BioAge Labs, Inc.—a company focused on the development of therapeutics for metabolic diseases—announced an ophthalmic expansion of its lead clinical program into diabetic macular edema (DME).
The move also coincides with BioLab proposing an underwritten public offering of up to $75 million in common stock to financially support this expansion.
Lots to unpack here … but let’s start this company.
Headquartered in Emeryville, California, BioAge has operated as a clinical-stage biopharmaceutical company for the last 10+ years, targeting the “biology of human aging.”
Specifically: The company is developing small molecules and biologics for metabolic diseases (such as obesity, cardiovascular [CV], and cardiometabolic).
How it’s doing this: Via a proprietary discovery platform that adopts a “data-first,” unbiased approach to metabolic aging by identifying translational drug targets of new and existing biology.
- The platform encompasses > 65 million molecular measurements spanning 45+ years of human aging (see here for its features).
And BioAge’s lead asset?
That would be BGE-102, a potent and oral brain-penetrant small molecule NLRP3 inhibitor with a reportedly unique mechanism of action (MOA) and binding site.
- Take note: As a protein involved in the body’s innate immune system, NLRP3 has a reputation for being a driving force behind age-related inflammation in conditions such as CV disease, neurodegeneration, and metabolic disorders.
As for its clinical efficacy: Just last month the company reported positive interim phase 1 data from a single-ascending dose (SAD) and multiple-ascending dose (MAD) study for CV risk factors.
- Check out the initial findings supporting its favorable safety profile and major impact in reducing key inflammatory biomarkers.
So how does this factor into a new ophthalmic focus?
Circling back to NLRP3: BioAge describes inflammation activation of this protein as a “central pathological feature in a range of retinal diseases."
Among these: DME, where NLRP3 activation (via hyperglycemia) can result in vascular leakage and impaired vision.
And with that in mind …
The company noted that DME represents an initial “proof-of-concept” indication for BGE-102’s entry into the ophthalmic treatment space—with the potential for future targeting of other retinal diseases like geographic atrophy (GA).
And in the words of co-founder and CEO Kristen Fortney, PhD:
- “BGE-102 offers the potential to deliver broader anti-inflammatory benefit in an oral formulation, which could meaningfully reduce treatment burden for patients with serious, sight-threatening conditions who currently require frequent intravitreal injections.”
They sure sound confident about BGE-102’s capabilities …
Indeed. And that’s largely based on preclinical evidence supporting the oral asset’s potential for “therapeutic retinal exposure,” as BioAge put it, when evaluated for DME.
More precisely, BGE-102 reportedly:
- Demonstrated “dose-dependent preservation of retinal vascular integrity”
- Achieved near-completion protection from vascular leakage
- Preserved up to 90% of microvascular integrity
And looking specifically at NLRP3: See here for additional research supporting how deleting or inhibiting NLRP3 results in “complete protection of the retinal pigment epithelium against pro-inflammatory challenges”—among other promising data.
So! What’s the first step for this new DME program?
BioAge is gearing up to initiate a phase 1b/2a proof-of-concept (POC) trial later this year.
What we know so far: The randomized controlled trial (RCT) will evaluate DME patients across three arms to determine BGE-102’s efficacy as a potential monotherapy and in combination with a vascular endothelial growth factor (VEGF) inhibitor.
- Its goal: To demonstrate the oral asset’s target engagement and pharmacodynamics in the eye, with the intent to encourage “future clinical development in retinal diseases driven by inflammation,” per BioAge.
And what will be measured?
The primary endpoint: Percentage change in intraocular interleukin (IL)-6 (a key inflammatory cytokine located in the eye).
Additional exploratory endpoints are expected to include:
- Best-corrected visual acuity (BCVA)
- Central subfield thickness (CST)
- Intraocular and plasma biomarkers
Lastly: When can we expect a data readout?
Sometime in mid-2027.
Check out the candidate’s full anticipated clinical milestones over the next 2 years.