Bimekizumab

Dive Brief:An experimental immune disease drug from Moonlake Immunotherapeutics fell short of investors expectations in a pair of closely watched clinical trials, sending shares of the Swiss biotechnology company falling more than 80% on Monday.Both late-stage trials focused on patients with a chronic inflammatory skin condition known as hidradenitis suppurativa. In one, about 35% of participants treated with the Moonlake's drug, sonelokimab, had a significant reduction in disease symptoms after four months, versus about 18% of placebo recipients. While that result met statistical significance, the difference between the two groups wasnt as large as executives and investors had hoped.Sonelokimab also failed to meet its main objective in the second study, a result the company blamed on a higher than expected placebo response in a statement Sunday. Moonlake aims to discuss the approval path with regulators while the trials continue but, following the results, multiple Wall Street analysts expressed skepticism about a quick clearance as well as the drugs sales potential.Dive Insight:Moonlake had been hoping the study results would prove its medicine is a step forward in treatment for hidradenaitis suppurativa a skin disease that causes painful abscesses and tissue scarring, and that analysts see as a still-untapped opportunity for drugmakers.Sonelokimab binds to two inflammatory cytokines as well as a third protein, albumin, that are involved in the diseases progression. Moonlake has said the way in which the drug gets at those targets, as well as its small molecular size, might help it be more potent and longer lasting than available biologics like AbbVies Humira, UCBs Bimzelx and Novartis Cosentyx.Data leading up to late-stage testing suggested Moonlakes drug had an optimal profile compared to so-called IL-17 inhibitors like Bimzelx and Cosentyx, Leerink Partners analysts wrote in a January report. Moonlake reportedly turned down a buyout offer from Merck & Co. this year, too.Yet sonelokimab didnt demonstrate the kind of clear-cut dose response in mid-stage testing that investors like to see. In the meantime, the 2023 and 2024 approvals of Cosentyx and Bimzelx, respectively, added pressure for the company not just top its placebo comparator in testing, but show sonelokimab might be competitive with, or even superior to those medicines as well.The results disclosed Sunday, described by analysts as disappointing and undifferentiated, all but erased those hopes. The magnitude of the effects observed looks uncompetitive with Bimzelx, likely relegating sonelokimab to a much narrower role while casting doubts on its potential against other diseases, wrote RBC Capital Markets analyst Brian Abrahams.The data have also introduced uncertainty around Moonlakes approval path and commercial outlook, added Leerinks Thomas Smith.In its statement, Moonlake noted how pooled results from both studies demonstrated a clinically meaningful and statistically significant improvement across all trial goals and how, in the test that failed, placebo recipients responded at a much higher rate than history suggested they would. Executives will discuss the results with regulators, including the analytical strategies now necessary given the placebo groups performance.However, a clear path to approval is likely off-the-table in the near term, wrote Stifel analyst Alex Thompson.Moonlakes share price plummeted from about $62 apiece to less than $10 early Monday. '

MoonLake Immunotherapeutics on Saturday announced a mixed bag of results from two pivotal studies investigating its trispecific IL-17A/F Nanobody sonelokimab in hidradenitis suppurativa (HS), with one trial hitting its mark, and the other falling short owing to a placebo response above estimates.The Swiss biotech reported interim week 16 results from its Phase III VELA-1 and VELA-2 trials, which together enrolled 838 patients with moderate-to-severe HS, comparing a single 120-mg subcutaneous dose of sonelokimab to placebo. Results showed VELA-1 met its primary endpoint, demonstrating 34.8% of patients on sonelokimab achieved HiSCR75 — a 75% reduction in inflammatory lesions — compared with 17.5% for placebo. Meanwhile, VELA-2 failed to reach statistical significance as per the pre-specified composite analysis strategy, despite showing a 35.9% response rate on HiSCR75 versus 25.6% for placebo. Additionally, sonelokimab met all key secondary endpoints in both studies, including HiSCR50, IHS4-55 and several patient-reported outcomes compared with placebo on the composite strategy."The higher-than-expected placebo response rate in VELA-2 is disappointing but we are encouraged by the consistent performance of sonelokimab arms across all endpoints in both studies," said Kristian Reich, chief scientific officer at MoonLake.MoonLake, however, noted that upon analysis by an alternative pre-specified treatment policy approach, the sonelokimab arms in both studies achieved statistically significant gains across all primary and key secondary endpoints against placebo.Safety-wise, sonelokimab's profile was consistent with previous studies, with no new signals recorded for events of interest associated with IL-17A and F therapies, including suicidal ideation, hepatic events, inflammatory bowel disease, and major adverse cardiovascular events. Nasopharyngitis, headache, and upper respiratory tract infections were the common adverse events, with oral candidiasis occurring at a much higher frequency of 7.3% in sonelokimab recipients compared with placebo’s 0.4%.Eyeing 2027 launchMoonLake is slated to discuss the interim findings with regulators to chart a path forward for filings, while awaiting the 52-week data expected in the second quarter of next year. Armed with a $500 million financing package from Hercules Capital earlier this year, the biotech is aiming for a 2027 launch of the Nanobody in inflammatory conditions. If approved for HS, the trispecific antibody would need to take on UCB’s IL-17A/F inhibitor Bimzelx (bimekizumab), which gained FDA clearance for the same indication last year. Jorge Santos da Silva, chief executive of Moonlake, earlier told FirstWord that sonelokimab’s smaller size conferred it a key advantage over traditional antibodies, enabling faster and deeper tissue penetration. For more, see – ViewPoints: Why MoonLake's CEO sees sonelokimab eclipsing rivals in HS.Intron Health analyst Naresh Chouhan earlier this month said while “the market is fretting about the potential for sonelokimab to become a challenger to Bimzelx,” the perceived threats to UCB might be overstated.Besides the lead indications HS and psoriatic arthritis, MoonLake continues exploring sonelokimab in palmo-plantar pustulosis and axial spondyloarthritis.