BioAge Announces First Patient Dosed in the STRIDES Phase 2 Clinical Trial Evaluating Azelaprag as a Novel Treatment for Obesity in Combination with Tirzepatide
2024年7月29日 - 9:00PM
ビジネスワイヤ(英語)
Trial to evaluate weight loss efficacy of azelaprag, an oral
small molecule apelin receptor agonist that mimics key biological
effects of exercise
STRIDES is being conducted in collaboration with Lilly’s Chorus
clinical development organization
Primary endpoint is weight loss at 24 weeks, with exploratory
endpoints including body composition and physical activity
BioAge Labs, Inc., ("BioAge"), a clinical-stage
biopharmaceutical company developing therapeutic product candidates
for metabolic diseases by targeting the biology of human aging,
today announced that the first patient has been dosed in the
STRIDES Phase 2 clinical trial evaluating BioAge’s lead product
candidate azelaprag in combination with tirzepatide for the
treatment of obesity in adults aged 55 and older.
Azelaprag is an orally available small molecule agonist of the
apelin receptor APJ. Apelin is an exercise-induced signaling
molecule (exerkine) that acts on APJ to mediate many of the
metabolic benefits of physical activity. In a Phase 1b clinical
trial in healthy older volunteers on 10 days of bed rest, azelaprag
was observed to improve muscle metabolism, decrease muscle atrophy,
and preserve measures of resting energy expenditure and
cardiorespiratory fitness (link). Azelaprag has been well tolerated
in more than 240 subjects across seven Phase 1 clinical trials to
date. In mouse models of obesity, the addition of azelaprag
approximately doubled the weight loss achieved with incretin drugs
(GLP-1 receptor agonists) while restoring healthy body composition
and physical function (link).
“We believe combining azelaprag, an exercise mimetic, with
tirzepatide, a GLP-1/GIP receptor agonist that decreases food
intake, could provide a powerful pharmacological parallel to the
exercise and diet interventions that form the foundation of obesity
management,” said Kristen Fortney, PhD, CEO and co-founder of
BioAge. “The STRIDES trial aims to demonstrate that activating
apelin signaling with azelaprag is a potent complementary mechanism
that can deliver increased weight loss efficacy in patients on
incretins. In addition, this trial will provide a direct
read-through to azelaprag’s potential as an orally available small
molecule to achieve efficacy on par with injectable weight loss
drugs when combined with incretins in an all-oral regimen."
STRIDES is a randomized, double-blind, placebo-controlled Phase
2 clinical trial of azelaprag in combination with tirzepatide that
will enroll approximately 220 obese individuals aged 55 years and
older. The trial will evaluate the efficacy, 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). The primary endpoint is mean percent change in body
weight at 24 weeks. Additional exploratory endpoints include body
composition, glycemic control, obesity-related biomarkers, and
patient-reported outcomes related to health and quality of life.
Top-line results are anticipated in the fourth quarter of 2025.
STRIDES is being conducted in collaboration with Eli Lilly and
Company’s (Lilly) Chorus clinical development organization. Lilly
is providing tirzepatide for the trial (link).
A second planned Phase 2 clinical trial will assess azelaprag in
combination with semaglutide (Wegovy®) with initiation expected in
the first half of 2025. Together, the trials will seek to support
BioAge’s therapeutic goal of developing an all-oral combination
product for obesity.
About BioAge Labs
BioAge is a clinical-stage biopharmaceutical company developing
therapeutic product candidates for metabolic diseases, such as
obesity, by targeting the biology of human aging. BioAge’s lead
product candidate, azelaprag, is an orally available small molecule
agonist of APJ that was observed to promote metabolism and prevent
muscle atrophy on bed rest in a Phase 1b clinical trial. In
mid-2024, BioAge initiated a Phase 2 trial of azelaprag in
combination with tirzepatide for the treatment of obesity in older
adults. Azelaprag has potential as an oral regimen to amplify
weight loss and improve body composition in patients on obesity
therapy with incretin drugs. BioAge is also developing orally
available small molecule brain penetrant NLRP3 inhibitors for the
treatment of diseases driven by neuroinflammation. BioAge’s
preclinical programs, based on novel insights from the company’s
discovery platform built on human longevity data, also address key
pathways in metabolic aging.
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