Soligenix, Inc. Common Stock (NASDAQ:SNGX) recently announced that its synthetic hypericin or SGX301 continues to yield positive findings in a Phase 3 FLASH study in which the drug is administered to patients who have cutaneous T-Cell lymphoma.
The company revealed in its latest update about the phase 3 FLASH study of SGX301 that almost half of all the patients in the trial continue to demonstrate statistically significant and sustained improvements. The researchers involved in the study observed that patients treated with SGX301 for 18 weeks continued to show improvements in their response rates.
The report also noted that SGX301 was well tolerated and maintains a strong safety profile. No systemic exposure was observed in 6 months during the optional final cycle of the clinical trial. According to the recent Solegenix report, the data observed from the phase 3 FLASH study aligns with the positive primary endpoint data from the SGX301 response during 18 weeks of treatment.
The data shows a 50% or more reduction in combined CAILS (Composite Assessment of Index Lesion Score) in patients. In comparison, roughly 40% of patients that completed 12 weeks of treatment with SGX301 achieved similar reductions.
“Along with SGX301’s rapid response time and safety profile, the patch and plaque data from the study are extremely compelling,” stated Solegenix MD, Brian Poligone.
SGX301 has so far demonstrated the potential to be better than other available options
Dr. Poligone also noted that existing CTCL treatments achieve less efficiency in treating plaques and deeper lesions compared to SGX301 so far. If it is approved, SGX301’s ability to target thicker plaques and patches in CTCL will make it a more appealing therapeutic option. Dr. Poligone also added that the consistent results that align with a recent study’s positive findings involving a CTCL variant called folliculotropic mycosis fungoides, which is difficult to treat.
Soligenix CEO Christopher J. Schaber stated that the results that have so far been observed continue to reinforce the belief that SGX301 is a potential game-changer for CTCL patients. If it is rolled out into the market, it will be a welcome relief, especially for CTCL patients with unmet medical needs.