vTv Therapeutics Announces Cadisegliatin Program for Type 1 Diabetes Placed on Clinical Hold
vTv Therapeutics Inc. (Nasdaq: VTVT) announced that the FDA has placed a clinical hold on its cadisegliatin program for type 1 diabetes, including the ongoing CATT1 Phase 3 trial. The hold is due to an unresolved chromatographic signal discovered in a recent human ADME study. The FDA requires an in vitro study to characterize this signal before the program can resume.
Key points:
- No patients had been dosed in CATT1 at the time of the hold
- Past clinical studies showed no concerning safety issues
- Cadisegliatin has been well-tolerated in over 500 subjects for up to six months
- The company is working to resolve the hold and resume enrollment quickly
vTv Therapeutics Inc. (Nasdaq: VTVT) ha annunciato che la FDA ha imposto un fermo clinico sul suo programma di cadisegliatina per il diabete di tipo 1, compreso il trial in corso CATT1 di fase 3. Il fermo è dovuto a un segnale cromatografico irrisolto scoperto in un recente studio ADME umano. La FDA richiede uno studio in vitro per caratterizzare questo segnale prima che il programma possa riprendere.
Punti chiave:
- Nessun paziente era stato trattato nel CATT1 al momento del fermo
- Studi clinici precedenti non hanno mostrato preoccupanti problemi di sicurezza
- La cadisegliatina è stata ben tollerata in oltre 500 soggetti per un massimo di sei mesi
- La compagnia sta lavorando per risolvere il fermo e riprendere rapidamente l'arruolamento
vTv Therapeutics Inc. (Nasdaq: VTVT) anunció que la FDA ha impuesto un suspensión clínica a su programa de cadisegliatina para diabetes tipo 1, incluyendo el ensayo en curso CATT1 de fase 3. La suspensión se debe a una señal cromatográfica no resuelta descubierta en un reciente estudio ADME en humanos. La FDA requiere un estudio in vitro para caracterizar esta señal antes de que el programa pueda reanudarse.
Puntos clave:
- No se habían administrado dosis a pacientes en CATT1 en el momento de la suspensión
- Estudios clínicos anteriores no mostraron problemas de seguridad preocupantes
- La cadisegliatina ha sido bien tolerada en más de 500 sujetos durante hasta seis meses
- La compañía está trabajando para resolver la suspensión y reanudar rápidamente la inscripción
vTv Therapeutics Inc. (Nasdaq: VTVT)는 FDA가 제1형 당뇨병에 대한 cadisegliatin 프로그램에 임상 보류를 걸었다고 발표했습니다. 이 보류는 최근 인간 ADME 연구에서 발견된 해결되지 않은 크로마토그래피 신호 때문입니다. FDA는 프로그램이 재개되기 전에 이 신호를 특성화하기 위해 인 비트로 연구를 요구합니다.
주요 사항:
- 보류 당시 CATT1에서 환자가 투여되지 않았습니다
- 이전 임상 연구에서는 심각한 안전 문제를 보이지 않았습니다
- Cadisegliatin은 500명 이상의 피험자에게 최대 6개월 동안 잘 내약되었습니다
- 회사는 보류를 해결하고 빠르게 등록을 재개하기 위해 노력하고 있습니다
vTv Therapeutics Inc. (Nasdaq: VTVT) a annoncé que la FDA a imposé un arrêt clinique sur son programme de cadisegliatine pour le diabète de type 1, y compris l'essai CATT1 de phase 3 en cours. Cet arrêt est dû à un signal chromatographique non résolu découvert dans une récente étude ADME chez l'homme. La FDA exige une étude in vitro pour caractériser ce signal avant que le programme puisse reprendre.
Points clés :
- Aucun patient n'avait été traité dans le CATT1 au moment de l'arrêt
- Des études cliniques antérieures n'ont montré aucun problème de sécurité préoccupant
- La cadisegliatine a été bien tolérée chez plus de 500 sujets pendant jusqu'à six mois
- La société travaille à résoudre l'arrêt et à reprendre rapidement l'inscription
vTv Therapeutics Inc. (Nasdaq: VTVT) gab bekannt, dass die FDA ein klinisches Halt für ihr Cadisegliatin-Programm bei Typ-1-Diabetes verhängt hat, einschließlich der laufenden CATT1 Phase-3-Studie. Der Halt ist auf ein ungelöstes chromatografisches Signal zurückzuführen, das in einer kürzlich durchgeführten humanen ADME-Studie entdeckt wurde. Die FDA verlangt eine in vitro Studie, um dieses Signal zu charakterisieren, bevor das Programm wieder aufgenommen werden kann.
Wichtige Punkte:
- Zum Zeitpunkt des Halts wurden keine Patienten in CATT1 behandelt
- Frühere klinische Studien zeigten keine besorgniserregenden Sicherheitsprobleme
- Cadisegliatin wurde von über 500 Probanden bis zu sechs Monate lang gut vertragen
- Das Unternehmen arbeitet daran, den Halt zu lösen und die Rekrutierung schnell wieder aufzunehmen
- Cadisegliatin has shown compelling efficacy and favorable safety profile in over 500 subjects
- The company is actively working with the FDA to resolve the clinical hold
- No concerning safety issues were revealed in past clinical studies
- FDA placed a clinical hold on the cadisegliatin program, including the CATT1 Phase 3 trial
- The clinical hold delays the development and potential approval of cadisegliatin for type 1 diabetes
- An unresolved chromatographic signal was discovered in a recent human ADME study
Insights
The FDA's clinical hold on vTv Therapeutics' cadisegliatin program is a significant setback for the company's type 1 diabetes treatment pipeline. This development raises several important points:
- Regulatory Hurdle: The FDA's decision, based on an unresolved chromatographic signal in a recent ADME study, underscores the rigorous safety standards in drug development. This unexpected issue highlights the complexities and uncertainties inherent in the pharmaceutical approval process.
- Timeline Impact: While vTv Therapeutics is working to resolve the issue with a single in vitro study, the clinical hold will inevitably delay the CATT1 Phase 3 trial. This could potentially push back the timeline for cadisegliatin's market entry, affecting the company's competitive position in the diabetes treatment landscape.
- Financial Implications: For a late-stage biopharmaceutical company like vTv, delays in its lead program can have significant financial repercussions. Investors should closely monitor the company's cash burn rate and funding situation during this period of clinical hold.
- Market Opportunity: Despite this setback, the potential market for an oral therapy in type 1 diabetes remains substantial. If cadisegliatin can overcome this hurdle and demonstrate efficacy and safety in Phase 3 trials, it could still capture a significant share of this unmet medical need.
Investors should remain cautious but attentive to updates from vTv Therapeutics regarding the resolution of this clinical hold and the subsequent progress of the cadisegliatin program.
The clinical hold on vTv Therapeutics' cadisegliatin program reveals some intriguing aspects of the drug development process:
- ADME Study Significance: The discovery of an unresolved chromatographic signal in the ADME study is a important finding. ADME studies are essential for understanding how a drug behaves in the body and any anomalies can raise red flags about potential safety issues or unexpected metabolic pathways.
- Safety Profile: It's noteworthy that cadisegliatin has been well-tolerated in over 500 subjects for up to six months of treatment without clinically concerning safety issues. This extensive safety data provides some reassurance, but the FDA's caution is warranted given the uncharacterized signal.
- Regulatory Diligence: The FDA's decision to require further characterization of the signal through an in vitro study demonstrates the agency's commitment to thorough safety evaluation, even for promising therapies addressing significant unmet needs.
- Study Design: The fact that no patients had been dosed in the CATT1 Phase 3 trial at the time of the clinical hold is fortunate, as it minimizes potential risks to study participants and simplifies the process of addressing the FDA's concerns.
The resolution of this clinical hold will depend on vTv's ability to quickly and satisfactorily characterize the chromatographic signal. The outcome of the required in vitro study will be important in determining the future of the cadisegliatin program.
HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment.
The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. The Agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.
“Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator with first-in- class potential as an adjunct treatment for type 1 diabetes (T1D). Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.
About vTv Therapeutics
vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class adjunctive therapy to insulin for the treatment of type 1 diabetes.
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Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com
FAQ
What caused the FDA to place a clinical hold on vTv Therapeutics' cadisegliatin program?
How many subjects have been treated with cadisegliatin (VTVT) to date?
What is required for vTv Therapeutics (VTVT) to resume the cadisegliatin clinical program?
Were any patients dosed in the CATT1 Phase 3 trial before the clinical hold on VTVT's cadisegliatin?
