Encouraging results for Amazentis’ anti-aging product candidate

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28.04.2017
Elderly

Amazentis’ product candidate Urolithin A holds promise for the management of age-related decline in muscle function. Data from a Phase 1 clinical trial confirm the biological activity of Urolithin A.

Amazentis announced today Phase 1 clinical data on the safety, bioavailability, and biological activity of its lead product candidate Urolithin A in a clinical trial in healthy elderly individuals. “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. Urolithin A (AMAZ-02) is planned to enter Phase 2 clinical testing during 2017.

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 goal is to manage health conditions linked to aging.

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.

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.”

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