MoonLake Therapeutics’ sonelokimab has posted a potential comeback in hidradenitis suppurativa (HS) following the positive results of a Phase III trial.
The late-stage VELA-TEEN study (NCT06768671), which was investigating the efficacy of sonelokimab in adolescent patients with HS, found that the drug triggered a Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) in 46% of patients at the 16-week mark.
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HiSCR75 is a common clinical outcome measure that quantifies a patient achieving a 75% reduction from baseline in HS-associated inflammatory nodules and abscesses.
More data from the VELA-TEEN trial is expected in 2026.
However, the news is not all positive for sonelokimab, as the drug failed to best UCB’s Bimzelx (bimekizumab-bkz) during the VELA-1 (NCT06411899) and VELA-2 (NCT06411379) trials, which were exploring the drug’s efficacy in adults with HS.
Following the debut of these results, MoonLake’s stocks crashed 88%, dropping from $61.99 to $6.96. The biotech’s stock value has since slowly started to recover, sitting at $10.59 on 5 November market close.
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By GlobalDataDespite this setback, the company is now considering submitting a biologics licence application (BLA) for sonelokimab in the HS indication. In a step to achieve this, the biotech has arranged a Type B meeting for the 15 December 2025 with the US Food and Drug Administration (FDA), which will determine MoonLake’s next moves for the drug.
If sonelokimab were to make it to market, it may play second fiddle to UCB’s Bimzelx, which analysts at GlobalData predict will become a blockbuster seller in 2025, bringing in $1.5bn for the company.
However, Bimzelx is not currently FDA-approved for use in adolescent patients, so MoonLake may be able to capture a portion of this market.
Sonelokimab’s double win
HS is not the only indication in which sonelokimab is being investigated, as MoonLake also reported positive results from the Phase II LEDA study in palmoplantar pustulosis (PPP).
During the mid-stage trial, the drug demonstrated a statistically significant 64% drop in palmoplantar pustular psoriasis area and severity index (PPPASI) scores at week 16. Of the patients enrolled onto the sonelokimab arm, 39% achieved a PPPASI score reduction of 75% or more.
In a 5 November statement, MoonLake noted that these data suggest that sonelokimab could “provide clinically meaningful improvements” in a disease where a therapy is yet to gain approval in the US and EU.
To test this theory, MoonLake will progress sonelokimab to Phase III in PPP, which the biotech expects to begin in Q3 2026.
According to GlobalData’s Intelligence Center, there are ten ongoing clinical trials in the PPP indication spanning Phases I to IV. Of these trials, key names include Johnson & Johnson’s blockbuster seller Tremfya (guselkumab) and AbbVie’s Rinvoq (upadacitinib).
Across all their approved indications, analysts at GlobalData forecast that Tremfya and Rinvoq will bring in $9.1bn and $15bn in 2031, respectively.
GlobalData is the parent company of Clinical Trials Arena.
