Soligenix, Inc. (NASDAQ: SNGX) is engaged as a late-stage biopharmaceutical company that is focused on the research, development and commercialization of products to treat rare diseases. Shares of the biopharma company are skyrocketing 111% through early trading on Thursday, May 4, 2023. Over the past three months, Soligenix has seen average daily volume of 42,640 shares. However, volume of 27.86 million shares or dollar volume of around $89.43 million, has already exchanged hands through early trading.

Shares of Soligenix are soaring after the company announced positive results from a compatibility study (protocol HPN-CTCL-02) of HyBryte™ (synthetic hypericin sodium) for the treatment of cutaneous T-cell lymphoma (CTCL). The study involved using the Daavlin Series 7 visible light device, which recently received FDA 510(k) clearance. The open-label study enrolled nine patients for an eight-week HyBryte™ treatment, with treatment response assessed at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score.

The study aimed to confirm that any light device producing visible light with an appropriate and consistent wavelength (500 to 650 nm) was suitable for HyBryte™ use and to extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay. The efficacy demonstrated in the study strongly supports the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study. The treatment response data showed 22% improvement after eight weeks of twice-weekly HyBryte™ therapy, consistent with the FLASH trial’s results. All patients experienced improvements in their cumulative CAILS scores (average improvement of 36.4%, range 8 to 100%).

Results in individual lesions showed that 25.9% of the index lesions had at least a 50% improvement in their CAILS score, and 14.8% of the index lesions were completely resolved after only eight weeks of treatment. Systemic exposure and cardiac output measurements demonstrated extremely low and limited levels of systemic hypericin detected in the blood and no observable impact on normal sinus rhythm, reinforcing HyBryte™’s safety.

Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the compatibility study, expressed excitement about working with Soligenix and making HyBryte™ available to patients. He anticipates continuing collaboration with Soligenix to further advance the HyBryte™ program and provide patients with this much-needed treatment option.

“These results reinforce the positive HyBryte™ data from the FLASH study. 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,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We look forward to continuing to work with Dr. Poligone and all of our committed clinical investigators to make HyBryte™ available to this underserved orphan patient population.”

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