Soligenix Announces Partnership with Sterling Pharma Solutions

U.S. Expansion of Synthetic Hypericin Active Ingredient Manufacturing

PRINCETON, N.J., Oct. 3, 2024 /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 that it has established a partnership agreement with Sterling Pharma Solutions (Sterling) to optimize and implement a commercially viable, scalable production technology for synthetic hypericin.  Synthetic hypericin, the active ingredient in the topical drug product formulations HyBryte™ and SGX302 being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively, is a potent photosensitizer that is topically applied to skin lesions.  Soligenix and Sterling are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

"We look forward to working with Sterling as we expand our synthetic hypericin manufacturing capabilities with the ultimate goals of scaling up the process while further reducing our cost of goods," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "We look forward to building on our already strong relationship to advance our topical hypericin clinical programs, most notably, HyBryte™ for the treatment of early-stage CTCL, toward potential commercialization worldwide." 

"Sterling is pleased to be collaborating with Soligenix on this important program.  We believe that Sterling's expertise in active pharmaceutical ingredient manufacturing and testing will provide great value to the Soligenix program while we work towards a commercial supply agreement. We look forward to working with the Soligenix team to help advance this program through the upcoming HyBryte™ Phase 3 confirmatory clinical study," stated Adam Kujath, Site Head at Sterling Pharma Solutions' Germantown, MD facility.

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 safe, 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 U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

The 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 (Cycle 1), 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 the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p