PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a biopharmaceutical company, announced its plans to initiate a confirmatory Phase 3 study for its therapeutic candidate HyBryte™, aimed at treating cutaneous T-cell lymphoma (CTCL), following an agreement on study design with the European Medicines Agency (EMA).
The study, referred to as FLASH2, is set to begin patient enrollment by the end of 2024, with expectations to release top-line results in the latter half of 2026.
FLASH2 will be a placebo-controlled trial enrolling approximately 80 patients across the United States and Europe. It is designed to extend and replicate the results of the initial Phase 3 FLASH study, which showed a 49% treatment response rate (p
Unlike the first study, FLASH2 will implement a continuous 18-week treatment period without breaks, aiming to demonstrate an increased effect over a longer and more practical treatment course.
The trial will assess the safety and efficacy of HyBryte™, a synthetic form of hypericin, when applied topically to CTCL lesions and activated by visible light. The primary endpoint will measure the percentage of patients achieving a Partial or Complete Response, defined as a ≥50% reduction in the total modified composite assessment of index lesions severity (mCAILS) score for the indexed lesions after 18 weeks of treatment compared to baseline.
Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, emphasized the importance of long-term safety in CTCL treatments and highlighted the promising safety profile of HyBryte™ in clinical studies.
Christopher Schaber, PhD, President and CEO of Soligenix, also remarked on the urgent need for well-tolerated and safe treatments for CTCL, expressing confidence in the potential of HyBryte™ based on previous study results.
The study will be blinded and include an interim analysis by a Data Monitoring Committee when roughly 60% of subjects have completed the primary endpoint evaluation. This analysis may lead to adjustments in sample size or early trial termination for reasons such as futility or safety concerns.
HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the EMA. The Phase 3 FLASH study was partially funded by the National Cancer Institute and the FDA awarded a grant to support extended HyBryte™ treatment investigation.
This announcement is based on a press release statement from Soligenix, Inc.
InvestingPro Insights
As Soligenix, Inc. (NASDAQ:SNGX) gears up for its FLASH2 Phase 3 study for HyBryte™, the company's financial health and stock performance provide context for investors monitoring its progress. According to InvestingPro data, Soligenix holds a market capitalization of $5.68 million as of the last twelve months ending Q4 2023. This small-cap status reflects the high-risk, high-reward potential often associated with biopharmaceutical ventures.
Investors should note that the company's P/E ratio stands at -0.98, suggesting that the market has concerns about its profitability in the near term. This aligns with an InvestingPro Tip indicating that analysts do not expect Soligenix to be profitable this year.
The company's stock price has experienced significant volatility, with a 1-month price total return of -29.5% and a 1-year price total return of -73.27% as of the same period, which may be a point of consideration for those looking at the stability and long-term growth of their investments.
Moreover, Soligenix's gross profit margin is reported at -365.15%, a figure that underlines challenges in achieving profitability and underscores another InvestingPro Tip about the company's weak gross profit margins. Investors interested in a deeper dive into the financials and future outlook of Soligenix can find more InvestingPro Tips, with a total of 11 additional tips available at: https://www.investing.com/pro/SNGX.
For those considering an investment in Soligenix or seeking to better understand the company's financial standing as it advances its clinical trials, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription on InvestingPro, where you can access a comprehensive analysis of Soligenix's financial health and stock performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.