The trial was designed to test SGX301 which is a synthetic form of hypericin; the drug was moved into phase 3 in the belief that it is taken up by malignant T-cells and when activated by fluorescent light inhibits their growth.
A phase 2 trial linked the drug to statistically significant improvement, with the p-value coming in at 0.04. Now similar results have been achieved in a larger phase 3 trial; the composite assessment of index lesion scores of those receiving the drug improved by more than those on placebo resulting in the trial reaching the primary endpoint with a p-value of 0.04.
Primary endpoint was assessed at 8 weeks, the company is continuing to track and treat subjects up to 12 weeks in an open label portion of the study. Data from that portion of the trial is scheduled for June, but this release was used to talk about performance seen so far wherein the company claims the preliminary assessments suggest “a significantly more robust response rate.”
Stock in the company has increased putting it in a better position to add to the some $7.6 million in cash that it currently retains. To receive non-dilutive money the company plans to delay a capital raise until after getting a look at the top line results from a phase 3 trial on oral mucositis with the rimary completion listed as being June 2020; this trial is assessing SGX301 as a treatment for oral mucositis in patients undergoing chemoradiation for treatment of squamous cell carcinoma of the neck and head.
“This will afford us the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the new drug application submission to FDA,” Soligenix CEO Christopher Schaber said in a statement.
