Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company, Thursday announced partnership with Sterling Pharma Solutions to develop a commercially viable, scalable production technology for synthetic hypericin.
Synthetic hypericin is the active ingredient in HyBryte and SGX302, which are being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively.
Soligenix and Sterling are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials.
A Phase 3 confirmatory study of HyBryte dubbed FLASH2 in CTCL is expected to be initiated this year.
"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, 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."
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