BioAge Labs Announces Company Updates on APJ, NLRP3, and Platform Programs
BioAge Labs announced significant updates to its clinical programs and platform development. The company has discontinued azelaprag development due to liver transaminitis observations in the STRIDES Phase 2 obesity trial, but is advancing next-generation APJ agonists with a development candidate expected by end of 2025.
The company nominated BGE-102, a brain-penetrant NLRP3 inhibitor, as a development candidate for neuroinflammation conditions, with Phase 1 SAD data expected by end of 2025. BioAge also expanded its discovery efforts through collaborations with Novartis (worth up to $550 million) and Lilly ExploR&D for antibody therapeutics development.
Financially, BioAge reported $334.5 million in cash and equivalents as of September 30, 2024, plus $27.6 million from IPO greenshoe exercise, extending runway beyond 2029.
BioAge Labs ha annunciato aggiornamenti significativi ai suoi programmi clinici e allo sviluppo della piattaforma. L'azienda ha interrotto lo sviluppo dell'azelaprag a causa di osservazioni di transaminite epatica nel trial di obesità STRIDES di Fase 2, ma sta avanzando con gli agonisti APJ di nuova generazione, con un candidato allo sviluppo previsto entro la fine del 2025.
L'azienda ha nominato BGE-102, un inibitore NLRP3 penetrante nel cervello, come candidato allo sviluppo per condizioni di neuroinfiammazione, con dati sulla Fase 1 SAD attesi entro la fine del 2025. BioAge ha anche ampliato i suoi sforzi di scoperta attraverso collaborazioni con Novartis (del valore fino a 550 milioni di dollari) e Lilly ExploR&D per lo sviluppo di terapie anticorpali.
Dal punto di vista finanziario, BioAge ha riportato 334,5 milioni di dollari in contante e equivalenti al 30 settembre 2024, più 27,6 milioni di dollari dall'esercizio del greenshoe dell'IPO, estendendo il percorso oltre il 2029.
BioAge Labs anunció actualizaciones significativas en sus programas clínicos y el desarrollo de su plataforma. La compañía ha interrumpido el desarrollo de azelaprag debido a observaciones de transaminitis hepática en el ensayo de obesidad STRIDES de Fase 2, pero está avanzando con los agonistas APJ de nueva generación, con un candidato de desarrollo esperado para finales de 2025.
La compañía ha nominado BGE-102, un inhibidor NLRP3 que penetra en el cerebro, como candidato de desarrollo para condiciones de neuroinflamación, con datos de Fase 1 SAD esperados para finales de 2025. BioAge también ha ampliado sus esfuerzos de descubrimiento a través de colaboraciones con Novartis (valoradas en hasta 550 millones de dólares) y Lilly ExploR&D para el desarrollo de terapias con anticuerpos.
Desde el punto de vista financiero, BioAge reportó 334.5 millones de dólares en efectivo y equivalentes al 30 de septiembre de 2024, además de 27.6 millones de dólares por el ejercicio del greenshoe de la OPI, extendiendo su camino más allá de 2029.
BioAge Labs는 임상 프로그램 및 플랫폼 개발에 대한 중요한 업데이트를 발표했습니다. 이 회사는 STRIDES 2상 비만 임상 시험에서 간 효소 상승 관찰로 인해 아젤라프라그 개발을 중단하였으나, 2025년 말까지 예상되는 개발 후보로 차세대 APJ 작용제를 진행하고 있습니다.
회사는 신경 염증 상태에 대한 개발 후보로 뇌 침투가 가능한 NLRP3 억제제 BGE-102를 지명했으며, 2025년 말까지 1상 SAD 데이터가 예상됩니다. BioAge는 또한 Novartis와 (최대 5억 5천만 달러의 가치) 및 Lilly ExploR&D와 협력하여 항체 치료제 개발을 위한 발견 노력을 확장했습니다.
재정적으로 BioAge는 2024년 9월 30일 기준으로 현금 및 현금성 자산 3억 3천 4백 50만 달러를 보고했으며, IPO greenshoe 행사로 2천 7백 60만 달러를 추가로 확보하여 2029년 이후까지 지속 가능한 경로를 이어갔습니다.
BioAge Labs a annoncé des mises à jour importantes concernant ses programmes cliniques et le développement de sa plateforme. La société a interrompu le développement de l'azelaprag en raison d'observations de transaminite hépatique dans l'essai clinique de phase 2 sur l'obésité STRIDES, mais avance avec des agonistes APJ de nouvelle génération, avec un candidat au développement prévu d'ici fin 2025.
La société a nommé BGE-102, un inhibiteur NLRP3 pénétrant dans le cerveau, comme candidat au développement pour des conditions de neuroinflammation, avec des données en phase 1 SAD attendues d'ici fin 2025. BioAge a également élargi ses efforts de découverte grâce à des collaborations avec Novartis (d'une valeur allant jusqu'à 550 millions de dollars) et Lilly ExploR&D pour le développement de thérapeutiques par anticorps.
Sur le plan financier, BioAge a déclaré 334,5 millions de dollars en liquidités et équivalents au 30 septembre 2024, ainsi que 27,6 millions de dollars provenant de l'exercice du greenshoe lors de l'introduction en bourse, prolongeant ainsi la marge de manœuvre au-delà de 2029.
BioAge Labs hat bedeutende Updates zu seinen klinischen Programmen und der Plattformentwicklung angekündigt. Das Unternehmen hat die Entwicklung von Azelaprag aufgrund von Beobachtungen zu Lebertransaminasen im STRIDES Phase-2-Adipositas-Test eingestellt, plant jedoch die Weiterentwicklung von APJ-Agonisten der nächsten Generation, mit einem erwarteten Entwicklungskandidaten bis Ende 2025.
Das Unternehmen hat BGE-102, einen das Gehirn durchdringenden NLRP3-Inhibitor, als Entwicklungskandidaten für neuroinflammatorische Erkrankungen nominiert, wobei die Phase-1-SAD-Daten bis Ende 2025 erwartet werden. BioAge hat auch seine Entdeckungsbemühungen durch Kooperationen mit Novartis (im Wert von bis zu 550 Millionen Dollar) und Lilly ExploR&D zur Entwicklung von Antikörpertherapeutika erweitert.
Finanziell berichtete BioAge zum 30. September 2024 über 334,5 Millionen Dollar in Bar und Bargeldäquivalenten sowie über 27,6 Millionen Dollar aus der Ausübung des Greenshoe der IPO, wodurch der finanzielle Spielraum über 2029 hinaus verlängert wurde.
- Strong cash position of $362.1M (including greenshoe proceeds) extending runway beyond 2029
- Secured Novartis collaboration worth up to $550M in payments and milestones
- Nominated BGE-102 as development candidate with potential best-in-class features
- New strategic collaboration with Lilly ExploR&D for antibody therapeutics
- Discontinuation of azelaprag due to liver safety concerns in Phase 2 trial
- Delay in APJ program with new candidate nomination pushed to end of 2025
Insights
The latest updates from BioAge Labs present a mixed but strategically sound picture for investors. The termination of azelaprag, while a setback, demonstrates prudent risk management in halting development upon safety concerns. This decision, though potentially disappointing for near-term catalysts, preserves capital for more promising programs.
The financial position is notably robust with
The Novartis collaboration, potentially worth up to
The nomination of BGE-102 as a development candidate, with anticipated Phase 1 data by year-end, provides a near-term catalyst. The NLRP3 inhibitor space is highly competitive, but BGE-102's brain penetration capability could differentiate it in the market, particularly for neuroinflammation indications.
This strategic repositioning suggests a thoughtful pipeline prioritization, balancing risk mitigation with maintaining multiple shots on goal. The strong cash position enables pursuit of these opportunities without near-term financing pressure, a significant advantage in the current market environment.
The pipeline updates reveal important strategic developments in BioAge's therapeutic approach. The termination of azelaprag due to liver transaminitis, while concerning, highlights the company's commitment to patient safety. The observation of liver enzyme elevations without clear dose dependence suggests a potential idiosyncratic reaction rather than a direct drug-related toxicity, which could be important for the development of next-generation APJ agonists.
The nomination of BGE-102 as a development candidate is particularly noteworthy. NLRP3 inhibition represents a highly pursued therapeutic strategy, but achieving effective brain penetration has been a significant challenge in the field. BGE-102's reported high brain penetration could provide a competitive advantage, especially for neuroinflammation-related conditions.
The company's platform expansion through collaborations with Novartis and Lilly demonstrates the versatility of their aging biology approach. The Novartis collaboration, focusing on the intersection of aging and exercise biology, represents a novel approach to target identification. The Lilly antibody development partnership suggests confidence in BioAge's target identification capabilities in the metabolic aging space.
These developments indicate a strategic evolution from single-target approaches to a more comprehensive platform-driven strategy, potentially reducing development risk through multiple mechanistic approaches and partnership support.
Advancement of next-generation APJ agonists with discontinuation of azelaprag
Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025
Expansion of discovery efforts based on insights from BioAge’s platform, including a target identification collaboration with Novartis and a newly announced antibody therapeutics development collaboration with Lilly ExploR&D
RICHMOND, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced company updates for its programs and platform.
• Advancement of next-generation APJ agonists with discontinuation of azelaprag
BioAge has terminated development of azelaprag, an orally available small molecule agonist of APJ, for obesity and other chronic diseases. The decision follows observations of liver transaminitis without clinically significant symptoms, and without clear dose dependence, in some patients in the azelaprag arms of the STRIDES Phase 2 clinical trial for obesity (link).
BioAge is developing structurally distinct APJ agonists in its pipeline, with the goal of nominating a development candidate by the end of 2025.
• Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025
BioAge is developing its novel, proprietary class of NLRP3 inhibitors, which have distinctive structural and biological properties and include molecules that penetrate the blood–brain barrier, for diseases associated with neuroinflammation. The Company has nominated a member of this class, the orally available, small-molecule brain-penetrant NLRP3 inhibitor BGE-102, as a development candidate. The structurally novel drug has potential best-in-class features, including high potency and high brain penetration, an important attribute for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity. IND-enabling experiments for BGE-102 are currently underway, and Phase 1 SAD data are anticipated by the end of 2025.
• Expansion of discovery efforts based on novel insights from BioAge’s platform, including collaborations with Novartis and Lilly
BioAge continues to leverage its discovery platform, which analyzes longitudinal human aging data to reveal the key molecular drivers of healthy aging to discover novel targets and molecules, via internal development programs and ongoing strategic collaborations.
In December, BioAge announced a multi-year research collaboration with Novartis to identify and validate novel therapeutic targets at the intersection of aging biology and exercise, combining BioAge's longitudinal human aging datasets with Novartis expertise in exercise biology. Under the terms of the agreement, BioAge will receive up to
BioAge has also entered a strategic collaboration with Lilly ExploR&D (part of Lilly Catalyze360) to discover two therapeutic antibodies that address novel metabolic aging targets identified by BioAge's discovery platform.
• Financial update
As of September 30, 2024, BioAge had approximately
About BioAge Labs, Inc.
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company’s pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel, structurally differentiated APJ agonists for metabolic disorders. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Forward-looking statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to anticipated preclinical and clinical development activities, timing of announcements of clinical results, trial initiation, and regulatory filings, potential benefits of the Company’s other product candidates and platform, the potential and timing of future milestone payments under the agreement with Novartis, and the current expected cash runway. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: BioAge’s ability to advance its product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, the Company’s commercial collaborations with third parties, the potential impact of global business or macroeconomic conditions, and the sufficiency of BioAge’s cash, cash equivalents and investments to fund its operations, and other factors discussed under the heading "Risk Factors" section of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other documents BioAge files from time to time with the Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of BioAge's management team and speak only as of the date hereof, and BioAge specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Dov Goldstein, ir@bioagelabs.com
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com
FAQ
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