Treatment with apelin receptor agonist enhanced glycemic control and demonstrated cardioprotective effects, with additive benefits observed in combination with incretin therapy

Data support development of next-generation APJ agonists for obesity and key comorbidities

EMERYVILLE, Calif., June 21, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ:BIOA) ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that it will present new preclinical data supporting apelin receptor (APJ) agonism for the treatment of diabetic obesity and heart failure with preserved ejection fraction (HFpEF). The data will be presented at the American Diabetes Association's 85th Scientific Sessions, held June 20–23, 2025, in Chicago, Illinois.

"Our preclinical data demonstrated that APJ activation can confer multiple benefits in models of diabetic obesity and heart failure, and enhance the effects of incretin therapy," said Kristen Fortney, PhD, CEO and co‑founder of BioAge. "We are advancing next‑generation APJ agonists to translate this promising biology into new therapies for obesity and its major comorbidities."

APJ is the receptor for apelin, an exercise-induced signaling molecule known as an exerkine. Apelin has been shown in preclinical studies to have the potential to recapitulate many of the downstream benefits of exercise. BioAge's discovery platform identified apelin signaling as a therapeutic target based on analysis of human aging cohorts, which revealed that higher levels of circulating apelin are predictive of improved physical function and increased longevity. BioAge has shown that in preclinical obesity models, APJ agonism can approximately double the weight loss induced by GLP-1 receptor agonists while restoring body composition and muscle function, suggesting that APJ agonists could serve as pharmacological exercise mimetics to enhance incretin therapy.

BioAge is advancing multiple APJ agonist approaches, including both oral small-molecule and long-acting injectable formulations, with an IND filing targeted for 2026 [link].

In their two presentations, BioAge CMO and EVP Research Paul Rubin, MD, and scientist Shijun Yan, PhD, MBA, will present data that demonstrated that in preclinical models of diabetic obesity and HFpEF, APJ agonist treatment had potential as monotherapy that could be enhanced in combination with incretin therapies.

Enhanced glycemic control in diabetic obesity — Dr. Rubin's oral presentation will show that in mouse models of diabetic obesity, APJ agonist monotherapy reduced HbA1c to levels comparable to lean controls and improved glucose tolerance by 25%. When combined with an incretin, APJ agonism further improved glycemic control compared to the incretin alone. Currently, fewer than half of patients with type 2 diabetes achieve optimal glycemic control on current incretin therapies.
Cardioprotective effects in HFpEF — Dr. Yan's poster will show that in a mouse model of obesity-associated heart failure, APJ agonist monotherapy reduced cardiac hypertrophy and suppressed markers of cardiac injury. Combination of APJ agonism with an incretin provided enhanced cardioprotective benefits and greater weight loss compared to either treatment alone. Over half of heart failure patients have preserved ejection fraction, and approximately two-thirds of these patients have obesity. Current therapeutic options for obesity-associated HFpEF remain limited.

Oral presentation: Saturday Jun 21, 2025 5:00 PM - 5:15 PM CDT

Title: An Oral Apelin Receptor Agonist Enhances Glycemic Control in Preclinical Models of Diabetic Obesity Both as Monotherapy and in Combination with Tirzepatide

Session: Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials Testing Incretin-Based Therapies—Take 1; W181 A-C

Presenter: Paul Rubin, MD, Chief Medical Officer and EVP-Research

Poster presentation: Sunday Jun 22, 2025 12:30 PM - 1:30 PM CDT

Title: The Apelin Receptor Agonist Azelaprag Shows Cardioprotective Effects as Monotherapy and Enhanced Benefits with Semaglutide in a Diet-Induced Obesity Model of Heart Failure with Preserved Ejection Fraction

Session: Poster Hall F1, Board No. 866

Presenter: Shijun Yan, PhD, MBA, Senior Scientist, In Vivo Biology

The visual materials for the presentations will be made available on the BioAge investor website https://ir.bioagelabs.com concurrent with the beginning of their respective sessions.

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 lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for obesity. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. IND submission and initiation of a Phase 1 SAD/MAD trial are planned for mid-2025, with initial SAD data anticipated by end of year. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. 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

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, including BGE-102 and our APJ program, the timing and results of our planned clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of our IND filing for BGE-102 or our APJ program, our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates or their ultimate ability to treat human disease, the expected timeline for completing proteomic analysis, anticipated analytical results and the potential for identifying novel therapeutic targets, and general economic, industry and market conditions. 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, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; 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 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025, and BioAge's 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: Dov Goldstein, ir@bioagelabs.com

Partnering: partnering@bioagelabs.com

Web: https://bioagelabs.com

BioAge Labs to Present Preclinical Data on APJ Agonism for Diabetic Obesity and Heart Failure at the American Diabetes Association (ADA) 85th Scientific Sessions