A phase 3 trial of Soligenix’s cutaneous T-cell lymphoma treatment has squeezed under the bar for statistical significance. The finding sent shares in the nanocap drug developer up almost 50% at points in premarket trading.
New Jersey-based Soligenix designed the trial to test SGX301, a synthetic form of hypericin. Soligenix moved the drug into phase 3 in the belief it is taken up by malignant T cells and, when activated by fluorescent light, inhibits their growth. A small phase 2 trial linked SGX301 to a statistically significant improvement, with the p-value coming in just below the bar at 0.04.
Now, Soligenix has delivered similar results in a larger, 169-subject phase 3 trial. The Composite Assessment of Index Lesion Scores of subjects who received SGX301 improved by more than those of their peers on placebo, resulting in the trial hitting its primary endpoint with a p-value of 0.04.
The primary endpoint assessed patients at eight weeks. Soligenix is continuing to track and treat patients out to 12 weeks in an open-label portion of the study. Data from that portion of the trial are scheduled for June, but Soligenix used its release to tease the performance it has seen so far, claiming its preliminary assessment suggests “a significantly more robust response rate.”
Soligenix’s stock popped on the back of the readout, putting it in a better position to add to the $7.6 million in cash it currently holds. However, with Soligenix in line to receive non-dilutive money, the biotech plans to hold off on a capital raise until after it gets a look at top-line results from a phase 3 trial in oral mucositis.
“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.
The ClinicalTrial.gov listing for Soligenix’s phase 3 oral mucositis trial puts the primary completion of the study at June of this year. That trial is assessing SGX301 as a treatment for oral mucositis in patients undergoing chemoradiation for the treatment of squamous cell carcinoma of the head and neck.
Mar 19, 2020