Innovation Pharmaceuticals is set to increase dosing frequency in Phase II clinical trial of a drug candidate, Brilacidin, for treating moderate-to-severe Covid-19 in hospitalised patients.
A defensin-mimetic, Brilacidin is being developed by the company under Fast Track designation from the US Food and Drug Administration (FDA).
The latest development comes after an independent Data Monitoring Committee (DMC) concluded the review of the scheduled interim safety data from the randomised, double-blind, placebo-controlled trial.
Recruitment was paused on reaching 25% enrolment (30 patients) and the DMC carried out a pre-specified unblinded safety data review and evaluation.
After reviewing the data, the DMC advised increasing the dosing regimen of Brilacidin from three days to five days, as intended per the protocol, which has been implemented by Innovation Pharma.
The company has initiated recruitment for the five-day treatment regimen while efficacy data was not reviewed by the committee and is blinded.
Innovation Pharmaceuticals CEO Leo Ehrlich said: “We are thrilled with the recommendation of the DMC pertaining to the safety profile of Brilacidin, a drug that has repeatedly been shown in lab studies by virology experts as a top candidate for fighting infectious and resilient coronaviruses, including SARS-CoV-2, the pathogen responsible for Covid-19.
“There is a sense of urgency to develop novel pan-coronavirus therapeutics for Covid-19, particularly given the growing spread of variants worldwide, including P1 and B.1.1.7, which appear to be contributing to cases of infection cropping up in patients who have already been vaccinated.”
The clinical rationale for expanding treatment duration is to offer an extended time of systemic Brilacidin exposure at a level that can robustly suppress SARS-CoV-2 virus replication and associated symptoms.
This could increase therapeutic benefits in hospitalised moderate to severe Covid-19 patients, the company noted.
A similar five-day dosing regimen is the recommended initial treatment time for Gilead Sciences’ Veklury (remdesivir), an FDA-approved antiviral Covid-19 drug.