MoonLake Immunotherapeutics’ targeted therapy, sonelokimab, has offered long-term disease-modifying and quality of life (QoL)-boosting benefits during two Phase III hidradenitis suppurativa (HS) studies.
This is evidenced by the data collected from the VELA-1 and VELA-2 clinical trials (NCT06411899; NCT06411379), which both found that 62% of patients treated with sonelokimab achieved HS clinical response 75 (HiSCR75) at week 40, while 32% achieved HiSCR100.
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Sonelokimab also prompted inflammatory remission in 25% of patients who received the drug, which MoonLake defined as a complete clearance of abscesses, nodules, and draining tunnels.
Alongside its efficacy in diminishing HS symptoms, sonelokimab boosted patient quality of life (QoL) from baseline versus placebo at the 40-week mark, with improvements in pain (41%), walking and getting dressed (54%) and mental wellbeing (62%) all observed.
Researchers also proved that long-term treatment with the nanobody-based therapy is safe and tolerable within the HS patient population, with no new safety signals observed in either trial to date.
The VELA programme is ongoing and will continue to explore the efficacy and safety of the interleukin-17A/17F nanobody over a 52-week period. MoonLake expects to debut the 52-week data from this study in Q2 2026. The 40-week data from VELA-1 and 2 were first presented at the 2026 American Academy of Dermatology (AAD) annual meeting on 28 March.
Investors unsure on sonelokimab’s commercial potential
While the results obtained in the VELA programme are largely positive, the initial readout was met with a chilly response from investors, as MoonLake’s stock value crashed 88% after the results debuted. This was due to the drug’s failure to best UCB’s Bimzelx (bimekizumab) in terms of efficacy at week 16.
In previous conversation with Clinical Trials Arena, GlobalData neurology and immunology director, Erela Dana noted that durability of effect was defined as the primary driver of a drug becoming the new blockbuster/lead therapy in HS by key opinion leaders.
However, dermatologists told investor bank Cantor Fitzgerald that long-term data for sonelokimab is at least comparable to Bimzelx, and could be favourable at week 52.
MoonLake will file for sonelokimab’s approval in HS in the second half of 2026, which could see the therapy join a market which GlobalData estimates will be worth $7.8bn by 2034.
GlobalData is the parent company of Clinical Trials Arena.
The biotech is also hoping to commercialise sonelokimab in several other indications, including psoriatic arthritis (PsA), palmoplantar pustulosis, psoriasis and axial spondyloarthritis.
MoonLake expects the Phase III IZAR-1 and IZAR-2 trials (NCT06641076; NCT06641089) in PsA to read out in 2026.
Addressing unmet needs in HS
While several targeted therapies are available to patients with HS, there are still notable unmet needs within this patient population.
According to Alexa Kimball, professor of dermatology at Harvard’s Medical School, long-term disease control is one of the key treatment gaps in HS. “The consistency of the VELA data over time reinforces the opportunity for sonelokimab to address this important unmet need,” Kimball said.
As per GlobalData’s Pharmaceutical Intelligence Center, there are 57 ongoing clinical trials in Phase I to III evaluating either singular or combination therapies for HS, with 17 of these in Phase III.
