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Soligenix Phase 3 FLASH Trial Scores Big; Efficacy After 12 Weeks Of Treatment Demonstrates Robust Statistical Significance

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Soligenix Phase 3 FLASH Trial Scores Big; Efficacy After 12 Weeks Of Treatment Demonstrates Robust Statistical Significance

April 30
11:12 2020

Soligenix (NasdaqCM: SNGX), on Thursday, released its follow-on 12-week report for its SGX301 FLASH Trial. Results were impressive, and according to the company, the 12-week readout increased the response rate in patients with cutaneous t-cell lymphoma (CTCL) two and a half-fold. The takeaway from the release is that SGX301 demonstrates increased efficacy with continued treatment in patients with CTCL.

Highlighting the SGX301 update, Soligenix noted that:

  • SGX301 treatment response continues to demonstrate highly statistically significant improvement after 12 weeks of therapy

  • Response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold

  • Reinforces positive SGX301 primary endpoint treatment response demonstrating statistical significance after 6 weeks of therapy 

The company highlighted in more detail the positive readout from the trial.

Soligenix Fortifies SGX301 Phase 3 Trial Data

According to Soligenix, continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40%.

In March of this year, Soligenix announced positive top-line results when the study achieved statistical significance (p=0.04) in its primary endpoint over the first 6-week double-blind treatment cycle (referred to as Cycle 1) (available here). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo in Cycle 1. After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold. Treatment responses for each cycle were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive response was defined as an improvement of at least 50% in the Composite Assessment of Index Lesion Score (CAILS) for three index lesions evaluated in both Cycles 1 and 2. The data continues to indicate that SGX301 is safe and well-tolerated.

Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study, stated, “As anticipated, the data continues to become more compelling with extended SGX301 treatment.” She added, “This treatment response is comparable to other, less safe, treatment alternatives, showing a statistically significant response at just 6 weeks, which continues to significantly increase with more treatment. The response rate at 12 weeks is similar to other therapies, some of which patients must take for more than a year. In addition to the efficacy demonstrated, SGX301 remains well tolerated with a unique mechanism of action that is not associated with DNA damage like other currently available therapies. I look forward to working with Soligenix to move this important new therapy forward with US Food and Drug Administration (FDA) so that patients may access it as soon as possible.”

Additional commentary came from Ms. Susan Thornton, Chief Executive Officer of the Cutaneous Lymphoma Foundation, the largest patient advocacy organization for CTCL, when she said, “The availability of a safe, rapid-acting, treatment for CTCL is extremely important to patients.” She noted, “From the patient perspective, you want a treatment that is safe and effective with the least amount of side effects. Many of the therapies available today either don’t work for all patients, don’t work for long periods of time, can’t be used by some because of their concerning side effects, or are used off-label creating access issues. As the leader of the patient organization and a patient myself, I know first-hand the importance of developing more therapies and options to support people living with this rare cancer.”

SGX301 On Path To Become A Best-In-Class CTCL Drug Option

The news is a potentially significant win for Soligenix. To those that questioned the efficacy value at the 6 weeks readout are most likely silenced by the Thursday news. The comparison to the placebo at 0.0001 is a home run, and the increase of response rate to 40% will probably please study evaluators when the drug pushes toward a hopeful and eventual FDA approval. SGX301 has the potential to become the best-in-class and safest drug on the market to treat CTCL. The drug is safe, well-tolerated, and is being proven most effective in treating this disease.

Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix, said, “We are extremely pleased with the study results, which demonstrate successful continued treatment with SGX301 and reinforces its potential to be a valuable and life-changing new therapy for patients suffering from early-stage CTCL, which is an orphan disease and area of unmet medical need.”

Soligenix traded sharply higher on the news.

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