BioAge kicks off Phase 2 longevity clinical trial

Company reveals primary indicator for BGE-117 clinical trial is unexplained anaemia of aging.

Hot on the heels of its monster $90 million Series C funding round at the end of last year, longevity biotech company BioAge Labs has announced the start of a Phase 2a clinical trial of its BGE-117 for unexplained anaemia of aging (UAA).

The multi-centre, randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of BGE-117 in elderly patients with UAA. The compound will be administered daily for 12 weeks, with top-line results expected in the first half of 2022.

Longevity.Technology: When we spoke with BioAge co-founder and CEO Kristen Fortney recently, she told us that the company would soon reveal the primary indication for BGE-117. Now we know that indication is UAA, a debilitating condition affecting 10% of people over the age of 65 and 25% of those over 85. Yet more exciting news for our sector – we’ll be following the progress of this trial with great interest…

BioAge co-founder and CEO, Kristen Fortney

UAA is a form of anaemia affecting older people that cannot be attributed to iron deficiency or underlying medical conditions. Patients with UAA have diminished quality of life due to fatigue, reduced mobility and loss of independence. In addition, they are at greater risk of falling, are hospitalised more often and with longer stays, and experience overall mortality three to four times higher than non-anaemic people of comparable age.

“UAA is both highly prevalent and highly morbid, dramatically decreasing quality of life in its patients and imposing a tremendous pharmacoeconomic burden,” said Fortney in a statement.

“The lack of safe and effective treatments for this condition represents a major unmet clinical need.”

In this randomised, placebo-controlled, double-blind, multi-centre Phase 2a trial, 160 UAA patients 65 years or older will receive daily oral doses of BGE-117 or a placebo.

The trial is being conducted in Australia, with approximately 15 sites expected to participate. The primary endpoints of the trialare haemoglobin levels and patient-reported scores on the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale, a 40-item assessment of fatigue and its impact on daily activities and function. In parallel, the study will collect data on safety and pharmacokinetic/pharmacodynamic (PK/PD) parameters. In addition, BioAge will collect data about aging biomarkers and exploratory muscle aging endpoints.

“We already know from Phase 1 trials that our drug improves EPO and Hb levels in patients who do not have UAA, and this is a primary endpoint for our Phase 2 trial,” said Fortney. “The study is therefore well suited to BioAge’s strategic approach of in-licensing de-risked clinical-stage assets.”

The importance of HIF signalling

BGE-117 is an orally administered small molecule that inhibits HIF prolyl hydroxylase (HIF PH). This activates hypoxia-inducible factor (HIF), a key transcription factor in the cellular response to low levels of oxygen.

Activation of HIF signalling improves oxygen delivery and has the potential to increase resilience, repair, and regeneration across multiple tissues and organs. By analysing data harvested from its proprietary biobank platform, BioAge discovered that people with higher HIF activity have higher physical and cognitive function and are significantly more likely to live to 85 or beyond, revealing a strong connection between longevity and HIF signalling.

“BGE-117 … holds great promise for several acute and chronic conditions driven by muscle aging …”

As Fortney previously told us, BioAge believes that BGE-117 has the potential to treat multiple diseases of aging by boosting diverse biological processes controlled by HIF’s target genes, including erythropoiesis, glycolysis, glucose uptake, vascular remodelling and angiogenesis.

“Because BGE-117 targets a critical pathway that is dysregulated as we age, it holds great promise for several acute and chronic conditions driven by muscle aging,” she said. “Functional and biomarker data from this trial will guide our advancement of BGE-117 into additional indications, targeting multiple diseases of aging with large unmet needs, high prevalence, and huge markets.”

Images courtesty of BioAge Labs