Brief: MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)

MoonLake Immunotherapeutics

26/02/2024 13:22

Feb 26 (Reuters) - MoonLake Immunotherapeutics  MLTX.O :
    * MOONLAKE IMMUNOTHERAPEUTICS ANNOUNCES POSITIVE FEEDBACK
FROM
BOTH FDA AND EMA ON REGULATORY PATH FOR THE PHASE 3 PROGRAM OF
THE NANOBODY® SONELOKIMAB (SLK) IN HIDRADENITIS SUPPURATIVA (HS)
    * MOONLAKE IMMUNOTHERAPEUTICS - CLARIFIED PATH FOR HS PHASE
3
PROGRAM WITH STUDY DESIGN, PATIENT POPULATION AND ENDPOINTS
AGREED
    * MOONLAKE IMMUNOTHERAPEUTICS - ONE DOSE OF SLK (120MG) TO
BE
TESTED WITH A SIMILAR PROTOCOL AS IN PHASE 2
    * MOONLAKE IMMUNOTHERAPEUTICS - TOTAL PHASE 3 POPULATION OF
800
PATIENTS TO BE COMPLEMENTED BY PHASE 2 POPULATION FOR
REGISTRATION
    * MOONLAKE IMMUNOTHERAPEUTICS - PHASE 3 TRIAL HAS SIMILAR
DESIGN
TO VALIDATED PHASE 2 TRIAL AND IN LINE WITH COMPANY'S
COMMUNICATIONS AND EXPECTATIONS
    * MOONLAKE IMMUNOTHERAPEUTICS - FIRST PATIENT EXPECTED TO BE
RANDOMIZED IN Q2 2024, PRIMARY ENDPOINT READOUT EXPECTED
MID-2025

Source text for Eikon:  ID:nGNX8jFrjP 
Further company coverage:  MLTX.O 

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