Ventyx Biosciences Presents New 52-Week Results from the Phase 2 Trial of VTX002 (Tamuzimod) in Ulcerative Colitis at UEG Week 2024
Ventyx Biosciences (Nasdaq: VTYX) presented new 52-week results from the Phase 2 trial of VTX002 (tamuzimod) in ulcerative colitis at UEG Week 2024. The late-breaking abstract highlighted high rates of clinical and endoscopic remission among long-term extension (LTE) completers at Week 52. CEO Raju Mohan emphasized the data's reinforcement of tamuzimod's potential best-in-class profile as an S1P1R modulator in ulcerative colitis, with a possibly best-in-disease safety profile among oral UC therapies. The company believes these results position tamuzimod as the backbone of future combination therapies for UC. The presentation, delivered by Dr. Silvio Danese, focused on the efficacy and safety of tamuzimod through 52 weeks in moderately to severely active ulcerative colitis.
Ventyx Biosciences (Nasdaq: VTYX) ha presentato nuovi risultati a 52 settimane dal trial di Fase 2 di VTX002 (tamuzimod) nella colite ulcerosa durante la UEG Week 2024. L'abstract in ritardo ha evidenziato elevate percentuali di remissione clinica ed endoscopica tra i partecipanti alla fase di estensione a lungo termine (LTE) al Week 52. Il CEO Raju Mohan ha sottolineato come i dati rafforzino il potenziale best-in-class profile di tamuzimod come modulatore S1P1R nella colite ulcerosa, con un possibile migliore profilo di sicurezza nella sua categoria tra le terapie orali per la UC. L'azienda crede che questi risultati pongano tamuzimod come fondamento delle future terapie combinate per la UC. La presentazione, effettuata dal Dr. Silvio Danese, si è concentrata sull'efficacia e la sicurezza di tamuzimod per 52 settimane in pazienti con colite ulcerosa moderatamente a severamente attiva.
Ventyx Biosciences (Nasdaq: VTYX) presentó nuevos resultados a 52 semanas del ensayo de Fase 2 de VTX002 (tamuzimod) en colitis ulcerosa en la UEG Week 2024. El resumen de última hora destacó altas tasas de remisión clínica y endoscópica entre los participantes que completaron la extensión a largo plazo (LTE) a la Semana 52. El CEO Raju Mohan enfatizó que los datos refuerzan el potencial mejor en su clase de tamuzimod como modulador S1P1R en colitis ulcerosa, con un posible mejor perfil de seguridad en la enfermedad entre las terapias orales para la UC. La compañía cree que estos resultados posicionan a tamuzimod como la base de futuras terapias combinadas para la UC. La presentación, realizada por el Dr. Silvio Danese, se centró en la eficacia y seguridad de tamuzimod durante 52 semanas en colitis ulcerosa de moderada a severamente activa.
Ventyx Biosciences (Nasdaq: VTYX)는 UEG Week 2024에서 VTX002 (타무지모드)에 대한 2상 시험의 52주 새로운 결과를 발표했습니다. 후속 발표에서 임상 및 내시경 관해의 높은 비율이 52주차의 장기 확장(LTE) 완료자들 사이에서 강조되었습니다. CEO Raju Mohan은 데이터가 타무지모드의 최고의 클래스 프로파일로서의 잠재력을 강화한다고 강조했습니다. 이는 UC에 대한 경구 치료제 중에서 질병 내 최고의 안전성 프로파일을 가질 가능성이 있습니다. 회사는 이 결과가 타무지모드를 UC를 위한 미래 복합 요법의 중추로 자리매김할 것이라고 믿고 있습니다. Silvio Danese 박사가 발표한 내용은 중등도에서 중증의 활동성 대장염에서 52주 동안 타무지모드의 효능 및 안전성에 초점을 맞췄습니다.
Ventyx Biosciences (Nasdaq: VTYX) a présenté de nouveaux résultats à 52 semaines de l'essai de Phase 2 de VTX002 (tamuzimod) dans le cadre de la colite ulcéreuse lors de la UEG Week 2024. Le résumé à la dernière minute a mis en avant des taux élevés de rémission clinique et endoscopique parmi les participants à l'extension à long terme (LTE) à la Semaine 52. Le PDG Raju Mohan a souligné que les données renforcent le potentiel de tamuzimod en tant que meilleur de sa catégorie en tant que modulateur S1P1R dans la colite ulcéreuse, avec peut-être un meilleur profil de sécurité dans la maladie parmi les thérapies orales pour la UC. L'entreprise estime que ces résultats positionnent tamuzimod comme le pilier des futures thérapies combinées pour la UC. La présentation, donnée par Dr. Silvio Danese, s'est concentrée sur l'efficacité et la sécurité de tamuzimod pendant 52 semaines dans le cadre d'une colite ulcéreuse modérément à sévèrement active.
Ventyx Biosciences (Nasdaq: VTYX) hat auf der UEG Week 2024 neue Ergebnisse zu 52 Wochen aus der Phase-2-Studie zu VTX002 (Tamuzimod) bei kolitis ulcerosa vorgestellt. Das kurzfristig eingereichte Abstract hob die hohen Raten von klinischer und endoskopischer Remission unter den Teilnehmern der Langzeitverlängerung (LTE) in Woche 52 hervor. CEO Raju Mohan betonte, dass die Daten das Potenzial von Tamuzimod als Best-in-Class-Profil als S1P1R-Modulator bei kolitis ulcerosa untermauern, mit möglicherweise bestem Sicherheitsprofil in der Erkrankung unter den oralen UC-Therapien. Das Unternehmen glaubt, dass diese Ergebnisse Tamuzimod als Fundament zukünftiger Kombinationstherapien für UC positionieren. Die Präsentation von Dr. Silvio Danese konzentrierte sich auf die Wirksamkeit und Sicherheit von Tamuzimod über 52 Wochen bei moderat bis stark aktiver kolitis ulcerosa.
- High rates of clinical and endoscopic remission at Week 52
- Potential best-in-class profile as S1P1R modulator in ulcerative colitis
- Possible best-in-disease safety profile among oral UC therapies
- Positioning as backbone for future combination therapies in UC
- None.
Insights
The presentation of 52-week data from the Phase 2 trial of tamuzimod (VTX002) in ulcerative colitis (UC) at UEG Week 2024 is a significant milestone for Ventyx Biosciences. The long-term extension results highlight high rates of clinical and endoscopic remission among study completers, which is important for chronic conditions like UC.
Key points to consider:
- Tamuzimod, an S1P1R modulator, shows potential as a best-in-class therapy for UC
- The drug demonstrates a promising safety profile compared to other oral UC treatments
- High remission rates suggest tamuzimod could become a foundational treatment in combination therapies
While these results are encouraging, investors should note that this is still Phase 2 data. The company will need to confirm these findings in larger Phase 3 trials before seeking regulatory approval. The potential market for UC treatments is substantial, but competition is fierce. Tamuzimod's safety profile could be a key differentiator if maintained in later-stage trials.
From a financial perspective, the positive long-term data for tamuzimod is encouraging for Ventyx Biosciences (NASDAQ: VTYX). The ulcerative colitis market is projected to reach
Key financial considerations:
- Ventyx's market cap of
$167.5 million suggests potential upside if tamuzimod continues to show promise - Positive Phase 2 data may attract partnership opportunities or increase the company's appeal as an acquisition target
- Successful development could lead to expanded indications, further increasing market potential
However, investors should be cautious. Clinical-stage biotech companies carry high risk and Ventyx will likely need additional funding to complete Phase 3 trials. The company's cash runway and ability to finance future development will be critical factors to monitor. While the news is positive, it's important to consider the long road ahead in drug development and the competitive landscape in the UC market.
Late-breaking abstract highlights high rates of clinical and endoscopic remission among LTE completers at Week 52
SAN DIEGO, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that a late-breaking abstract including new long-term extension (LTE) data from the Phase 2 trial of tamuzimod in ulcerative colitis was presented on October 15, 2024 during the United European Gastroenterology (UEG) Week meeting in Vienna, Austria.
“We are excited to present the new long-term extension data from the tamuzimod Phase 2 trial in patients with ulcerative colitis at UEG Week,” said Raju Mohan, PhD, Chief Executive Officer. “These 52-week data continue to reinforce the potential best-in-class profile of our S1P1R modulator tamuzimod in ulcerative colitis, with a potential best-in-disease safety profile amongst all the oral options for UC therapy. We believe the high rates of clinical remission and endoscopic remission position tamuzimod as the backbone of future combination therapies for UC.”
Oral Presentation Details:
Presenter: Silvio Danese, MD, PhD; Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy
Session: From IBS and IBD: Late-breaking abstracts
Session Date/Time: Tuesday, October 15, 2024, 08:30 - 09:30 (CEST)
More information can be found in the conference program on the UEG website. Slides from the presentation will be available in the Investors section of the company’s website at www.ventyxbio.com.
About Ventyx Biosciences
Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com.
Forward-Looking Statements
Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates and the anticipated continued progression of the development pipeline for such product candidates; the therapeutic and commercial potential of VTX002 in ulcerative colitis, including its efficacy profile, potential as a best-in-disease oral agent and its potential best-in-class safety profile; and the use of tamuzimod in combination with other therapies for ulcerative colitis. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: the scientific or commercial utility achievable by combing tamuzimod with other therapies; potential delays in the enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed on August 8, 2024, and Ventyx’s subsequent filings with the SEC.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact
Patti Bank
Managing Director
ICR Westwicke
(415) 513-1284
IR@ventyxbio.com
FAQ
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