LAD191 / Almirall - LARVOL DELTA

Safety, Pharmacokinetics, and Pharmacodynamics of LAD191, an IL-1RAP-Targeting Monoclonal Antibody, in Adults with Hidradenitis Suppurativa: Results from Part 3 of a Phase I Study (EADV 2025) - P1 | "Conclusion LAD191 was well tolerated and demonstrated a favorable safety and PK profile in patients with HS. Moreover, LAD191 has led to downstream cytokine reduction and early signs of clinical improvement in HS, supporting further clinical development."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Dermatology • Hidradenitis Suppurativa • Immunology • IL1RAP • IL6 • LCN2

Late-breaker: Phase I data on LAD191… (Almirall Press Release) - "...in patients affected by Hidradenitis Suppurativa suggest a favorable safety and tolerability profile, along with early signs of clinical improvement supporting the continued development of this asset."

Late-breaking abstract • P1 data • Hidradenitis Suppurativa

A Study of LAD191 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Almirall, S.A.

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

LAD191 data (Businesswire) - P1 | N=72 | NCT06488209 | Sponsor: Almirall, S.A. | "Almirall also presents progress on its early-stage pipeline showing data from the Phase I clinical study with LAD191, a high-affinity monoclonal antibody targeting interleukin-1 receptor accessory protein (IL-1RAP), which is in development for the treatment of immune-modulated skin diseases such as Hidradenitis suppurutiva. The results in healthy volunteers support the safety and tolerability and add to previous pre-clinical studies that have demonstrated LAD191’s ability to inhibit pro-inflammatory cytokines. Blocking multiple pathways through IL-1RaP inhibition is anticipated to provide greater clinical benefit in attenuating proinflammatory responses compared to single cytokine inhibition."

P1 data • Hidradenitis Suppurativa • Immunology

Phase I single and multiple ascending-dose study to assess the safety, tolerability and pharmacokinetics of LAD191, a monoclonal antibody against the interleukin-1 receptor accessory protein (IL-1RAP), in healthy volunteers (AAD 2025) - P1 | "LAD191 demonstrated a favorable safety and tolerability profile in healthy volunteers, supporting its further development for the treatment of autoimmune dermatological diseases."

Clinical • P1 data • PK/PD data • Dermatology • Immunology • IL1RAP

Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Almirall, S.A. | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Immunology

Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Almirall, S.A.

New P1 trial • Immunology