NEW YORK, NY – (NewMediaWire) – November 30, 2021 – Proof of concept in the biopharmaceutical sector is a process. Efficacy tests are performed, results are recorded from each round of clinical trials, and formulation changes are made if necessary. Each iteration moves the treatment closer to an NDA filing, with an end goal of achieving FDA approval. The goal is to gather enough data during trials to make that happen. Sometimes, you get more than what you’re looking for. That’s what happened with Soligenix (NASDAQ: SNGX) during their clinical trials of SGX301 (HyBryte™), a treatment option for cutaneous T-cell lymphoma (CTCL). Their research into using visible fluorescent light to activate synthetic hypericin to treat CTCL plaques and lesions has uncovered a potential treatment option for psoriasis.
Proof of Concept for SGX302 Demonstrated in Pilot Study
Soligenix conducted a small Phase 1/2 pilot study in psoriasis patients with mild to moderate symptoms. The results provided positive proof of concept (PoC) and additional research will now be conducted on SGX302, using visible light activated synthetic hypericin.
This is good news for those suffering from psoriasis. According to Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, “Having reasonable treatment options for earlier mild to moderate stages of psoriasis that are safe and effective is vitally important, hence the potential role for SGX302.
“To date, there has not been a photodynamic therapy (PDT) similar to SGX302 to treat inflammatory conditions such as psoriasis,” Dr. Bhatia went on to say. “The unmet need for therapies outside of topical agents, biologic agents, and small molecules is moderate in today’s market given high copayments and insurance deductibles as well as decreasing access to dermatologists.”
Dr. Bhatia, who participated in the Phase 3 FLASH trial of SGX301 in CTCL, believes that the data from the Phase 1/2 trial of SGX302 is compelling enough to be explored further. Based on his observations, he feels that the potential impact on epidermal turnover and inflammation as seen in CTCL should apply to skin areas affected by psoriasis as well.
Psoriasis Treatment Market Expected to Top $40 Billion by 2027
According to Fortune Business Insights, the global treatment market for psoriasis is projected to be $40.58 billion by 2027. Last year, it was just north of $20 billion. The increased prevalence of the condition, coupled with a demand for safer and more effective treatments, is driving the market. It’s estimated that 125 million people worldwide have psoriasis.
Unlike CTCL, which is a rare disease, psoriasis is a common condition that affects roughly 2-3% of the population. It is a chronic, non-communicable, itchy, and often painful inflammatory skin condition for which there is no cure. Soligenix, with its ground-breaking research into visible light-activated synthetic hypericin, is hoping to offer some relief.
Soligenix CEO, Christopher Schaber, PhD, said it best, “Psoriasis is an incurable disease that affects 7.5 million people in the U.S. and between 60 and 125 million people worldwide. Given our promising results with synthetic hypericin to date, we are hopeful that SGX302 will have a role to play in helping patients living with this difficult to treat and chronic disease.”
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