Biophytis has submitted a Clinical Trials Authorisation (CTA) application to the European Medicines Agency (EMA) to initiate a Phase III trial in sarcopenia. The France-based biotech expects a response from the European regulatory authorities in the next quarter, which would allow Biophytis to start the clinical trial in Belgium in Q4 2023.
The Phase III trial will evaluate the safety and efficacy of Sarconeos (BIO101) in patients with sarcopenia who are at risk of mobility disability. Sarcopenia is a geriatric condition characterised by a gradual loss of muscle mass that affects 10%-16% of the elderly globally.
The biotech aims to enrol approximately 900 patients who are over the age of 65 and have severe sarcopenia with low walking speed and low grip strength. Patients will be treated with either placebo or 350mg of Sarconeos twice daily (BID) for a minimum of 12 months and a maximum of 36 months. Sarconeos is a non-peptide agonist of the Mas receptor. By activating the Mas receptor, the drug promotes protein synthesis and helps to increase muscle mass.
The primary endpoint of the trial will assess the risk of Major Mobility Disability (MMD), which is measured by the ability to walk 400m in less than 15 minutes. The trial’s secondary endpoints will assess the walking speed, which is measured by Short Physical Performance Battery (SPPB) test and handgrip strength (HGS). Patients will also complete a questionnaire that is developed specifically for sarcopenia to measure patient-reported quality of life.
In the meantime, Biophytis is preparing clinical trial documents that will be submitted to the FDA to initiate a Phase III sarcopenia trial in the US.
Phase IIb trial results
The submission for the Phase III trial comes after encouraging results from a Phase IIb study. In 2021, Biophytis announced the full results of the trial. 196 patients with sarcopenia at risk of mobility disability across the US and Belgium completed the study.
The dataset showed that the 350mg BID dose of Sarconeos demonstrated a clinically meaningful improvement in the 400m walk test, which was the primary endpoint of the trial, after six months of treatment. The drug showed a good safety profile at the doses of 175mg BID and 350mg BID with no serious adverse events related to the product.
Sarconeos in Covid-19
Earlier this month, Biophytis requested a pre-submission meeting with the EMA to discuss the conditional Marketing Authorisation (cMA) in Europe for Sarconeos in the treatment of a severe form of Covid-19. Later in this quarter, Biophytis will file a request for a pre-submission meeting with the FDA for an Emergency Use Authorisation (EUA) application.
As the Covid-19 pandemic shifts to an endemic, global organisations, such as World Health Organization (WHO), are announcing the end of the public health emergency (PHE). In the US, the end of a PHE was announced by President Joe Biden in January and officially ended last week. This move raised questions if Covid-19 planned clinical trials are at risk.