Evgen Pharma PLC (LON:EVG) said there were no safety or data issues around its lead compound, which is being used to treat people in acute respiratory distress, including those with severe coronavirus.
The update follows a review by the data monitoring committee (DMC) of the first 60 people enrolled on the phase II/III STAR COVID trial co-sponsored by the University of Dundee and NHS Tayside and funded by the LifeArc charity.
The next steps could be pivotal for the study of Evgen’s SFX-01. The DMC will assess analyse statistical feedback from 100 patients, focusing on both safety and futility (the latter being a method of determining whether the experimental arm of the trial should continue).
To do this, the data must be unblinded; in layman’s terms, this means researchers will discover which patients received the company’s drug and which took a placebo with no therapeutic effect.
As part of the process, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.
Evgen said this may lead to adjustments to the design of the trial for the remaining patients.
Among the range of possible outcomes is a change in patient numbers, possibly early termination for either safety, or futility or, alternatively, strong efficacy.
The initial unblinded efficacy results are expected in the second quarter.
SFX-01 is the company’s lead compound that has potential applications in cancers, inflammation and acute respiratory distress syndrome (ARDS), including COVID ARDS.
It is derived from sulforaphane, a compound from nature that Evgen has converted into a fully synthetic, patented drug.