Soligenix Announces Positive Top-line Results For Its Pivotal Phase 3 FLASH Trial Evaluating SGX301 In Treatment Of Cutaneous T-Cell Lymphoma

PRINCETON, N.J., March 19, 2020
Soligenix, Inc. SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.   

"This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study. "The treatment showed a statistically significant improvement after just 6 weeks of treatment. This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment. In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."

"On behalf of everyone at Soligenix, I would like to extend my sincere appreciation to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are extremely pleased with the results, which demonstrate successful treatment with SGX301 and reinforces its potential to be an important new treatment for early stage CTCL. We will now look to move as quickly as possible to complete a full analysis of the data for publication, as well as begin preparations for a robust discussion with the FDA regarding this important dataset."

Dr. Schaber continued, "With approximately $7.6M in cash, not including the anticipated sale of our New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of approximately $1.0M or our non-dilutive government funding, we will evaluate the potential need for a larger capital raise only after top-line results from our Phase 3 study in oral mucositis. This will afford us the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA. These results support our long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

Conference Call Thursday, March 19 at 8:30 AM Eastern Time

The Company will share trial results on Thursday, March 19, 2020 during an investor conference call. Investors may submit questions electronically at: ir@soligenix.com at least 15 minutes prior to the scheduled start of the call.

U.S. toll free:    1-866-652-5200
International:  1-412-317-6060
Please request to be entered into the Soligenix call.

A transcript of the conference call will be archived for 30 days following the event.

The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles, each of 8 weeks duration. 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, 116 subjects received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 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). SGX301 treatment in the first cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment. Of note, preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Further independent review of lesion photographs may be conducted to provide for a more uniform confirmation of response. Results from Cycle 2 are expected to be announced in June 2020.

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