- The stock price of Biophytis SA (Nasdaq: BPTS) increased by over 20% pre-market. This is why it happened.
The stock price of Biophytis SA (Nasdaq: BPTS) – a clinical-stage biotechnology company focused on 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 – increased by over 20% pre-market. Investors are responding positively to the company announcing the top-line results of the SARA-INT phase 2 clinical study with Sarconeos (BIO101) in Sarcopenia:
The effect of two doses of Sarconeos (BIO101), 175 mg bid and 350 mg bid, have been compared to placebo on gait speed as measured by the 400-Meter Walk Test (400 MWT), the primary end-point of the study, in the Full Analysis Dataset (FAS) and in the Per-Protocol population (PP, subset of participants that complied to the clinical protocol).
Sarconeos (BIO101) at the highest dose of 350 mg bid showed a clinically meaningful improvement compared to placebo in gait speed as measured in the 400MWT after 6 months of treatment, of 0.09 m/s in the FAS population and 0.10 m/s in the PP population (treatment effect significant, p < 0.01).
The effect of Sarconeos (BIO101) at 350 mg bid is close to the Minimal Clinically Important Difference (MCID) in sarcopenia (0.1 m/s), associated with a reduction in mobility disability and mortality in the elderly. Sarconeos (BIO101) at the lowest dose of 175 mg bid did not show a clinically meaningful difference compared to placebo in gait speed after 6 months of treatment neither in the FAS population (0.04 m/s) nor in the PP population.
No treatment effect was detected on the handgrip strength test and on the PF10 sub-score of the SF-36 PRO on mobility disability, key secondary endpoints of the study. A full report of the results, including analysis of other secondary end-points and biomarkers and analysis in sub-populations, will be presented during a seminar at the International Congress on Frailty and Sarcopenia Research (ICFSR) virtually from September 29 to October 2, 2021.
Sarconeos (BIO101) showed a very good safety profile after up to 9 months of dosing with no significant difference between treatments arms (175 mg bid or 350 mg bid) and placebo for Adverse Events, Serious Adverse Events, safety laboratory parameters, and vital signs.
Adverse Events percentages – were 36%, 37%, and 27% of the total Adverse Events for the placebo, 175 mg bid, 350 mg bid treatments respectively. Serious Adverse Events percentages – were 45%, 42% and 12% for placebo, 175 mg bid, 350 mg bid respectively. None of the Serious Adverse Events were related to the product.
Impact of the COVID-19 pandemic
The COVID-19 pandemic and the related restrictions had a significant impact on the conduct of the study, mostly on the quality of the data and the power of the study, as participants were not allowed to perform their on-site visits from March 2020 until more favorable sanitary conditions were observed locally. And 138 participants (59%) were still active in the study when COVID-19-related restrictions occurred. A total of 99 participants (43%) were not allowed to perform any physical assessment on-site while on treatment, despite the extension of the treatment period from 6 to 9 months. The treatment effects on the primary endpoint have been detected despite the negative impact of the COVID-19 pandemic.
The SARA-INT protocol
The aim of the SARA-INT study was to evaluate the safety and efficacy of Sarconeos (BIO101) for the treatment of age-related sarcopenia, leading to muscle atrophy and mobility disability. And 233 participants enrolled in 22 clinical centers in the USA and in Belgium were randomized in 3 treatment arms (175 mg bid, 350 mg bid versus placebo) and followed-up up to 6 months, adjusted to 9 months during COVID-19 pandemic.
Participants have been included in the study mainly based on age (>65 years old), low Appendicular Lean Mass (ALM) adjusted by Body-Mass Index (BMI) combined with reduced mobility assessed by the Short Physical Performance Battery index (SPPB ≤ 8). And efficacy was evaluated based on the gait speed from the 400-Meter Walk Test (400MWT) as the primary endpoint, in the Full Analysis Set population (FAS, all randomized participants ie 233 participants) and in the Per-Protocol population (PP, subset of participants that complied to the clinical protocol ie 152 participants). Handgrip strength and Patient-Reported Outcome (PRO) of mobility capacity as measured with the SF-36 questionnaire are key secondary endpoints.
“The SARA-INT results are encouraging based on the 400MWT gait speed improvement at certain doses, a critical assessment for seniors at risk of mobility disability.”
— Roger A. Fielding, PhD, who heads of the Nutrition, Exercise Physiology & Sarcopenia team at Tufts University in Boston and Principal Investigator of SARA-INT trial
“The results of Sarconeos (BIO101) on the 400MWT as the primary endpoint are promising since no other alternative treatment exists as of today. This paves the route towards an upcoming confirmatory phase 3 study in sarcopenia and further continue the development of Sarconeos (BIO101) in this indication.”
— Jean Mariani, MD, PhD, Professor of Neurosciences and Biology of Aging at Sorbonne University, Chief Medical Officer of Biophytis
“Despites COVID-19 pandemic, the SARA team has been able to demonstrate the potential of Sarconeos (BIO101) in sarcopenia. This is a key milestone for the company after 15 years of research and development together with Sorbonne University. We are now committed to progress Sarconeos (BIO101) into phase 3 either alone or through partnerships with pharmaceutical companies.”
— Stanislas Veillet, CEO of Biophytis