Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercialising products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has awarded an Orphan Products Development grant to support the evaluation of HyBryteTM (synthetic hypericin) for expanded treatment in patients with early-stage CTCL. This will allow the company to determine whether A prestigious academic institution that was a leading enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early stage cutaneous T-cell lymphoma was awarded the grant, which will total $2.6 million over the course of four years (CTCL).
According to Christopher J. Schaber, President and Chief Executive Officer of Soligenix, Inc., “We are thrilled the FDA is supporting the HyBryteTM initiative and allowing patients a chance to receive the treatment in an open-label context.” “CTCL is a very challenging orphan illness to treat, and it continues to be an area of unmet medical need despite the availability of a very restricted number of therapeutic alternatives that are both safe and effective. This study will serve to embark on potential home-use of the therapy, augment the safety database, and provide further real-world evidence into the practical use of HyBryteTM once it is commercially available. The results of Phase 3 provide the basis for our upcoming marketing application, and this study will serve to provide further real-world evidence into the practical use of HyBryteTM once it is commercially available.
The clinical trial RW-HPN-MF-01, which is called “Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients,” is planned to be an open-label, multicenter clinical trial that will enrol approximately fifty patients at as many as six of the highest enrolling clinical centres that took part in the Phase 3 FLASH study. Patients have the ability to be treated for up to 12 months with a dosage schedule of twice per week (visible light activation to follow ointment application by 24–6 hours). The evaluation of the number of treatment successes will be the primary objective of the study. A treatment success is going to be defined as a reduction of at least fifty percent in the cumulative CAILS (Composite Assessment of Index Lesion Severity) score from the beginning of the treatment to its conclusion. The beginning of the study is scheduled to take place during the fourth quarter of 2022.