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June 29, 2022

Soligenix gets FDA clearance for Phase II psoriasis trial

The company plans to commence subject enrolment in the trial in the fourth quarter of this year.

Soligenix has received clearance for the Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for a Phase IIa clinical trial of SGX302 (synthetic hypericin) to treat mild-to-moderate psoriasis.

A new photodynamic therapy (PDT), the visible light-activated synthetic hypericin could potentially avert various long-lasting risks linked to other PDT treatments.

The company plans to commence subject enrolment in the trial in the fourth quarter of this year.

The randomised, double-blind, placebo-controlled trial will analyse the safety and efficacy of topical SGX302 for treating psoriasis.

It will enrol up to 32 subjects of the age 18 years or above with mild to moderate, stable psoriasis that covers 2 to 30% of their body. 

Trial subjects will be randomised into a 1:1 ratio to receive SGX302 or a placebo twice a week for up to 18 weeks.

Each treatment will comprise topical SGX302 application followed by visible light activation after nearly 24 hours.

The degree of lesion clearance and subject-reported quality of life indices will be the trial’s efficacy endpoints.

Soligenix president and CEO Christopher Schaber said: “We have clearly validated synthetic hypericin’s biologic activity with the Phase III FLASH study in this orphan disease, where we expect to file a New Drug Application (NDA) in the second half of 2022.

“Given our promising results with hypericin to date, including a small Phase I/II proof of concept clinical trial in mild-to-moderate psoriasis, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease.”

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