MoonLake Immunotherapeutics (NASDAQ:MLTX) stock is trading higher on Thursday with a session volume of 4.20 million compared to the average volume of 1.494 million, according to Benzinga Pro data.
Analyst Questions AbbVie Efficacy Against Existing Benchmarks
The jump comes in reaction to topline data from AbbVie Inc.’s (NYSE:ABBV) Phase 3 INTREPID study evaluating lutikizumab in adults and adolescents with moderate to severe hidradenitis suppurativa (HS).
In the INTREPID study, patients receiving lutikizumab achieved a 31.4% HiSCR75 response rate at Week 16, compared to 23.4% for placebo.
William Blair wrote, “The 8.0% treatment difference on HiSCR75 comes in below Phase III benchmarks in the HS space, which raises questions about the size of the market opportunity for lutikizumab.”
Analyst Matt Phipps highlighted that UCB SA’s (OTC:UCBJY) (OTC:UCBJF) Bimzelx (bimekizumab-bkzx), the approved best-in-class IL-17 targeting antibody in HS, led to a roughly 15% to 20% placebo-adjusted HiSCR75 response rate at week 16 in Phase 3 studies.
Sonelokimab Mechanism and Long-Term Phase Data
MoonLake Immunotherapeutics’ lead drug, sonelokimab, is a Nanobody for the treatment of inflammatory disease. It inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.
In June, MoonLake reported encouraging 52-week results from its Phase 3 VELA-1 and VELA-2 studies evaluating sonelokimab (SLK) for moderate-to-severe HS.
Pooled data from both Phase 3 studies showed that 67.2% of patients receiving SLK achieved HiSCR75 at Week 52, while 33.1% reached HiSCR100.
Additionally, 26% of treated patients achieved an IHS4-100 response, indicating complete resolution of inflammatory lesions, including abscesses, nodules, and draining tunnels.
In March, MoonLake announced that 62% of patients treated with sonelokimab achieved a HiSCR75 response by Week 40, setting a new standard for long-term lesion control in HS.
Anticipated 2027 Commercial Launch
MoonLake expects the FDA to determine whether to grant Priority Review when it accepts the BLA, with a potential commercial launch anticipated in the second half of 2027.
MLTX Stock Price Activity: MoonLake shares are trading higher by 18.59% at $12.63 at the time of publication on Thursday, according to Benzinga Pro data.
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