BioAge Labs Announces Discontinuation of STRIDES Phase 2 Clinical Trial Evaluating Azelaprag in Combination with Tirzepatide for the Treatment of Obesity
BioAge Labs (BIOA) has announced the discontinuation of its STRIDES Phase 2 clinical trial evaluating azelaprag in combination with tirzepatide for obesity treatment. The decision follows observations of liver transaminitis in some subjects receiving azelaprag, though without clinically significant symptoms. The study, which enrolled 204 subjects, was designed to evaluate two oral doses of azelaprag combined with tirzepatide in individuals aged 55 and older with obesity.
The company will analyze available data from enrolled subjects and plans to share updated plans for azelaprag in Q1 2025. In parallel, BioAge continues advancing its pipeline, including a brain-penetrant NLRP3 inhibitor program targeting neuroinflammation, with IND submission anticipated in second half of 2025.
BioAge Labs (BIOA) ha annunciato la cessazione del suo trial clinico di Fase 2, STRIDES, che valutava azelaprag in combinazione con tirzepatide per il trattamento dell'obesità. La decisione è stata presa a seguito di osservazioni di transaminite epatica in alcuni soggetti che ricevevano azelaprag, sebbene senza sintomi clinicamente significativi. Lo studio, che ha arruolato 204 soggetti, era progettato per valutare due dosi orali di azelaprag combinate con tirzepatide in individui di 55 anni e oltre con obesità.
La società analizzerà i dati disponibili dai soggetti arruolati e prevede di condividere piani aggiornati per azelaprag nel primo trimestre del 2025. Parallelamente, BioAge continua a far avanzare il suo pipeline, incluso un programma di inibitori NLRP3 penetranti nel cervello che mira alla neuroinfiammazione, con una presentazione IND prevista nella seconda metà del 2025.
BioAge Labs (BIOA) ha anunciado la interrupción de su ensayo clínico de Fase 2, STRIDES, que evaluaba azelaprag en combinación con tirzepatide para el tratamiento de la obesidad. La decisión siguió a observaciones de transaminitis hepática en algunos sujetos que recibieron azelaprag, aunque sin síntomas clínicamente significativos. El estudio, que inscribió a 204 sujetos, estaba diseñado para evaluar dos dosis orales de azelaprag combinadas con tirzepatide en individuos de 55 años o más con obesidad.
La empresa analizará los datos disponibles de los sujetos inscritos y planea compartir planes actualizados para azelaprag en el primer trimestre de 2025. Al mismo tiempo, BioAge sigue avanzando en su pipeline, incluido un programa de inhibidores de NLRP3 que penetran en el cerebro, enfocado en la neuroinflamación, con un envío de IND anticipado para la segunda mitad de 2025.
BioAge Labs (BIOA)는 비만 치료를 위한 tirzepatide와 함께 azelaprag를 평가하는 STRIDES Phase 2 임상 시험의 중단을 발표했습니다. 이 결정은 azelaprag를 투여받은 일부 피험자에서 임상적으로 중요한 증상 없이 간 트랜스아미나타이 전환이 관찰된 이후 내려졌습니다. 204명의 피험자를 모집한 이 연구는 55세 이상의 비만인에서 tirzepatide와 함께 azelaprag의 두 가지 경구 투여 용량을 평가하기 위해 설계되었습니다.
회사는 모집된 피험자로부터 이용 가능한 데이터를 분석하고, 2025년 1분기에 azelaprag에 대한 업데이트된 계획을 공유할 계획입니다. 동시에 BioAge는 신경 염증을 겨냥한 뇌 침투 NLRP3 억제제 프로그램을 포함하여 파이프라인을 지속적으로 발전시키고 있으며, 2025년 하반기에 IND 제출이 예상됩니다.
BioAge Labs (BIOA) a annoncé l'arrêt de son essai clinique de Phase 2, STRIDES, évaluant azelaprag en combinaison avec tirzepatide pour le traitement de l'obésité. Cette décision fait suite à des observations de transaminitis hépatique chez certains sujets recevant azelaprag, bien qu'aucun symptôme cliniquement significatif n'ait été observé. L'étude, qui a recruté 204 sujets, a été conçue pour évaluer deux doses orales d'azelaprag en association avec tirzepatide chez des personnes de 55 ans et plus souffrant d'obésité.
La société analysera les données disponibles des sujets recrutés et prévoit de partager des plans actualisés pour azelaprag au premier trimestre de 2025. Parallèlement, BioAge continue de faire avancer son pipeline, y compris un programme d'inhibiteurs NLRP3 pénétrants dans le cerveau ciblant la neuroinflammation, avec une soumission IND prévue pour la deuxième moitié de 2025.
BioAge Labs (BIOA) hat die Einstellung seiner klinischen Studie der Phase 2, STRIDES, angekündigt, die azelaprag in Kombination mit tirzepatide zur Behandlung von Adipositas bewertet. Die Entscheidung folgte auf Beobachtungen von Lebertransaminitis bei einigen Probanden, die azelaprag erhielten, jedoch ohne klinisch signifikante Symptome. Die Studie, die 204 Probanden einschloss, wurde konzipiert, um zwei orale Dosen von azelaprag in Kombination mit tirzepatide bei Personen ab 55 Jahren mit Adipositas zu bewerten.
Das Unternehmen wird verfügbare Daten der eingeschriebenen Probanden analysieren und plant, im ersten Quartal 2025 aktualisierte Pläne für azelaprag bekannt zu geben. Parallel dazu entwickelt BioAge weiterhin sein Portfolio, einschließlich eines Gehirn-penetranten NLRP3-Inhibitorprogramms, das auf Neuroinflammation abzielt, mit einer IND-Einreichung, die in der zweiten Hälfte des Jahres 2025 erwartet wird.
- Pipeline diversification with brain-penetrant NLRP3 inhibitor program progressing toward IND submission
- Early identification of safety concerns before larger-scale trials
- Discontinuation of STRIDES Phase 2 trial due to safety concerns
- Liver transaminitis observed in 11 subjects receiving azelaprag
- Significant setback in company's obesity treatment program
- Potential delay in drug development timeline
Insights
The discontinuation of BioAge's STRIDES Phase 2 trial represents a significant setback in the competitive obesity drug market. The observation of liver transaminitis in subjects receiving azelaprag raises serious safety concerns, particularly given the liver's important role in metabolism. While the absence of clinically significant symptoms is somewhat reassuring, elevated liver enzymes often indicate potential hepatotoxicity that could become problematic with prolonged use.
The trial's design, combining azelaprag with tirzepatide (Mounjaro/Zepbound), was strategically positioned to compete in the rapidly growing GLP-1 market. However, with 11 subjects out of 204 enrolled showing liver enzyme elevations, this represents a concerning safety signal that could significantly impact the drug's future development path. The company's pivot to their NLRP3 inhibitor program suggests a strategic realignment towards neuroinflammation and metabolic diseases through an alternative mechanism.
This development will likely have a substantial negative impact on BioAge's market position and valuation. The obesity treatment market, particularly GLP-1 combination therapies, represents a multi-billion dollar opportunity. The discontinuation of STRIDES removes BioAge from near-term competition in this lucrative space. While the company has other pipeline assets, including the NLRP3 inhibitor program, these are earlier stage with IND submission not expected until H2 2025.
The safety concerns with azelaprag could make future development challenging, potentially requiring significant resources for reformulation or dose modification. This setback may also impact investor confidence in BioAge's platform-based drug discovery approach. The company's ability to advance its remaining pipeline and maintain sufficient capital runway becomes increasingly critical.
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag
Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025
In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of 2025
RICHMOND, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- BioAge Labs (Nasdaq: BIOA) (“BioAge”, “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company has made the decision to discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag as monotherapy and in combination with tirzepatide after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag. No transaminase elevations were observed in the tirzepatide only treatment group.
“Patient safety is our top priority in the conduct of our clinical studies,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “We made the difficult decision to discontinue the STRIDES Phase 2 study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy. While this outcome is a significant disappointment, we remain encouraged by azelaprag’s promising preclinical and Ph1b efficacy profile. We remain committed to our focus on developing therapies for metabolic aging. In parallel to assessing the next steps for the azelaprag program, we will continue to advance our NLRP3 inhibitor program as well as additional research programs with novel mechanisms emerging from our platform.”
STRIDES is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enroll approximately 220 individuals with obesity aged 55 years and older (link). The trial was designed to evaluate the efficacy as measured by body weight reduction and other outcomes, safety, and tolerability of two oral doses of azelaprag (300 mg, once or twice daily) in combination with tirzepatide (5 mg subcutaneous injection once weekly). An azelaprag monotherapy arm was included to provide additional safety information.
Of 204 subjects enrolled in STRIDES as of today, 11 subjects in the azelaprag treatment groups were observed to have transaminase elevations with no clinically significant symptoms. Dosing of all subjects will be discontinued, and no additional subjects will be enrolled. Clinical follow-up of enrolled subjects will continue off drug. The Company intends to further analyze available STRIDES clinical data from all enrolled subjects. The Company has notified all study investigators and regulatory authorities including the U.S. Food and Drug Administration (FDA) of the Company’s decision to discontinue enrollment. The Company intends to share updated plans for azelaprag in Q1 2025.
BioAge continues to advance its pipeline of therapeutic candidates targeting the biology of aging to treat metabolic diseases. The Company's novel class of brain-penetrant NLRP3 inhibitors, which have demonstrated high potency and a novel binding site, are progressing toward IND submission, anticipated in the second half of 2025. The NLRP3 inhibitor program targets neuroinflammation, which is linked to both metabolic and neurodegenerative diseases. In addition, BioAge is advancing multiple targets derived from its proprietary discovery platform, which analyzes molecular data spanning over 50 years of human aging trajectories.
About BioAge Labs, Inc.
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that was observed to promote metabolism and prevent muscle atrophy on bed rest in a Phase 1b clinical trial. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, address key pathways in metabolic aging.
Forward-looking statements
This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, our business strategy, results of our ongoing or planned clinical trials, the timing of any future updates to our programs and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2024, and other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Elena Liapounova, ir@bioagelabs.com
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com
FAQ
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