Biophytis has a big to-do list including treatments for Duchenne muscular dystrophy (DMD), sarcopenia and more. Unfortunately, COVID-19 doesn’t care how urgent the need is.
The French biotech has had to limit data collection, delay studies and end patient enrollment early for certain studies, disruptions brought on by the pandemic that have impacted multiple pillars of the pipeline.
Sarconeos, Biophytis’ lead candidate, is under development for the treatment of multiple diseases, including sarcopenia, a disease in which patients suffer from a gradual loss of muscle mass. Biophytis said that only half of expected data were able to be compiled for a phase 2 trial of the therapy in this indication due to the pandemic. Only 106 patients performed the 400-meter walk test at the end of treatment, which was the study’s primary endpoint. The restriction represents a 55% loss of efficacy data.
Even with the reduction in data, Biophytis has collected enough to begin conversations with the FDA to prepare for a phase 2/3 trial, President and CEO Stanislas Veillet, Ph.D., said in an April 7 news release. If the FDA gives the all-clear, the company hopes to begin enrolling patients in the second half of this year.
Sarconeos also ran into trouble in a phase 2/3 study called COVA in patients with severe respiratory manifestations of COVID-19. The data monitoring committee cleared the study for the late-stage portion in September 2021 based on efficacy. But once Biophytis got started, hospitalizations plummeted and patient recruitment slowed to a halt in the first months of 2022. The company decided to terminate the trial enrollment early so that results could be ready in the third quarter.
The drop in infections was fueled by high vaccination and collective immunization rates, along with the lower severity of the omicron variant. To date, 237 patients have been randomized, with the total cohort estimated to be between 310 and 465 patients across 35 clinical centers.
This delay mirrors challenges seen by other biotechs trying to test therapeutics as omicron became the dominant strain. SAB Biotherapeutics and Synairgen both saw the National Institutes of Health shut down studies involving their therapeutic candidates in March as the omicron wave crested.
Lastly, due to COVID-19’s impact on operational capabilities, Biophytis’ pediatric DMD study has been pushed back to the end of 2022 or the beginning of 2023, “depending on the evolution of the pandemic.”
Amid all the changes, Biophytis is “still concentrating on the company’s key objective,” bringing products to market, according to Veillet. The clinical-stage biotech—based in both Paris and Cambridge, Massachusetts—develops therapeutics aimed to slow degenerative processes tied to aging, including severe respiratory failure among COVID-19 patients.
A new Biophytis program, driven by the one and only COVID-19, has also launched. At the end of 2021, the Brazilian health authority approved the use of Sarconeos in an expanded access program to treat hospitalized patients with severe COVID-19. A maximum of 80 patients mechanically ventilated in Brazil will receive the drug for up to 28 days.