BioAge Labs Halts Clinical Trial for Azelaprag Amid Safety Concerns

BioAge Labs Discontinues Azelaprag Trial

BioAge Labs, a clinical-stage biopharmaceutical company dedicated to developing therapies targeting metabolic diseases through understanding human aging, has made the significant decision to discontinue its STRIDES Phase 2 clinical trial involving azelaprag. This decision arose after the observation of liver transaminitis in certain participants receiving the investigational drug, despite them not exhibiting clinically significant symptoms.

Focus on Patient Safety

In a statement, Kristen Fortney, PhD, the CEO and co-founder of BioAge, emphasized that the well-being of study participants is paramount. She remarked, "We made the difficult decision to discontinue the STRIDES Phase 2 study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy." While discontinuation is disheartening, the company remains optimistic about the promising preclinical and Phase 1b efficacy profiles of azelaprag.

Future Direction for Azelaprag

BioAge is now set to analyze the data collected from the patients involved thus far and plans to share updated strategies for azelaprag in the coming months. The company also aims to attract further interest in its other pipeline projects targeting metabolic aging.

Understanding the STRIDES Clinical Trial

STRIDES was specifically designed as a randomized, double-blind, placebo-controlled trial. Its purpose was to evaluate azelaprag as a monotherapy as well as its effectiveness in combination with tirzepatide, targeting individuals over 55 years affected by obesity. The trial aimed to evaluate the drug's impact on weight reduction and assess safety and tolerability through two oral doses of azelaprag in conjunction with a weekly injection of tirzepatide.

Current Status of the Trial

As of now, 204 participants had been enrolled in the STRIDES trial. Of these, 11 individuals presented with transaminase elevations during treatment, although none of them exhibited significant clinical symptoms. Effective immediately, dosing for all participants has been halted, and no further individuals will be recruited into the study. Nonetheless, clinical follow-ups for those previously enrolled will continue.

Ongoing Research Programs

Despite this setback with azelaprag, BioAge remains committed to advancing its therapeutic pipeline. The company is focusing on developing a novel class of brain-penetrant NLRP3 inhibitors. These have shown significant potency in addressing neuroinflammation linked to metabolic and neurodegenerative diseases. With an IND submission for this promising NLRP3 inhibitor anticipated later this year, BioAge is poised to continue its research endeavors.

About BioAge Labs

Founded to tackle the pressing challenges of metabolic diseases and aging, BioAge Labs seeks to develop impactful therapies against conditions such as obesity. Through innovative products like azelaprag and novel insights gleaned from its proprietary discovery platform, the company is dedicated to comprehensively analyzing human aging data. Its approach reveals key mechanisms impacting metabolic aging, guiding the development of new treatments.

Frequently Asked Questions

1. Why did BioAge Labs discontinue the STRIDES trial?

The trial was halted due to the observed liver transaminitis in some participants receiving azelaprag, raising safety concerns despite the absence of clinically significant symptoms.

2. What will happen to the participants of the STRIDES trial?

All dosing for trial participants has been suspended, but clinical follow-up will continue for those already enrolled to monitor their health.

3. What are the future plans for azelaprag?

BioAge intends to analyze the current data from trial participants and will outline its updated plans concerning azelaprag early next year.

4. What other research initiatives is BioAge pursuing?

In addition to azelaprag, BioAge is developing a new class of NLRP3 inhibitors targeting neuroinflammation and other metabolic diseases.

5. How does BioAge Labs approach the problem of aging?

BioAge employs a unique discovery platform that analyzes over 50 years of human aging data to guide the development of therapies targeting metabolic diseases, particularly those arising from aging.

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