Soligenix, Inc. (Nasdaq: SNGX) traded about 13% higher intraday after announcing that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of its FLASH (Fluorescent Light Activated Synthetic Hypericin) trial (Cycle 3) continued to significantly improve responses and remained safe and well-tolerated over six months. The data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.
According to its release, SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients who elected to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients showing such a reduction after completing 12 weeks of treatment in Cycle 2 (p=0.046).
The company also pointed out that continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study revealed that 12 weeks of treatment (Cycle 2) with SGX301 is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of cutaneous T-cell lymphoma (CTCL) when compared to Cycle 1 placebo lesion responses. The company believes the data demonstrate the unique benefits of the more deeply penetrating visible light activation of hypericin.
Importantly, SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the bloodstream after targeted topical application to the lesions, as well as the use of visible light.
Rapid Response and Safety
The update also noted that along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling. The results compare favorably to current treatments for CTCL that are generally less effective against plaques and deeper lesions, similar to the problem observed in treating psoriasis.
Also, the ability of SGX301 to target both patches and thicker plaques in CTCL is an essential feature of the therapy and, if approved, can benefit patients, regardless of their presentation. Soligenix also noted that the Cycle 3 results are consistent with the positive findings highlighted in a recently reported case study of folliculotropic mycosis fungoides, a hard to treat variant of CTCL where lesions are associated with the hair follicles deep in the skin and more resistant to phototherapy.
From a market perspective, the updated results continue to strengthen the company's belief that SGX301 has the potential to be a valuable and life-changing therapy for patients suffering from CTCL, which is an orphan disease and area of unmet medical need. As the study nears its conclusion, the company is expected to assess commercialization and/or partnership of SGX301 while in parallel preparing for filing the New Drug Application with the FDA.
It's important to mention that despite the challenges imposed by the COVID-19 pandemic, 2020 continues to be a very impactful year for Soligenix. The company reached several clinical milestones and is positioned well to achieve more in the coming weeks and months.
It's most near-term potential catalyst may come from the announcement of top-line final results from its other pivotal Phase 3 study of SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer patients. Results from that trial are expected before the end of the year.
Read more about Soligenix at https://get.ceo3in60.com/soligenix-bio/
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