BioAge Labs Files IPO Prospectus Highlighting Tirzepatide Combination Therapy for Fat Loss Without Muscle Loss

-Enterprise Perspective Issue 032-

BioAge is headquartered in California, USA., with approximately 90 employees.

BioAge Labs' AI platform is dedicated to identifying key mechanisms of human health and longevity and discovering drug targets for aging-related diseases. It is an in-depth analysis platform based on over 45 years of the human aging process, involving more than 10,000 patients and up to 65 million data points.

By analyzing health records in samples to study the human aging process over decades, it helps identify molecular mechanisms associated with healthy lifespan.

Each sample measures over 10,000 molecules, and high-throughput data collection provides powerful data support for understanding the human aging process.

Capable of mapping the aging process and identifying new drug targets, accelerating the translation of preclinical data into drug discovery and enhancing research efficiency.

Validate drug targets and molecules in naturally aging animal models to ensure that candidate drugs have a biological basis and therapeutic potential before entering clinical trials.

Develop new molecular entities through independent research and development or licensed引进.

Conduct acute disease clinical trials to improve the efficiency of translating R&D outcomes into clinical applications.。

Currently, BioAge's research mainly focuses on the field of combination therapies for weight loss drugs. In 2021, the company introduced Azelaprag, which was in Phase I clinical trials, from Amgen. This molecule is an orally available or intravenously injectable APJ agonist that mimics the activity of apelin. Apelin is a peptide hormone secreted during exercise, acting on skeletal muscles, the heart, and the central nervous system to regulate metabolism and promote muscle regeneration.

Phase Ib clinical data show that people treated with Azelaprag during bed rest experienced significantly less loss of thigh muscle mass compared to those on placebo, with a marked improvement in muscle physiology, promotion of muscle metabolism, and prevention of atrophy.

Preclinical studies show that the combination of Azelaprag and Tirzepatide enhances overall weight loss in tested mice compared to Tirzepatide alone. The Azelaprag group exhibited twice the weight loss and was able to restore body composition and muscle function to manageable levels. It is foreseeable that Azelaprag + Tirzepatide achieves a 1+1>2 effect: enhancing weight loss without muscle loss.

BioAge and Lilly are expected to officially launch a Phase II clinical trial for weight loss in mid-2024, combining azelaprag with Tirzepatide. The primary goal is weight reduction, with secondary goals focusing on other potential benefits, anticipating an average weight loss of 20%. BioAge will also collect information on aging-related biomarkers from participants.

In essence, BioAge's R&D strategy aligns with the goals pursued by the next generation of weight-loss drugs — healthy weight loss, reducing fat while minimizing muscle loss, allowing patients to maintain an ideal body mass index.

As of 2024-02-18, there are 220 global R&D pipelines targeting GLP-1, involving 154 companies and covering 107 indications; 158 of these are in clinical or later stages, accounting for 72% of all pipelines; in China, only 82 pipelines have entered the clinical or later stages, accounting for 37%, with overall progress lagging behind the global average.

Lilly, Novo Nordisk, AstraZeneca, Pfizer, Roche and other MNCs are continuously entering the GLP-1 weight loss track. Over 50% of the TOP20 MNCs have GLP-1 pipelines. How to stand out has become an unavoidable topic — some companies have already started combination therapies, and reducing fat without losing muscle is undoubtedly a clever development strategy.

BioAge currently has two main pipelines: its core pipeline is Azelaprag, which is pioneering an innovative combination therapy for fat reduction without muscle loss, and is expected to make waves in the weight-loss drug market. The other pipeline, BGE-100, is an NLRP3 inhibitor that can treat neurodegenerative diseases.

Previously, BioAge also had two anti-aging pipelines, BGE-117 and BGE-175, but both pipelines have been suspended.

In the prevailing trend of weight-loss drugs, the company wisely chose to adjust its strategic focus, concentrating all efforts into one breakthrough.

As competition in the weight-loss drug market intensifies, future focus may shift towards sustainable weight management rather than mere weight reduction—achieving fat loss while minimizing muscle loss to maintain an ideal Body Mass Index (BMI). This will be one of the goals for the next generation of weight-loss drugs.

While Semaglutide and Tirzepatide are selling well, they have exposed certain flaws, such as weight loss accompanied by muscle loss. Azelaprag from BioAge is precisely one of the solutions to this problem. With the rise of AI, combination therapies under the concept of healthy weight loss have once again brought BioAge to the forefront. It must be said that BioAge is a fortunate beneficiary of the times. Amidst the rush of capital investment and its partnership with Lilly, it holds great promise to create a remarkable success story.