Amazentis SA Announces Successful Phase 1A/1B Study Results in Healthy Elderly Subjects with the Food Metabolite Urolithin A
April 27 2017 - 3:00AM
Business Wire
Oral presentation at the International
Conference on Frailty and Sarcopenia Research in Barcelona to
report the successful achievement of Phase 1 study’s primary and
secondary objectives
Clinical data confirm biological activity of
Urolithin A on human skeletal muscle mitochondria
Amazentis SA, an innovative life sciences company pioneering
scientific breakthroughs in nutrition to manage health conditions
linked to aging, announced today Phase 1 clinical data on the
safety, bioavailability, and biological activity of Urolithin A in
a double-blind, randomized, placebo-controlled clinical trial in
healthy elderly individuals. The study consisted of two parts, a
single ascending dose (part A), followed by a multiple ascending
dose for a period of 4 weeks (part B). These data are scheduled to
be presented at the International Conference on Frailty and
Sarcopenia Research (ICFSR) taking place in Barcelona, Spain, April
27-29, 2017.
The clinical findings demonstrated:
- Achievement of the Phase 1A/1B study’s
primary safety endpoint; no serious and no product-related
non-serious adverse events were reported during the conduct of
parts A and B;
- Bioavailability of Urolithin A in blood
and skeletal muscle;
- Upregulation of mitochondrial gene
expression in elderly skeletal muscle tissue during part B;
and
- Decrease of the plasma acylcarnitine
metabolites during part B
“We are pleased to report these first clinical data that
demonstrate both the safety of Urolithin A and the translation of
its biological effects to elderly human subjects. Urolithin A holds
promise for the management of age-related decline in mitochondrial
and skeletal muscle function, for which there are currently no
pharmaceutical therapies and where nutritional strategies have had
limited impact to date,” commented Chris Rinsch, PhD, CEO and
co-founder of Amazentis.
“It's exciting to see that orally administered Urolithin A is
increasing mitochondrial gene expression in human muscle tissue
following a 4-week treatment,” commented Johan Auwerx, MD,
PhD, Professor at the École Polytechnique Fédérale de Lausanne
(EPFL), Switzerland. “Combined with the lowering of plasma
acylcarnitines, this is the first evidence that Urolithin A
stimulates mitochondria in the muscle of humans and is consistent
with our earlier preclinical observations, which
demonstrated that such molecular changes were coupled to
enhanced muscle function.”
Phase 1 study of first-in-class natural bioactive to improve
mitochondrial and muscle function in the elderly
Amazentis’ Phase 1 study of Urolithin A (AMAZ-02) was a
single-center, multi-part (single and multiple ascending doses)
double-blind, randomized, placebo-controlled study in 60 healthy
elderly subjects. Part A of the Phase 1 study involved orally
administering single escalating doses (250mg, 500mg, 1000mg, and
2000mg). During Part B, 250mg, 500mg, and 1000mg were selected for
4 weeks of daily oral dosing and their impact on skeletal muscle
mitochondrial biomarkers was investigated along with safety and
bioavailability. Additional information on the clinical trial
design is available on clinicaltrials.gov.
All doses were observed to be safe and bioavailable. No serious
and no product-related non-serious treatment emergent adverse
events were recorded during the conduct of the Phase 1 human study.
The impact of Urolithin A on plasma and muscle biomarkers following
4-week multiple ascending dosing were assessed, revealing that
Urolithin A intake significantly modulated both gene expression and
plasma metabolites linked to mitochondrial and muscle function.
These key clinical results will be reported in an oral
presentation titled, “Orally administered Urolithin A is safe and
modulates muscle and mitochondrial biomarkers in a randomized,
double-blind, placebo controlled Phase 1 clinical trial in
elderly,” at the ICFSR conference on April 28, 2017, at 5:45pm
CEST.
Results of a second, non-interventional study conducted by
Amazentis revealed the strong link between low mobility status in
elderly and declining mitochondrial function in skeletal muscle.
These results will also be reported in an oral presentation titled,
“Mitochondrial dysfunction as a driver for age related muscle
decline and frailty syndrome: A clinical study comparing active
versus pre-frail elderly,” also taking place on April 28, 2017, at
4:45pm CEST. Abstracts of these presentations will also be
published in a special edition of the scientific review The Journal
of Frailty & Aging.
“The positive advancement of our clinical research program
highlights the promise of Urolithin A and its potential health
benefits driven by the strong underlying science,” explained
Patrick Aebischer, MD, Chairman of Amazentis and Professor at the
EPFL. “These results set the stage for Phase 2 clinical studies
featuring a longer intervention period and designed to assess the
impact of Urolithin A on muscle and mitochondrial function in the
healthy elderly population.”
About Urolithin A (AMAZ-02)
Amazentis lead product is AMAZ-02, a proprietary form of
Urolithin A, a naturally occurring metabolite that has been shown
to improve mitochondrial and muscle function through a process
known as mitophagy. These findings were published in a
peer-reviewed article titled, “Urolithin A induces mitophagy and
prolongs lifespan in C. elegans and increases muscle function in
rodents” (doi:10.1038/nm.4132), which appeared last year in Nature
Medicine and featured key findings from preclinical research
conducted in collaboration with Prof. Auwerx's laboratory.
About Amazentis
Amazentis SA is a life science company that employs today’s
leading research and clinical science to develop the next
generation of bioactive ingredients derived from nature for
advanced therapeutic nutrition products. The Company’s lead product
candidate, AMAZ-02, an oral formulation of Urolithin A, is planned
to enter Phase 2 clinical testing during 2017. For more
information, please visit www.amazentis.com
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Amazentis SAChris Rinsch, Ph.D.CEO & Co-Founder, Amazentis
SAcontact@amazentis.comorFor Media Inquiries:Burns McClellanJustin
Jackson, 212-213-0006, ext. 327jjackson@burnsmc.com