ACELYRIN, INC. Announces Positive Results from Global Phase 3 Clinical Trial of Izokibep in Hidradenitis Suppurativa to be Highlighted in Late-Breaking Oral Presentation at EADV 2024

Rhea-AI Summary

ACELYRIN, INC. (Nasdaq: SLRN) announced positive results from its global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients. The results will be presented at the 2024 European Academy of Dermatology and Venereology in Amsterdam. The trial demonstrated statistically significant and clinically meaningful responses across multiple efficacy endpoints, particularly in higher order responses like HiSCR90 and HiSCR100, by 12 weeks. Dr. Shephard Mpofu, Chief Medical Officer of ACELYRIN, believes these data could support a path to regulatory approval for izokibep as a treatment for HS.

Positive

• Positive results from global Phase 3 clinical trial of izokibep in hidradenitis suppurativa
• Statistically significant and clinically meaningful responses across multiple efficacy endpoints
• Notable higher order responses in HiSCR90 and HiSCR100 by 12 weeks
• Data could potentially support regulatory approval for izokibep in HS treatment

Negative

• None.

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LOS ANGELES, Sept. 19, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients will be shared as a late-breaking oral presentation at the 2024 European Academy of Dermatology and Venereology taking place September 25-28, 2024 in Amsterdam, Netherlands. Presentation details are as follows:

Title:	Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Moderate-to-Severe Hidradenitis Suppurativa: Week 12 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study
Session Type:	Late-breaking Oral Presentation
Abstract ID:	7995
Date/Time:	Wednesday, September 25, 2024; 4:00 – 4:15PM CEST
Presenter:	Kim Papp, M.D., Ph.D., President and Director of Research, Probity Medical Research, Inc.

“The global Phase 3 clinical trial of izokibep as a treatment for HS demonstrated statistically significant and clinically meaningful responses across multiple efficacy endpoints – particularly in higher order responses such as HiSCR90 and HiSCR100 – by 12 weeks,” said Shephard (Shep) Mpofu, M.D., Chief Medical Officer of ACELYRIN. “We believe these data could support a path to regulatory approval in this indication and look forward to having the data presented in this important dermatology forum.”

About Izokibep
Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency through tight binding affinity, the potential for robust tissue penetration due to its small molecular size – about one-tenth the size of a monoclonal antibody – and an albumin binding domain that extends half-life. It is currently being evaluated in multiple late-stage trials in moderate-to-severe Hidradenitis Suppurativa (HS), moderate-to-severe psoriatic arthritis (PsA), and noninfectious uveitis. Phase 3 HS and PsA data presented to date have demonstrated levels of clinical response comparable with next generation approaches to IL-17 inhibition. ACELYRIN previously announced that it would discontinue internal development of izokibep in HS and PsA.

About ACELYRIN, INC.
ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease.

For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.

Forward Looking Statements
Some statements in this press release are, or may be considered, forward-looking statements, including statements regarding ACELYRIN’s progress, business plans and clinical trials, as well as the potential future benefits of our product candidates. While ACELYRIN, INC. considers any projections to be based on reasonable assumptions, these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated in such forward-looking statements.

ACELYRIN Contacts:
Tyler Marciniak
Vice President of Investor Relations and Corporate Affairs
investors@acelyrin.com
media@acelyrin.com

FAQ

What were the results of ACELYRIN's (SLRN) Phase 3 trial for izokibep in hidradenitis suppurativa?

ACELYRIN's Phase 3 trial for izokibep in hidradenitis suppurativa showed statistically significant and clinically meaningful responses across multiple efficacy endpoints, particularly in higher order responses such as HiSCR90 and HiSCR100, by 12 weeks.

When and where will ACELYRIN (SLRN) present the Phase 3 trial results for izokibep?

ACELYRIN will present the Phase 3 trial results for izokibep at the 2024 European Academy of Dermatology and Venereology in Amsterdam, Netherlands, on September 25, 2024.

What is the potential impact of the Phase 3 trial results for ACELYRIN's (SLRN) izokibep?

The positive Phase 3 trial results could potentially support a path to regulatory approval for izokibep as a treatment for hidradenitis suppurativa, according to ACELYRIN's Chief Medical Officer.

What is izokibep, the drug being tested by ACELYRIN (SLRN)?

Izokibep is a novel IL-17A inhibitor being developed by ACELYRIN for the treatment of moderate-to-severe hidradenitis suppurativa.