BIOPHYTIS Receives Belgian Regulatory Authorization To Start Sarconeos Pharmacokinetics Study In Elderly Healthy Volunteers (SARA-PK)
Romainville, 25 July 2016, 18:00 – BIOPHYTIS (Alternext Paris: ALBPS), a biotechnology company specialized in development of drug candidates to treat aging diseases, today announces thatthe Belgian regulator authorized the planned pharmacokinetics study of its lead product, Sarconeos (SARA-PK study), which is in development to treat sarcopenic obesity.
The Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp gave their authorization regarding the initiation of the SARA-PK study to qualify pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). This study will be conducted during the second half of 2016 in two phases: the first phase will compare pharmacokinetics in elder and young volunteers after escalating single dose administrations of Sarconeos; the second phase will 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.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: “The authorization from Belgian health authorities to initiate the SARA-PK study is an important step in the development of the first treatment for sarcopenia. Obtaining this authorization is in line with the new development plan unveiled last April and allows us to move with confidence towards the initiation of the SARA international study expected in the first semester of 2017.”
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.
The Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp gave their authorization regarding the initiation of the SARA-PK study to qualify pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). This study will be conducted during the second half of 2016 in two phases: the first phase will compare pharmacokinetics in elder and young volunteers after escalating single dose administrations of Sarconeos; the second phase will 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.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: “The authorization from Belgian health authorities to initiate the SARA-PK study is an important step in the development of the first treatment for sarcopenia. Obtaining this authorization is in line with the new development plan unveiled last April and allows us to move with confidence towards the initiation of the SARA international study expected in the first semester of 2017.”
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.