Why MoonLake Immunotherapeutics Stock Is Shooting Higher Today

MoonLake Immunotherapeutics MLTX released topline results from its Phase 2 MIRA trial evaluating the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS).

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring.

The MIRA trial is the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint, representing a milestone in HS clinical development.

Also Read: Cantor On MoonLake Immunotherapeutics - Initiates On Inexpensive Valuation, Strong Catalyst Path.

Both sonelokimab 120mg and 240mg doses achieved significantly higher HiSCR75 response rates than the placebo at week 12.

Both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg dose achieved a 29 ppt delta to placebo on HiSCR75 (p=0.0002) and a 38ppt delta to placebo on HiSCR50 (p<0.0001)

Other secondary endpoints, such as HiSCR90, improvements in International Hidradenitis Suppurativa Severity Score System (IHS) 4, abscess/nodule and draining tunnel counts, patient-reported pain, and quality of life outcomes, also reached statistical significance at week 12.

MoonLake's CEO expresses confidence in the positive trial outcome and the company's goal to become a leader in the inflammation and immunology space.

The MIRA trial will continue to week 24 with a 4-week safety follow-up to collect longer-term efficacy and safety data.

Sonelokimab has shown promise in Phase 2b trial for plaque-type psoriasis, and it is currently being evaluated in a Phase 2 trial for psoriatic arthritis.

Price Action: MLTX shares ae trading higher by 58.5% at $41 premarket on the last check Monday.