MoonLake Immunotherapeutics will advance its IL-17 inhibitor into a Phase III programme following positive feedback from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).  

The trivalent camelid nanobody, called sonelokimab (M-1095), is indicated for the treatment of hidradenitis suppurativa – a chronic skin condition causing painful lumps and abscesses in areas where skin rubs together, like the armpits and groin.  

The Phase III VELA programme will evaluate sonelokimab’s effectiveness by comparing a single 120mg dose of the nanobody to placebo over 16 weeks. After this period, the placebo group will switch to sonelokimab. The trial will run for 52 weeks followed by an open-label extension study. The primary endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) 75, measures a ≥75% reduction in abscesses and inflammatory nodules without an increase in abscess or draining tunnel count against the baseline. 

The trial, enrolling 800 patients, aims to support a biologics license application and an EU marketing authorisation application, according to MoonLake.  

IL-17 inhibitors are drugs that are designed to specifically target immune cells. IL-17 is proven to be implicated in inflammatory autoimmune conditions. In October 2023, the FDA approved the first IL-17A and IL-17F inhibitor for patients with moderate to severe plaque psoriasis, UCB’s BIMZELX (bimekizumab). 

In June 2023, MoonLake released topline data from its Phase II MIRA trial (NCT05322473), revealing that 46% of patients receiving the 60 mg dose and 47% of those on the 120 mg dose achieved a 50% or greater reduction in disease activity symptoms by week 12, hitting the trial’s primary endpoint. 

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MoonLake is also investigating the candidate in trials for psoriatic arthritis, and plans to initiate Phase III trials in April 2024, following an end-of-Phase II meeting with the FDA scheduled for Q2 2024. 

According to GlobalData’s Pharma Intelligence Center, a sales consensus forecasts sonelokimab to have global sales of $949m by 2029. 

GlobalData is the parent company of Pharmaceutical Technology. 

In the announcement about the regulators’ decisions, CEO of MoonLake Jorge Santos da Silva said: “The favourable response from both the FDA and EMA aligns with the strengths we have consistently highlighted in our trial programs and outlines a clear regulatory path for sonelokimab in hidradenitis suppurativa.”