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.
Insights
The announcement of positive Phase 3 clinical trial results for izokibep in hidradenitis suppurativa (HS) is a significant development for ACELYRIN. The data showing statistically significant and clinically meaningful responses across multiple efficacy endpoints, especially in higher order responses like HiSCR90 and HiSCR100, is particularly noteworthy. This suggests izokibep could potentially offer superior efficacy compared to existing treatments.
The fact that these results were achieved by week 12 is impressive, indicating a relatively rapid onset of action. This could be a key differentiator in the HS treatment landscape. The mention of a potential path to regulatory approval based on these data is a important point for investors, as it suggests ACELYRIN may be moving closer to bringing a new product to market.
However, it's important to note that full details of the trial, including safety data and specific efficacy numbers, are not provided in this announcement. Investors should look forward to the full presentation at EADV for a more comprehensive understanding of izokibep's potential in HS treatment.
This announcement could have significant positive implications for ACELYRIN's financial outlook. Successful Phase 3 results in a condition like hidradenitis suppurativa (HS) could potentially lead to a lucrative new market opportunity. HS is a chronic, inflammatory skin condition with treatment options, representing an unmet medical need.
If izokibep gains regulatory approval for HS, it could become a major revenue driver for ACELYRIN. The global HS treatment market is projected to grow substantially in the coming years and a novel, efficacious treatment could capture a significant market share. Additionally, positive results in HS could increase confidence in izokibep's potential in other indications, potentially expanding its market opportunity further.
However, investors should be cautious as the path to commercialization still involves regulatory hurdles and potential competition. The company's ability to successfully navigate the approval process and effectively market the drug will be important factors to monitor.
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?
When and where will ACELYRIN (SLRN) present the Phase 3 trial results for izokibep?
What is the potential impact of the Phase 3 trial results for ACELYRIN's (SLRN) izokibep?
What is izokibep, the drug being tested by ACELYRIN (SLRN)?
