Ventyx Biosciences Announces Results from the Phase 2 Trial of VTX958 in Participants with Moderately to Severely Active Crohn’s Disease
Ventyx Biosciences (Nasdaq: VTYX) announced results from the Phase 2 trial of VTX958 in Crohn's disease. The trial did not meet its primary endpoint of change in mean CDAI score from baseline to Week 12 due to a higher than anticipated placebo response. However, both VTX958 dose groups (225 mg and 300 mg twice daily) achieved nominal statistical significance on the key secondary endpoint of endoscopic response as measured by SES-CD.
The trial enrolled 109 participants and showed a dose-dependent treatment effect on endoscopic response. VTX958 was well-tolerated, with a safety profile consistent with previous trials. Despite these mixed results, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources. The company held $279.7 million in cash and equivalents as of June 30, 2024, which is expected to fund operations into at least the second half of 2026.
Ventyx Biosciences (Nasdaq: VTYX) ha annunciato i risultati della fase 2 della sperimentazione di VTX958 nella malattia di Crohn. Lo studio non ha raggiunto il suo obiettivo principale, ovvero il cambiamento del punteggio medio di CDAI dal basale alla settimana 12, a causa di una risposta al placebo superiore a quella prevista. Tuttavia, entrambi i gruppi di dosaggio di VTX958 (225 mg e 300 mg due volte al giorno) hanno raggiunto una significatività statistica nominale per l'importante endpoint secondario della risposta endoscopica come misurato da SES-CD.
Lo studio ha incluso 109 partecipanti e ha mostrato un effetto terapeutico dose-dipendente sulla risposta endoscopica. VTX958 è stato ben tollerato, con un profilo di sicurezza coerente con trial precedenti. Nonostante questi risultati misti, Ventyx non prevede di condurre ulteriori studi clinici su VTX958 utilizzando risorse interne. L'azienda deteneva $279.7 milioni in contante e equivalenti al 30 giugno 2024, una somma che dovrebbe garantire le operazioni almeno fino alla seconda metà del 2026.
Ventyx Biosciences (Nasdaq: VTYX) anunció los resultados del ensayo de fase 2 de VTX958 en la enfermedad de Crohn. El ensayo no alcanzó su objetivo principal de cambio en la puntuación media de CDAI desde el inicio hasta la Semana 12 debido a una respuesta al placebo más alta de lo anticipado. Sin embargo, ambos grupos de dosis de VTX958 (225 mg y 300 mg dos veces al día) lograron una significancia estadística nominal en el importante endpoint secundario de respuesta endoscópica medida por SES-CD.
El ensayo inscribió a 109 participantes y mostró un efecto terapéutico dependiente de la dosis en la respuesta endoscópica. VTX958 fue bien tolerado, con un perfil de seguridad consistente con ensayos anteriores. A pesar de estos resultados mixtos, Ventyx no anticipa realizar ensayos clínicos adicionales de VTX958 con recursos internos. La compañía tenía $279.7 millones en efectivo y equivalentes al 30 de junio de 2024, lo que se espera que financie las operaciones al menos hasta la segunda mitad de 2026.
벤틱스 생명과학(Ventyx Biosciences, Nasdaq: VTYX)은 크론병에 대한 VTX958의 2상 시험 결과를 발표했습니다. 이 시험은 기준선에서 12주까지의 평균 CDAI 점수 변화라는 주요 목표를 달성하지 못했습니다. 이는 예상보다 높은 플라세보 반응으로 인한 결과입니다. 그럼에도 불구하고 VTX958의 두 가지 용량 그룹(225mg 및 300mg, 하루 두 번)은 SES-CD로 측정한 중요한 2차 endpoint인 내시경 반응에서 명목상 통계적 유의성을 달성했습니다.
이번 시험에는 109명의 참가자가 등록되었으며, 내시경 반응에 대한 용량 의존적인 치료 효과가 나타났습니다. VTX958는 이전 시험과 일치하는 안전성 프로필을 가지고 잘 견뎌졌습니다. 이러한 혼합된 결과에도 불구하고 Ventyx는 내부 자원으로 VTX958에 대한 추가 임상 시험을 진행할 계획이 없습니다. 회사는 2024년 6월 30일 기준으로 2억 7970만 달러의 현금 및 현금 등을 보유하고 있으며, 이는 적어도 2026년 하반기까지 운영을 지원할 것으로 예상됩니다.
Ventyx Biosciences (Nasdaq: VTYX) a annoncé les résultats de l'essai de phase 2 de VTX958 dans la maladie de Crohn. L'essai n'a pas atteint son objectif principal de changement de la moyenne du score CDAI par rapport à la ligne de base jusqu'à la semaine 12 en raison d'une réponse au placebo plus élevée que prévu. Cependant, les deux groupes de dosage de VTX958 (225 mg et 300 mg deux fois par jour) ont atteint une significativité statistique nominale sur le principal critère secondaire de réponse endoscopique mesurée par SES-CD.
L'essai a inclus 109 participants et a montré un effet thérapeutique dépendant de la dose sur la réponse endoscopique. VTX958 a été bien toléré, avec un profil de sécurité cohérent avec des essais précédents. Malgré ces résultats mitigés, Ventyx n'envisage pas de réaliser d'autres essais cliniques sur VTX958 avec des ressources internes. Au 30 juin 2024, l'entreprise avait 279,7 millions de dollars en espèces et équivalents, ce qui devrait financer ses opérations au moins jusqu'à la seconde moitié de 2026.
Ventyx Biosciences (Nasdaq: VTYX) hat die Ergebnisse der Phase 2-Studie von VTX958 bei Morbus Crohn bekannt gegeben. Die Studie erreichte nicht ihr primäres Ziel einer Veränderung des mittleren CDAI-Wertes vom Ausgangswert bis Woche 12 aufgrund einer höheren als erwarteten Placeboantwort. Dennoch erreichten beide VTX958-Dosierungsgruppen (225 mg und 300 mg zweimal täglich) eine nominale statistische Signifikanz beim wichtigen sekundären Endpunkt der endoskopischen Antwort, gemessen mit SES-CD.
In der Studie wurden 109 Teilnehmer eingeschlossen, und es zeigte sich ein dosisabhängiger Behandlungseffekt auf die endoskopische Antwort. VTX958 wurde gut vertragen und wies ein Sicherheitsprofil auf, das mit früheren Studien übereinstimmt. Trotz dieser gemischten Ergebnisse rechnet Ventyx nicht damit, weitere klinische Studien zu VTX958 mit internen Ressourcen durchzuführen. Das Unternehmen verfügte am 30. Juni 2024 über 279,7 Millionen US-Dollar in bar und Äquivalenten, was voraussichtlich die Betriebsabläufe bis mindestens zur zweiten Hälfte des Jahres 2026 sichern wird.
- Both VTX958 dose groups achieved nominal statistical significance on endoscopic response
- VTX958 showed a dose-dependent treatment effect on endoscopic response
- VTX958 was well-tolerated with a safety profile consistent with previous trials
- Company has $279.7 million in cash and equivalents, sufficient to fund operations into at least second half of 2026
- Phase 2 trial did not meet its primary endpoint of change in mean CDAI score
- Higher than anticipated placebo response affected primary endpoint results
- Company does not anticipate conducting additional clinical trials of VTX958 with internal resources
Insights
The Phase 2 trial results for VTX958 in Crohn's disease present a complex picture. While the primary endpoint of change in CDAI score was not met, likely due to a higher-than-expected placebo response, there are some encouraging secondary findings. The dose-dependent endoscopic response, achieving nominal statistical significance (p<0.05 for 225 mg and p<0.01 for 300 mg doses), is particularly noteworthy. Endoscopic response, measured by SES-CD, is considered a more objective measure of disease activity compared to the patient-reported CDAI.
The biomarker data, showing greater decreases in C-reactive protein and fecal calprotectin compared to placebo, further supports the potential anti-inflammatory effects of VTX958. These objective measures align with the endoscopic findings, suggesting that the drug may be having a biological effect despite the lack of significant improvement in patient-reported symptoms.
However, the discordance between symptomatic and endoscopic responses is concerning and warrants further investigation. This disconnect could be due to various factors, including the subjective nature of CDAI, potential placebo effects on symptoms, or a lag between mucosal healing and symptom improvement. The company's decision to halt further internal development of VTX958 for Crohn's disease suggests that they view these mixed results as insufficient to justify continued investment, despite some promising signals.
Ventyx Biosciences' announcement regarding VTX958's Phase 2 trial results in Crohn's disease has significant financial implications. The failure to meet the primary endpoint is likely to negatively impact investor confidence and the company's stock price in the short term. However, the situation is nuanced due to the positive secondary endpoint results.
The company's decision not to pursue further clinical trials of VTX958 with internal resources is a critical point. This suggests a strategic shift that could conserve cash but may limit future revenue potential from this asset. With
Investors should consider the following:
- The mixed results may impact Ventyx's ability to partner or out-license VTX958, potentially affecting future revenue streams.
- The company's other pipeline assets now become more critical for long-term value creation.
- The extended cash runway allows time for the company to advance other programs or potentially acquire new assets.
While the news is disappointing, Ventyx's strong cash position mitigates some of the near-term financial risks. However, the market will likely reassess the company's valuation based on the reduced potential of VTX958 and the strength of the remaining pipeline.
The Phase 2 trial of VTX958 in Crohn’s disease did not meet its primary endpoint of change from baseline in mean CDAI score in either VTX958 dose group
Both VTX958 dose groups achieved nominal statistical significance on the key secondary endpoint of endoscopic response as measured by SES-CD
At this time, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources
SAN DIEGO, July 29, 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 results from the Phase 2 trial of its allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn’s disease.
The Phase 2 trial enrolled 109 participants randomized to one of two VTX958 doses (225 mg and 300 mg twice daily) or placebo for a 12-week induction treatment period, followed by a long-term extension period. The primary endpoint was the change in the mean Crohn’s disease activity index (CDAI) score (a patient reported outcome) from baseline to Week 12. A key secondary endpoint in this trial was endoscopic response, defined as a
The trial did not meet its primary endpoint of change in mean CDAI score from baseline to Week 12 due to a higher than anticipated placebo response.
A dose-dependent treatment effect was observed on the key secondary endpoint of endoscopic response, at both the 225 mg and 300 mg doses (nominal p-value <0.05 and <0.01, respectively). Endoscopic response, evaluated by centrally read endoscopy, is considered an objective outcome and a high priority treatment goal. Both doses of VTX958 also showed a greater magnitude of decrease compared to placebo in two key biomarkers of inflammation, C-reactive protein and fecal calprotectin. VTX958 was well tolerated in the Phase 2 trial. The overall safety profile was consistent with previously conducted trials of VTX958.
Based on these results, the Company intends to conduct further analyses of the data to better understand the discordance between symptomatic and endoscopic response data. At this time, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources.
The Company held cash, cash equivalents and marketable securities of
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 need 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: Ventyx’s expectation that no further clinical trials of VTX958 will be conducted with internal resources; the continued analysis of the discordance between symptomatic and endoscopic response data, and any ability to draw conclusions therefrom; and the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities. 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: whether any insights can be derived from the analysis of the discordance between symptomatic and endoscopic response data in the Phase 2 trial; potential delays in the commencement, enrollment and completion of clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; 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-K for the quarter ended March 31, 2024, filed on May 9, 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
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