Azelaprag

BioAge Labs has picked brain-penetrant molecule BGE-102 as its development candidate. \n BioAge Labs has given up on its lead obesity candidate. Weeks after stopping a trial in response to phase 2 data, the biotech has jettisoned the molecule and shifted its focus to a preclinical neuroinflammation prospect.California-based BioAge raised around $200 million in an IPO in September and swiftly reminded public investors that biotechs are risky bets. Two months after going public, BioAge stopped a phase 2 trial of its oral apelin receptor agonist azelaprag. Investors fled, but the biotech left the door open, noting that it remained encouraged by preclinical and early-phase data and vowing to share updated plans in 2025.BioAge closed the door on azelaprag Tuesday, explaining that the elevated liver enzymes seen in some patients without clear dose dependence had persuaded it to call time on the program. The biotech has structurally distinct molecules in its pipeline and aims to pick a follow-up candidate this year.With the apelin program bouncing back to preclinical, BioAge’s NLRP3 inhibitor has become the biotech’s most advanced prospect. Management has picked brain-penetrant molecule BGE-102 as its development candidate and is running studies to support a filing to test the asset in humans. BioAge expects to post phase 1 single-ascending dose data on the candidate this year. NLRP3 was a hot target as the 2010s drew to a close, when Bristol Myers Squibb, Novartis and Roche—both through its mothership and Genentech subsidiary—all acquired assets. None of the deals has led to an approved NLRP3 inhibitor.BioAge is initially focused on molecules that are active in the central nervous system. NodThera, Ventyx Biosciences, Roche and Ventus Therapeutics have all worked on similar molecules, but BioAge is bullish, with CEO Kristen Fortney, Ph.D., using a Citi event last month to claim the candidates are “an order of magnitude more potent than the competition.”The biotech’s focus on the neuroinflammatory uses of NLRP3 inhibition is built on longevity data linking the protein to accelerated cognitive aging and shorter life spans. BioAge also has evidence that inhibiting the protein could suppress appetite, suggesting there is scope to expand into obesity.Investors appeared to have priced in the pivot away from azelaprag, with the stock opening flat Tuesday. BioAge’s stock has fallen more than 75% since last year’s IPO, but the biotech has the money to write a second act—the company\'s cash runway extends beyond 2029. BioAge disclosed a collaboration with Lilly ExploR&D to discover two antibodies against metabolic aging targets identified by the biotech.

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 $20 million in upfront payments and research funding, plus up to $530 million in future long-term research, development, and commercial milestones (link). 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 $334.5 million in cash and cash equivalents. This amount is not inclusive of the additional $27.6 million net fees from the exercise of the IPO’s greenshoe option on October 1, 2024. Existing cash and cash equivalents extend cash runway beyond 2029. 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. ContactsPR: Chris Patil, media@bioagelabs.com IR: Dov Goldstein, ir@bioagelabs.com Partnering: partnering@bioagelabs.com Web: https://bioagelabs.com