HitGen Partner BioAge Labs Initiates Phase 1 Clinical Study of BGE-102, a Novel Brain-Penetrant NLRP3 inhibitor

Rhea-AI Summary

BioAge Labs (NASDAQ:BIOA) has initiated a Phase 1 clinical study of BGE-102, a novel brain-penetrant NLRP3 inhibitor developed in collaboration with HitGen (SSE:688222). The drug candidate, discovered using HitGen's DNA-encoded library (DEL) technology platform, is being developed initially for obesity treatment.

BGE-102 is an orally available small molecule that targets NLRP3, a key driver of age-related inflammation implicated in neurodegenerative conditions, cardiovascular disease, and metabolic disorders. The clinical trial initiation triggers an undisclosed milestone payment to HitGen under their collaboration agreement.

The partnership, which began with successful hit identification in April 2021, has resulted in joint patent filings and a published research paper in February 2024. Both companies continue to collaborate on additional drug discovery programs using HitGen's DEL platform, which contains over 1.2 trillion small molecules.

Positive

• Successful advancement of BGE-102 to Phase 1 clinical trials
• Milestone payment triggered for HitGen
• Novel drug candidate with potential applications in multiple diseases
• Continued collaboration between companies for additional drug discovery programs
• Joint patent filings secured for the discovered compounds

Negative

• Milestone payment amount remains undisclosed
• Early-stage clinical development with uncertain outcomes

Insights

Biotechnology Research Analyst

HitGen's DEL platform demonstrates value with BioAge's BGE-102 entering clinical trials, triggering milestone payment and validating their partnership model.

This milestone represents a significant validation of HitGen's DNA-encoded library (DEL) technology platform. The advancement of BGE-102 into Phase 1 clinical trials demonstrates the platform's ability to identify novel small molecule compounds against challenging targets like NLRP3, a key inflammation driver implicated in multiple age-related conditions.

The triggered milestone payment (amount undisclosed) provides immediate financial benefit to HitGen while showcasing their successful partnership model. This approach allows HitGen to monetize their technology through collaborations rather than bearing the full risk of drug development themselves.

BGE-102's profile is particularly promising - it's orally available with high potency and brain penetration, initially targeting obesity but with potential applications across neurodegenerative, cardiovascular, and metabolic disorders. The compound's novel structure and binding mechanism (documented in their February 2024 joint publication) suggests differentiation from existing NLRP3 inhibitors.

The companies have secured intellectual property through joint patent filings, creating a sustainable competitive advantage. With HitGen's platform now containing over 1.2 trillion small molecules, this success story strengthens their position as a premier early-stage drug discovery partner, potentially attracting more high-value collaborations and milestone-generating partnerships.

• BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technology platform, highlighting the value of DEL to accelerate innovative drug development.
• The initiation of the BGE-102 Phase 1 clinical study triggers a milestone payment to HitGen.

CHENGDU, China, Sept. 15, 2025 /PRNewswire/ -- Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH), congratulates its partner BioAge Labs, Inc. ("BioAge", NASDAQ: BIOA), a clinical-stage biotechnology company based in Emeryville, CA, USA, on the initiation of a Phase 1 clinical study of BGE-102, a novel, potent NLRP3 inhibitor developed from a hit compound identified using HitGen's industry-leading DEL technology platform. The event triggers an undisclosed milestone payment to HitGen under the collaboration agreement between the two companies.

BGE-102 is a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for the treatment of obesity. NLRP3 is a key driver of age-related inflammation that has been implicated in a broad range of diseases, including neurodegenerative conditions and cardiovascular disease as well as metabolic disorders such as obesity. BioAge identified NLRP3 as a therapeutic target for metabolic and age-related diseases and sought to develop novel inhibitors, leading to the successful collaboration with HitGen.

BGE-102 was developed by BioAge from hit compounds identified in a screen using HitGen's DEL libraries under a collaboration agreement between the parties. In April 2021, the companies announced the successful identification of promising hit molecules. In February 2024, the companies further detailed their research collaboration outcome in a joint publication in Bioorganic & Medicinal Chemistry Letters, entitled "The discovery of novel and potent indazole NLRP3 inhibitors enabled by DNA-encoded library screening". The collaboration has also resulted in joint patent filings covering the structurally novel compounds discovered through the DEL screening process. BioAge and HitGen continue to collaborate on additional drug lead discovery programs for other novel targets using HitGen's DEL platform.

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc., stated: "We extend our congratulations to the BioAge team on this exciting progress. The advancement of BGE-102 into clinical studies not only validates the power of HitGen's DEL platform to discover novel small molecules against challenging targets, but also reinforces the value of our partnership model. We look forward to continuing our collaboration and following the development of this promising candidate."

"We're excited to reach this important clinical milestone with BGE-102," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "HitGen's DEL platform helped us identify structurally distinct NLRP3 inhibitors with a novel binding site and strong potency and brain penetration. Our collaboration demonstrates the value of combining HitGen's cutting-edge screening technology with insights from human aging biology to advance potentially transformative treatments for metabolic diseases."

HitGen is a world leader in the development of DEL technology and applications to early-stage small molecule drug discovery. Its platform includes over 1.2 trillion small molecules generated by the DEL technology, and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations around the world.

About HitGen Inc.

HitGen Inc. (SSE: 688222.SH), is a drug discovery research company headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid-based drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for oligonucleotide-based therapeutics (OBT), and targeted protein degradation technology (TPD). Meanwhile, we are developing a DEL+AI+Automated DMTA (Design-Make-Test-Analyze) molecular optimization platform to accelerate the discovery and optimization process of preclinical candidate compounds. Through our diverse and flexible business models, we have built up collaboration partnerships with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage.

About BioAge Labs, Inc.

BioAge (NASDAQ: BIOA) 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. A Phase 1 SAD/MAD trial of BGE-102 is underway, 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.

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SOURCE HitGen Inc.

FAQ

What is BGE-102 and what is it being developed for by BioAge Labs?

BGE-102 is a novel, brain-penetrant NLRP3 inhibitor being developed initially for obesity treatment. It's an orally available small molecule that targets age-related inflammation.

What milestone did BioAge Labs (NASDAQ:BIOA) achieve with BGE-102 in September 2025?

BioAge Labs initiated a Phase 1 clinical study of BGE-102, triggering a milestone payment to their development partner HitGen.

How was BGE-102 discovered by BioAge and HitGen?

BGE-102 was discovered using HitGen's DNA-encoded library (DEL) technology platform, which contains over 1.2 trillion small molecules. The initial hits were identified in April 2021.

What diseases could BGE-102 potentially target?

BGE-102 targets NLRP3, which is implicated in multiple conditions including obesity, neurodegenerative conditions, cardiovascular disease, and other metabolic disorders.

What results have come from the BioAge-HitGen collaboration?

The collaboration has produced a Phase 1 clinical candidate (BGE-102), joint patent filings, a research publication in February 2024, and continues with additional drug discovery programs.