Sonelokimab

MIAMI — MoonLake Immunotherapeutics is expected to have one of the biotech industry’s biggest stock-moving clinical readouts around the middle of this year for a pair of Phase 3 trials in a painful inflammatory skin condition. The Swiss biotech’s CEO, Jorge Santos da Silva, spoke with Endpoints News on the sidelines of this week’s Leerink Partners healthcare conference in Miami to discuss the upcoming readout, plans for commercializing solo and squashing the Street’s “conspiracy theories.” Da Silva said there’s been “a lot of M&A noise” around the company, but he’s not planning for that, and he’s confident MoonLake can commercialize its anti-IL-17A/F nanobody on its own. The company was reported to have been exploring a sale in 2023. Known as sonelokimab, the candidate is being tested in Phase 3 for hidradenitis suppurativa, in which patients have abscesses, nodules and draining tunnels. “As a CEO, I would never plan for anything other than making the company grow over the years,” da Silva said. “I would never, and I will never and have never managed the company for anything like that. We’re building the commercial structure.” The company will report data from about 800 patients across two similar pivotal trials in HS this summer. It’s also being explored for other indications. It’s a ripe moment for the space. Novartis markets Cosentyx, UCB recently gained approval for Bimzelx in HS and other molecules are in development. After its looming efficacy data readout, MoonLake will have to wait until next year for longer-term safety data, and by that point, it should also have late-stage data from a trial in adolescents, da Silva said. It could launch the treatment in 2027 if approved, he added. TD Cowen analysts earlier this week projected more than $4 billion in peak sales for sonelokimab. “In the next two or three years, we could really start changing the narrative around this horrible disease,” da Silva said. MoonLake enrolled its two Phase 3 trials rapidly, at about “double the speed of what pharma typically does in this space,” the CEO said. The trials have identical protocols and geographies, but the clinical sites are different. He said he expects one of the trials to gather data in July and the other within a couple of weeks of that, but the company will report both at the same time. “MoonLake has always had a very big short position, and the short has always been very vocal for obvious reasons, and there is one of these conspiracy theories that we’re too aggressive and that we won’t deliver on the trial,” da Silva said. The company will have a capital markets update in the second quarter in which they’ll disclose the exact timing of the readouts and a “couple of other cool messages” that he declined to elaborate on. MoonLake will also open a US office early next year, but he declined to disclose which city. “I expect the capital markets update to quench one of these last conspiracy theories,” da Silva said, referring to the ability to replicate mid-stage results. If MoonLake’s results are positive, the company could tap additional funding. “Obviously tapping the equity markets on the readout I think that’s a no-brainer,” he said. The company’s shares $MLTX are down about 28% year-to-date. It carries a market capitalization of about $2.4 billion. MoonLake went public via a combination with Bihua Chen’s special purpose acquisition company a few years ago. Chen’s second SPAC announced late last month it will take BridgeBio Oncology Therapeutics onto the Nasdaq. “I don’t know if SPACs are still the bastard sons of biotech, but I think as we’ve shown — and a couple of others have shown, I agree not many —  I don’t think it matters if it’s a SPAC or not,” da Silva said. “It matters that you have a proper team that reports well so that after two or three quarters, people go, ‘OK, these guys are not doing something crazy here.’ And then the data, right? I really like BBOT. I think it could be interesting. And obviously, I’m a big fan of Bihua and her ability to choose good things.”

UCB's Bimzelx (bimekizumab-bkzx) is proving to be a key player in psoriasis and hidradenitis suppurativa (HS), with new longer-term data presented at the American Academy of Dermatology (AAD) conference Friday likely to give its commercial momentum a bit more spark.The dual IL-17A/F inhibitor's success has been driving major sales growth for the Belgian drugmaker, skyrocketing from $154 million in 2023 to $632 million last year, blowing past consensus (see – Spotlight On: UCB's Bimzelx delivers strong growth on back of US approvals). In a recent note, Morningstar analysts said Bimzelx was on track to hit blockbuster status and generate over €1 billion ($1.1 billion) in sales in 2025.'New standard' for successIn a new analysis from the second extension of the Phase III BE BRIGHT study, UCB said 67.7% of patients with moderate-to-severe plaque psoriasis maintained complete skin clearance (PASI 100) at the five-year mark. The analysis, which looked at 153 patients who completed the extension period, also showed that 84.9% achieved near-complete clearance (PASI 90) over that five-year span.Additionally, roughly 70% of patients at risk for developing psoriatic arthritis saw their skin completely clear up with Bimzelx treatment at three years, close to the 72% rate seen in the overall treated group. The drug's long-term safety profile also remained consistent with previous findings, with nasopharyngitis, oral candidiasis, and upper respiratory tract infections being the most common adverse events.Fiona du Monceau, head of patient evidence at UCB, said the company is aiming to set "a new standard for treatment success."Bimzelx was first approved in the US in 2023 for plaque psoriasis, and racked up three more indications — psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis — last September.It scored its fifth and most recent approval two months later, when the FDA greenlit the drug for HS based on results from the Phase III BE HEARD I and II studies. Two-year data from the extension trial presented at AAD showed sustained disease control with Bimzelx, as well as the potential to help prevent long-term structural damage caused by draining tunnels (DTs), which are painful "passageways" that can form under the skin that drain pus and blood.UCB said 55.7% of patients with baseline DTs were tunnel-free at two years of treatment. Even in patients with five or more DTs at baseline, 41.1% had none after two years of therapy. Treatment also provided meaningful relief from disease-associated skin pain, with 63.6% of patients reporting no or mild skin pain at two years compared to just 10% at baseline.According to Jefferies analysts, Bimzelx revenues could accelerate further in 2025 given the drug's differentiated profile versus competitors in psoriatic arthritis and HS. Following its approval in HS late last year, a FirstWord poll of 29 dermatologists found that over a third expected Bimzelx to become a frequently used treatment option that is used preferentially over other therapies (see – Physician Views Results: Many dermatologists keen to embrace Bimzelx for HS).Rival readoutsHowever, competition in the HS space is intensifying. In a recent note, Morgan Stanley analysts said "competitive developments could become increasingly in focus" with several late-stage candidates expected to report data. These include MoonLake's Immunotherapeutics' IL-17A/IL-17F nanobody sonelokimab, Incyte's oral JAK inhibitor povorcitinib, and AbbVie's IL-1A/ IL-1B antibody lutikizumab.Phase III data for sonelokimab and povorcitinib are due this half, while a readout for lutikizumab is expected in 2026. Meanwhile, Eli Lilly plans to reveal further Phase IIb results for a subcutaneous formulation of its CXCR1/2 monoclonal antibody eltrekibart this year. For more, see – Spotlight On: How emerging agents could reshape the HS treatment landscape.