Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma
Results Confirm and Extend Response Results from Phase 3 FLASH Study
PRINCETON, N.J., May 4, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group.
The purpose of the study 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 recently developed, more sensitive hypericin assay. In addition to meeting these objectives, the efficacy demonstrated strongly substantiates the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study. The treatment response data of 22% following 8 weeks of twice weekly HyBryte™ therapy recapitulates the results of the FLASH trial, despite the fact that patients in the current study were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative CAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their CAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and cardiac output, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 µg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of HyBryte™.
"We were excited for the opportunity to work with Soligenix and make HyBryte™ available to our patients," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the compatibility study and Leading Enrolling Investigator in the FLASH study. "Since the completion of the Phase 3 FLASH study, I have had a number of patients asking about possible access to this promising therapy. Fortunately, we were chosen to conduct this study and the patients' enthusiasm for the product was evident by their willingness to participate in the trial, allowing for its rapid completion. I look forward to continuing to work with Soligenix to further advance the HyBryte™ program so my patients can have this much needed treatment option available to them."
"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."
About HyBryte™
HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).
The recently published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in
