PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.
"We continue to look to the future with our Specialized BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage cutaneous T-cell lymphoma (CTCL). In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after just 6 weeks of therapy. This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles at 12 weeks (Cycle 2) and 18 weeks (Cycle 3), reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. With the study now concluded, we will begin preparing our new drug application for submission to the FDA. We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year."
Dr. Schaber continued, "Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the novel CoVaccine HT™ adjuvant in-licensed from BTG Specialty Pharmaceuticals (a division of Boston Scientific Corporation). Our heat stable ricin vaccine, RiVax®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award. With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
- On October 22, 2020, the Company announced the continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing 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 demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results has revealed that 12 weeks of SGX301 treatment (Cycle 2) is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p