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
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.
ACELYRIN, INC. (Nasdaq: SLRN) ha annunciato risultati positivi dal suo studio clinico di Fase 3 globale su izokibep in pazienti con hidradenite suppurativa (HS) da moderata a grave. I risultati saranno presentati al 2024 European Academy of Dermatology and Venereology ad Amsterdam. Lo studio ha mostrato risposte statisticamente significative e clinicamente rilevanti su molteplici endpoint di efficacia, in particolare in risposte di ordine superiore come HiSCR90 e HiSCR100, dopo 12 settimane. Il Dr. Shephard Mpofu, Direttore Medico di ACELYRIN, ritiene che questi dati possano sostenere un percorso verso l'approvazione normativa per izokibep come trattamento per l'HS.
ACELYRIN, INC. (Nasdaq: SLRN) anunció resultados positivos de su ensayo clínico de Fase 3 global de izokibep en pacientes con hidradenitis supurativa (HS) de moderada a severa. Los resultados se presentarán en la 2024 European Academy of Dermatology and Venereology en Ámsterdam. El ensayo demostró respuestas estadísticamente significativas y clínicamente relevantes en múltiples puntos de eficacia, particularmente en respuestas de orden superior como HiSCR90 y HiSCR100, a las 12 semanas. El Dr. Shephard Mpofu, Director Médico de ACELYRIN, cree que estos datos podrían respaldar un camino hacia la aprobación regulatoria de izokibep como tratamiento para la HS.
ACELYRIN, INC. (Nasdaq: SLRN)는 중등도에서 중증 농피증 (HS) 환자를 대상으로 한 글로벌 3상 임상 시험의 긍정적인 결과를 발표했습니다. 이 결과는 암스테르담에서 열리는 2024 유럽 피부과 및 성병학 학회에서 발표될 예정입니다. 이 시험은 12주 후 통계적으로 유의미하고 임상적으로 의미 있는 반응을 여러 효능 기준에서 보여주었으며, 특히 HiSCR90 및 HiSCR100과 같은 고차 반응에서 두드러졌습니다. ACELYRIN의 최고 의학 책임자인 Dr. Shephard Mpofu는 이러한 데이터가 izokibep의 HS 치료를 위한 규제 승인으로 가는 길을 지원할 수 있다고 믿고 있습니다.
ACELYRIN, INC. (Nasdaq: SLRN) a annoncé des résultats positifs de son essai clinique de Phase 3 mondial sur izokibep chez des patients atteints d'hidradenite suppurative (HS) modérée à sévère. Les résultats seront présentés à la 2024 European Academy of Dermatology and Venereology à Amsterdam. L'essai a démontré des réponses statistiquement significatives et cliniquement pertinentes sur plusieurs critères d'efficacité, notamment dans des réponses de plus haut niveau telles que HiSCR90 et HiSCR100, après 12 semaines. Le Dr Shephard Mpofu, directeur médical d'ACELYRIN, pense que ces données pourraient soutenir un chemin vers l'approbation réglementaire d'izokibep comme traitement de la HS.
ACELYRIN, INC. (Nasdaq: SLRN) hat positive Ergebnisse aus seiner globalen Phase-3-Studie zu izokibep bei Patienten mit hidradenitis supurativa (HS) mittlerer bis schwerer Schwere bekannt gegeben. Die Ergebnisse werden auf der 2024 European Academy of Dermatology and Venereology in Amsterdam präsentiert. Die Studie zeigte statistisch signifikante und klinisch relevante Antworten über mehrere Wirksamkeitsendpunkte, insbesondere bei höheren Reaktionen wie HiSCR90 und HiSCR100, nach 12 Wochen. Dr. Shephard Mpofu, Chief Medical Officer von ACELYRIN, ist der Ansicht, dass diese Daten einen Weg zur regulatorischen Genehmigung für izokibep als Behandlung für HS unterstützen könnten.
- 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
- 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)?
