BioAge Labs (BIOA) stops Eli Lilly-collaborated obesity trial on safety concerns

• In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of 2025.

 

On Friday, BioAge Labs Inc. (NASDAQ:BIOA) announced that it will discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate, azelaprag.

STRIDES was being conducted in collaboration with Eli Lilly And Co’s (NYSE:LLY) Chorus clinical development organization. Top-line results were anticipated in the third quarter of 2025.

The move follows after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag.

STRIDES is a Phase 2 clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enroll approximately 220 individuals with obesity aged 55 years and older.

Tirzepatide is an active ingredient of Eli Lilly’s popular Zepbound and Mounjaro.

The trial was designed to evaluate the efficacy as measured by body weight reduction and other outcomes, safety, and tolerability of two oral doses of azelaprag (300 mg, once or twice daily) in combination with tirzepatide (5 mg subcutaneous injection once weekly).

An azelaprag monotherapy arm was included to provide additional safety information.

The company said no transaminase elevations were observed in the tirzepatide only treatment group.

Of 204 subjects enrolled in STRIDES, 11 subjects in the azelaprag treatment groups were observed to have transaminase (liver enzymes) elevations with no clinically significant symptoms. Dosing of all subjects will be discontinued, and no additional subjects will be enrolled.

Clinical follow-up of enrolled subjects will continue off-drug. The company intends to further analyze available STRIDES clinical data from all enrolled subjects and share updated plans for azelaprag in the first quarter of 2025.

The company’s brain-penetrant NLRP3 inhibitors are progressing toward IND submission, anticipated in the second half of 2025. The NLRP3 inhibitor program targets neuroinflammation linked to metabolic and neurodegenerative diseases.

As of September 30, BioAge had approximately $334.5 million in cash and cash equivalents, which is expected to be sufficient to fund operations and capital expenses into 2029.

In October, BioAge Labs closed its upsized initial public offering of 12.65 million shares at $18 per share.

Xilio Therapeutics (XLO) : 3-year performance

Xilio Therapeutics, Inc., a clinical-stage biotechnology company, engages in the discovery and development of tumor-activated immuno-oncology therapies. 

• Sector: Healthcare
• Industry: Biotechnology
• Full Time Employees: 73
• Founded in 2016 
• Headquartered in Waltham, Massachusetts
• https://xiliotx.com

Ticker: XLO

October 22, 2021 : initial public offering of 7,353,000 shares of its common stock at a price to the public of $16.00 per share. 

 

 

 

Fulcrum Therapeutics (FULC) : Topline Results from Phase 3 REACH Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

― Losmapimod failed to show an improvement in relative surface area (RSA), a measure of reachable workspace (RWS), versus placebo at week 48 

― Fulcrum to suspend future losmapimod development 

― Robust cash position enables Fulcrum to continue its mission to develop therapies addressing diseases of high unmet need including pociredir for the treatment of sickle cell disease (SCD)

 

 

 

 

 

 

 

Fulcrum Therapeutics is a biopharmaceutical company that focuses on developing small molecule therapies to treat rare diseases. The company was founded in Cambridge, Massachusetts in July 2016 by Third Rock Ventures.
It went public on July 17, 2019.

About the REACH Trial
REACH (NCT05397470) is a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of losmapimod for the treatment of FSHD. The trial enrolled 260 patients who were randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or placebo over a 48-week treatment period. The primary endpoint was the absolute change from baseline in Reachable Workspace (RWS). Secondary endpoint measurements included Muscle Fat Infiltration (MFI) as measured by MRI, shoulder abductor strength as measured by hand-held dynamometry, Patient Global Impression of Change (PGIC), and the Neuro QoL Upper Extremity.

About FSHD
FSHD is a serious, rare, progressive and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving primarily the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes relentless and accumulating muscle and functional loss impacting their ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence, and chronic pain. FSHD is one of the most common forms of muscular dystrophy and has an estimated patient population of 30,000 in the United States alone.