissue biomarkers confirm our hypothesis of [sonelokimab's] ability to access deeper tissue, which is essential to optimally control this chronic rheumatological condition and prevent irreversible mobility restriction," said Chief Scientific Officer Kristian Reich. "With millions of patients affected by this devastating condition and limited impact of current therapies in improving relevant disease mechanisms, [sonelokimab] has the potential to change the treatment paradigm." The drug's safety profile in S-OLARISwas consistent with prior trials, with no new signals reported. Monday's readout adds to a growing, if mixed, dataset for sonelokimab. Last year, the Phase III VELA-1 and VELA-2 trials in hidradenitis suppurativa (HS) yielded split interim 16-week outcomes, with VELA-1 meeting its primary endpoint, but VELA-2 falling short owing to a higher-than-expected placebo response. Those datasets sent MoonLake shares crashing as much as 87% at the time, and also removed a potential headwind for rival IL-17 inhibitors such as UCB's Bimzelx (bimekizumab) and Novartis' Cosentyx (secukinumab). See – Spotlight On: MoonLake's big Phase III reveals for sonelokimab not so picturesque. Fifty-two-week data from VELA-1 and VELA-2 are due next quarter, with a regulatory submission in HS planned for the second half. MoonLake is also expecting a primary endpoint readout from the Phase III IZAR-1 trial in psoriatic arthritis by mid-2026, and from the Phase III IZAR-2 trial in the second half of the year. The content above comes from the network. if any infringement, please contact us to modify.

MoonLake Immunotherapeutics’ only investigational drug showed a clinically meaningful benefit in patients with an aggressive form of inflammatory arthritis, according to Phase 2 data the company shared with Endpoints News on Sunday. While that news is positive, investors are more focused on whether the product, a nanobody called sonelokimab that blocks IL-17A and F, can gain approval in hidradenitis suppurativa (HS), a painful and disfiguring skin condition. Last year, one of the two pivotal trials in the disease failed , causing an 89% drop in MoonLake’s stock $MLTX . But the company has decided to seek FDA approval in HS anyway, and plans to file its application in September. “What gives us a lot of confidence,” MoonLake CEO Jorge Santos da Silva told Endpoints, “is really the engagement and the conversations that we’ve had with the FDA since the primary endpoint readout of the Phase 3s.” He described the filing timelines in HS as “all but back on track.” The filing will include data from the Phase 3 VELA-1 and -2 trials, the second of which failed due to unexpectedly high placebo group response. A Phase 2 study of sonelokimab in HS, called MIRA, will also form part of the filing. “We will take MIRA and VELA-1 to establish what the FDA calls substantial evidence of effectiveness,” Santos da Silva said. Data from VELA-2 will be used to help back sonelokimab’s safety, he added. It is possible that sonelokimab will gain approval despite the one study’s failure. Novartis’s anti-IL-17A antibody Cosentyx, for example, was approved for the disease even though it missed the primary endpoint of one of its pivotal trials. If sonelokimab is approved in HS, it will compete with UCB’s Bimzelx, the only approved IL-17A and F inhibitor for the condition. But Bimzelx’s label carries warnings of suicidal ideation and behavior, infections including tuberculosis, and liver abnormalities, among others. If sonelokimab can avoid similar warnings, it could have an advantage. “We did not see any suicidal ideation and behavior cases” in trials of sonelokimab, Santos da Silva said. “We do not have any liver signal. We do not have any TB.” But he said it’s possible, if unlikely, that the FDA would be cautious and put these warnings on sonelokimab’s label too, since it shares a mechanism with Bimzelx. The “dream scenario” — no such warnings — is more probable, he said. “Between the various efficacy scenarios, the various safety scenarios, the convenience and the fact that these markets are wide open, I think there’s a good chance that we make a buck,” Santos da Silva said. The company also disclosed Phase 2 data on Sunday in a condition called axial spondyloarthritis. It causes chronic inflammatory back pain, and later can lead to progressive bone formation, fusing patients’ joints and severely limiting spinal mobility. In the trial, called S-OLARIS, 26 patients were given sonelokimab, and 81% of them hit a specific benchmark for improvement in disease activity, pain, physical function and inflammation. That goal, called ASAS40, was assessed after three months of treatment. There was no placebo group. MoonLake also said that more than 80% of patients in the study had “clinically important improvement,” as measured by imaging to assess inflammation and injury in the bone where the spine meets the pelvis. More details on sonelokimab’s performance in the condition and the drug’s future in HS are expected during MoonLake’s investor day on Monday. The Zug, Switzerland-based biotech has enough cash to last until the second half of 2027, it said on Sunday. It has also amended a debt facility with Hercules Capital, with a concurrent drawdown of $25 million and up to $400 million in non-dilutive funds still available.