BioSig Technologies Inc (NASDAQ:BSGM) said Tuesday that a merimepodib drug development program to treat coronavirus (COVID-19) run by subsidiary ViralClear Pharmaceuticals is expanding.
In a statement, Biosig said the size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.
When the trial was first initiated, it was thought that COVID-19 patients with National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scores of 3 and 4 (ie hospitalized patients who require non-invasive ventilation and patients who require high flow oxygen devices and supplemental oxygen, respectively) would have similar outcomes in terms of their disease.
However, the company said that based on a review of blinded data from the ongoing trial, subjects with scores of 3 and 4 are showing distinct differences. All subjects who were admitted with a score of 4 have had an uneventful course of disease and were rapidly discharged from the hospital due to improvement in clinical condition. The subjects who were admitted with a score of 3 fared differently: one group of subjects improved and were discharged from the hospital and are doing well at long-term follow-up, while others have not improved.
Based on the above and the small numbers of subjects in each NIAID group, ViralClear has decided to increase the enrollment in the current study to 80 subjects, with a focus on subjects with an NIAID score of 3 at entry.
BioSig said the decision to increase the subject number in the trial was also based on advice from industry experts and discussions with government agencies and non-governmental organizations. Once additional subjects are enrolled and further clinical data is obtained, the team will discuss with the US Food and Drug Administration the appropriate size for a Phase 3 trial.
Two additional Principal Investigators
Two additional Principal Investigators were added to the ongoing Phase 2 trial to improve the enrollment rate, increasing the total number of locations to 10, the Westport, Connecticut-based company said.
ViralClear has contracted with a US-based contract manufacturing organization (CMO) to manufacture the registration stability batches required for the New Drug Application (NDA) of the merimepodib oral solutions (drug product) that will also serve as clinical trial supplies for the Phase 3 trial.
In July 2020, ViralClear previously announced an agreement with another US-based CMO, AMRI, to produce the registration stability batches of the merimepodib (active pharmaceutical ingredient).
Biosig said the merimepodib monotherapy trial to be conducted in the outpatient setting will be initiated after the completion of the current Phase 2 combination trial.
The Emergency Use Authorizations (EUAs) for remdesivir and convalescent plasma, as well as the increasing use of dexamethasone as a standard of care in hospitalized COVID-19 patients, has precluded an evaluation of merimepodib monotherapy in this setting (ie hospitalized patients), the company said.
Contact the author: [email protected]
Follow him on Twitter @PatrickMGraham