Soligenix surges ~250% after HyBryte shows compatibility with light device for blood cancer

Soligenix (NASDAQ:SNGX) reported data from a compatibility study of its photodynamic therapy HyBryte ointment to treat cutaneous T-cell lymphoma (CTCL) using the Daavlin Series 7 visible light device.

HyBryte (SGX301) is a photodynamic therapy which uses visible light in the red-yellow spectrum for activation. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions that is taken up by cancerous T-cells, and then activated by visible light about 24 hours later.

The aim of the trial was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte and extend the pharmacokinetic profile using a more sensitive hypericin test.

Soligenix said that besides meeting these goals, the efficacy shown substantiated the results of a phase 3 trial called FLASH.

The current trial enrolled 9 patients to receive 8 weeks of HyBryte therapy of their cancerous lesions. Evaluation was done at week 10.

The company added that in this study all patients had improvements in their cumulative CAILS (Composite Assessment of Index Lesion Severity) score

Average improvement was 36.4%, while ranging from 8% to 100%.

The company noted that data from individual lesions showed that 7 of the 27 index lesions had at least a 50% improvement in their CAILS score and 4 of the 27 index lesions were completely resolved.

Soligenix noted that certain measurements of systemic exposure and cardiac output, which led to extremely low and limited levels of systemic hypericin detected in the blood and no observable impact to normal sinus rhythm.

"Important corporate objectives for the study were to replicate results previously observed in the FLASH study, while using finished drug product manufactured by our proposed commercial contract manufacturer and activated using a commercially viable light device," said Soligenix's President and CEO Christopher Schaber.

SNGX +247.18% to $4.93 premarket