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  • Soligenix (SNGX) Stock Soars Following Promising Trial Results

    Soligenix (SNGX) Stock Soars Following Promising Trial Results

    Following the release of positive trial data, shares of Soligenix, Inc. (NASDAQ: SNGX) saw a significant increase in value. SNGX’s stock was up 95.20% at $2.44 as of the most recent trading. The spike comes after the company revealed that the major effectiveness goals of its Phase 2a proof-of-concept study for SGX945 (dusquetide) in treating Behçet’s disease were met.

    Phase 2a Research Shows Efficacy on Par with Authorized Therapy

    The Phase 3 study of apremilast (Otezla), which supports its marketing approval for oral ulcers in Behçet’s disease, was closely modeled by the Phase 2a open-label experiment. The results of SGX945 were compared to the apremilast and placebo groups of that Phase 3 trial.

    Over the course of four weeks, SGX945 showed improvements in oral pain and ulcer count that were equivalent to those seen with apremilast. Interestingly, effectiveness continued through Weeks 5–8, almost matching continuous apremilast therapy throughout the same time frame, even though SGX945 medication ended at Week 4.

    Sustained Benefits Beyond Treatment Period

    Using the same primary endpoint—area under the curve (AUC) for mean ulcer count over time—SGX945 achieved a 40% improvement versus placebo, compared to 37% for apremilast. At Week 8, four weeks post-treatment, SGX945 maintained a 32% improvement, while apremilast, administered through Week 12, recorded a 41% improvement.

    Seven of eight patients reported symptom relief, including shorter ulcer duration, fewer occurrences, and reduced pain. A skin ulcer in one patient, typically difficult to treat, resolved during the study. SGX945 was well tolerated, with no treatment-related adverse events reported.

    Future Development and Market Potential

    Soligenix plans to reformulate SGX945 for home-based administration via subcutaneous injection, potentially supporting chronic or maintenance use. SNGX is to progress the development of dusquetide for Behçet’s Disease and other inflammatory illnesses linked to the innate immune system.

    Behçet’s disease is a major unmet medical need, with an estimated 18,000 people in the United States, 50,000 in Europe, 350,000 in Turkey, and up to 1 million worldwide. SGX945 may become a competitive option to existing treatments given the effectiveness, longevity, and tolerability seen, especially for individuals with severe or chronic ulcers.

  • What Do The SNGX Stock Declines On In Premarket?

    As of today’s premarket session, shares of Soligenix Inc. (SNGX) have fallen by -9.16% to $1.19. Soligenix stock added 25.96% to finish the last trading session at $1.31. In the last five days, SNGX stock shares declined 13.93%, but over the last month, they gained 21.30%. Over the last three months, SNGX stock price has fallen by 17.09 percent, and this year so far it has fallen by 31.05 percent. In premarket trading, SNGX stock is falling as investors are seen to be taking profits off of gains made in yesterday’s trading.

    SNGX rose in regular session for what reason?

    As a biopharmaceutical company, Soligenix focuses on the development and marketing of products for the treatment of rare diseases where there is a medical need. The Specialized BioMarketing business segment of SNGX is developing and exploring the potential commercialization of HyBryte, which is a novel photodynamic therapy utilizing safe visible light to treat cutaneous T-cell lymphomas (CTCL). The Phase 3 study for this product candidate has been completed successfully, and SNGX is seeking approval to advance commercialization activities.

    Yesterday, PCG Digital published an interview with Dr. Ellen Kim, Lead Principal Investigator for Soligenix. At the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting, she presented key details of the Phase 3 FLASH study for Soligenix in CTCL that recently showed significant efficacy and safety data for HyBryte. After the meeting, Dr. Kim was interviewed concerning the HyBryte data and current CTCL treatment options.

    At the USCLC Annual Meeting scheduled for June 26, 2021, Dr. Kim presented critical details about efficacy and safety profile of Soligenix’s HyBryte, demonstrated in the FLASH study.

    • HyBryte was studied in detail at SNGX, which showed it to be safe and effective in the vast majority of CTCL patients.
    • As part of the study, SNGX presented a comparison between the study data and current treatment options.
    • SNGX’s FLASH trial has recruited 169 patients, making it the largest multicenter, randomized, double-blind, placebo-controlled study in CTCL to date.
    • SNGX developed HyBryte so that it would be a safer alternative to currently available therapies, which all have significant and sometimes fatal side effects.
    • There is no suitable front-line therapy at present, and the currently approved treatments only exist after previous treatments have failed.

    What it means for SNGX?

    In a landscape with many competitive players, Soligenix (SNGX) may have a greater opportunity in CTCL treatment, since HyBryte might represent the most efficacious treatment available that is also as safe as possible. To date, SNGX has found no evidence of any potential safety issues in that product due to its lack of systemic absorption, nonmutagenic compound, and carcinogenic light source.