Romainville, 26 August 2016, 08:00 – BIOPHYTIS (Alternext Paris: ALBPS), a biotechnology company specialized in development of drug candidates to treat aging diseases, announces the enrollment of the first volunteers in the pharmacokinetics study SARA-PK. The first step of the study will allow to compare pharmacokinetics and safety of Sarconeos, after escalating single dose administrations in elder and young healthy volunteers.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: “The start of the SARA-PK clinical study only four months after the Belgian Federal Agency for Medicines and Health Products’ (FAMHP, Belgian Drug Agency) scientific advice, demonstrates the responsiveness of Biophytis’ clinical development team. This study will potentially allow to adjust the two doses of Sarconeos that will be compared in the phase 2b international study, SARA-INT, to complete the clinical and regulatory filing and to start the study in 2017, as soon as the authorizations are granted in Europe and in the US.”
ABOUT THE SARA-PK STUDY: Approved by the Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp, the SARA-PK study will allow for qualification of pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). This study comprises two phases: the first to compare pharmacokinetics in elder and young healthy volunteers after escalating single dose administrations of Sarconeos; the second one to study pharmacokinetics and safety on elder healthy volunteers (30 volunteers) after daily administrations of Sarconeos for 14 days, at 3 doses. The results of the study will complete the clinical and regulatory file for Sarconeos, which is required for authorization to initiate the Phase IIb “SARA INT” clinical study, currently scheduled to start in the first half of 2017 in France, Belgium, Italy and USA.
ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people. This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide.
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About BIOPHYTIS:
Biophytis SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, Biophytis has discovered and begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing next year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre et Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: “The start of the SARA-PK clinical study only four months after the Belgian Federal Agency for Medicines and Health Products’ (FAMHP, Belgian Drug Agency) scientific advice, demonstrates the responsiveness of Biophytis’ clinical development team. This study will potentially allow to adjust the two doses of Sarconeos that will be compared in the phase 2b international study, SARA-INT, to complete the clinical and regulatory filing and to start the study in 2017, as soon as the authorizations are granted in Europe and in the US.”
ABOUT THE SARA-PK STUDY: Approved by the Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp, the SARA-PK study will allow for qualification of pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). This study comprises two phases: the first to compare pharmacokinetics in elder and young healthy volunteers after escalating single dose administrations of Sarconeos; the second one to study pharmacokinetics and safety on elder healthy volunteers (30 volunteers) after daily administrations of Sarconeos for 14 days, at 3 doses. The results of the study will complete the clinical and regulatory file for Sarconeos, which is required for authorization to initiate the Phase IIb “SARA INT” clinical study, currently scheduled to start in the first half of 2017 in France, Belgium, Italy and USA.
ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people. This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide.
****
About BIOPHYTIS:
Biophytis SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, Biophytis has discovered and begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing next year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre et Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute.
