Biophytis Presents SARA-OBS study results at the Annual Conference of The Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD)
Paris (France), Cambridge (Massachusetts, United States), December 14th, 2020, 8:00 a.m. CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company developing therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces the results of the SARA-OBS observational study.
The results were presented in an e-poster at the 13th international conference on sarcopenia, cachexia and wasting disorders (SCWD) on Saturday December 12th, 2020.
The e-poster entitled “SARA-OBS study: natural progression of sarcopenia and sarcopenic obesity in older adults”, was presented by Dr Cendrine Tourette, Translational and Clinical Research Project Leader in Neuromuscular Diseases at Biophytis, in the Abstract session 9: Therapeutic development (clinical) + Therapeutic development (pre-clinical) on Saturday December 12, 2020 at 7:55 pm CET.
The SARA-OBS study showed a rapid deterioration of the mobility in participants as measured by two walking tests - the 400-meter walk test (400MWT) and the 6-minute walk test (6MWD). Of note, mobility disability is the primary endpoint of the on-going SARA-INT Phase 2b clinical trial.
These results from the SARA-OBS trial demonstrated that the very stringent inclusion criteria being used in the Phase 2b SARA-INT trial with Sarconeos (BIO101) has selected patients at confirmed higher risk of mobility disability. This rapid deterioration in the mobility criteria, as measured by the two walking tests mentioned above, allows the treatment effect of Sarconeos (BIO101) to be observed when compared to placebo in a smaller trial population.
This approach to patient selection is an industry first, as previous sarcopenia studies have recruited a broader patient population with differing levels of risk in relation to mobility disability.
Dr Samuel Agus, Chief Medical Officer of Biophytis, said “We are pleased to present the full analysis of the SARA-OBS trial at this year’s virtual SCWD. The SARA-OBS study was designed to characterize a population of sarcopenic patients to be included in the SARA-INT Phase 2b study and the data shows that we have recruited the right patient population, namely patients with severe sarcopenia that are at a high risk for mobility disability. Based on this data we expect the SARA-INT trial to show that Sarconeos (BIO101) delivers a larger treatment effect versus placebo. These data provide us with greater confidence that the SARA-INT study will deliver a positive outcome and further emphasizes the potential of Sarconeos (BIO101) as a treatment for neuromuscular diseases. The last patient out from the SARA-INT study is expected in the coming days.”
Biophytis also participated to the Symposium entitled “Update on clinical research on sarcopenia” which took place on Saturday December 12th, 2020 from 3:30 pm to 4:25 pm.
The symposium included:
- a presentation on the “Current status of clinical research targeting Sarcopenia” by Dr Roger Fielding, Director and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University.
- a presentation on the “SARA program: the use of BIO101, a MAS receptor agonist, for the treatment of sarcopenia” delivered by Dr Cendrine Tourette, Translational and Clinical Research Project Leader in Neuromuscular Diseases at Biophytis.
- a panel discussion chaired by Professor Bruno Vellas, Coordinator of the geriatrics center of Toulouse University Hospital and including:
- Dr Roger Fielding, Director and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University,
- Dr Waly Dioh, Chief Operating Officer at Biophytis, and
- Dr Sam Agus, Chief Medical Officer at Biophytis
The symposium was supported by an unrestricted educational grant from Biophytis.***
The SARA-OBS clinical study evaluated the mobility, strength and physical activity of 185 sarcopenic patients aged over 65 years recruited from a dozen clinical centers in the U.S., Belgium, France and Italy over a 6-month period. The study has been designed to characterize a population of sarcopenic patients to be included in the SARA-INT study Phase 2b. The recruitment was carried out following criteria defined by the US Foundation for the National Institutes of Health: Measurement of muscle mass by DEXA, and by a short physical performance battery (SPPB). The following parameters are measured in this study: 6-minute walk test (6MWD), 400 meters gait speed test (400MWT), stair climb power test, electronically recorded patient-reported outcomes (ePROs): SF-36 QOL questionnaire, measures of muscle strength (handgrip strength test) and muscle mass, plasmatic biomarkers.
Sarcopenia is an age-related degeneration of skeletal muscle, which is characterized by a loss of muscle mass, strength, function and mobility disability, and increased risk of adverse health events and potential death resulting from falls, fractures, and physical disability. There are currently no approved drug treatments for sarcopenia, which has become the focus of increased research aiming to improve diagnosis and treatment. Sarcopenia is highly prevalent in the elderly (over 65) with an estimated prevalence between six and 22 percent.
Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19.
Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial in the United States and Europe (SARA-INT). It is also being studied in a clinical two-part Phase 2/3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the US.
A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD).
The company is based in Paris, France, and Cambridge, Massachusetts. The company's common shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825). For more information visit www.biophytis.com