MoonLake Immunotherapeutics' Lead Skin Disorder Candidate Continues to Deliver on Best-Efficacy Profile: Analyst

MoonLake Immunotherapeutics MLTX announced 24-week topline results from its Phase 2 MIRA trial of sonelokimab for moderate-to-severe hidradenitis suppurativa (HS), following the 12-week results, in which the primary endpoint was met with 29 percentage points delta versus placebo at week 12. 

The data showed that the maintenance treatment with its Nanobody sonelokimab led to further improvements in HiSCR75 response rates and other clinically relevant outcomes.

The 24-week results show that ongoing treatment with sonelokimab 120mg and 240mg dosed Q4W further increased HiSCR75 response rates compared to week 12. 

57% of patients continuously treated with 120mg achieved a HiSCR75 response (more than 10 ppt improvement from Week 12), and 38% achieved HiSCR90 (more than 14ppt improvement versus week 12). 

The IHS4 score, which encompasses changes in all active HS lesions (nodules, abscesses, draining tunnels), decreased by 65% in patients treated with the 120mg maintenance dose.

Rates of complete resolution of inflammatory nodules and abscesses (AN 100) and draining tunnels (DT 100) increased between week 12 and 24.

Maintenance dosing, placebo cross-overs to sonelokimab 120mg or 240mg, and pharmacokinetic data confirm 120mg as the dose with optimal benefit-risk profile.

Needham writes that these 24-week MIRA trial results meet expectations of continued efficacy improvements from wk-12 to wk-24, leading to greater response depth and disease control. 

These data are another important derisking event for sonelokimab and the HS program. The focus now shifts to the readout of the phase 2 ARGO trial in psoriatic arthritis (PsA), expected in early November. The analyst maintains the Buy rating, with a price target of $76.

Price Action: MLTX shares are up 10.20% at $60.24 on the last check Monday.