Soligenix jumps 6% on patent news for its oral mucositis drug, Dusquetide.

Shares of Soligenix, Inc. (Nasdaq: SNGX) jumped more than 6% on Monday after the company announced today that the Japanese Patent Office has granted the patent titled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis.” According to the release, this allowance builds on similar intellectual property in the United States (US), New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. Dusquetide previously demonstrated positive results in a Phase 2 oral mucositis clinical trial and a pivotal Phase 3 study is ongoing, with a positive interim analysis completed in August 2019 and final topline results expected in Q2 2020. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.

 

Based on the positive and previously published Phase 2 results, the pivotal Phase 3 clinical trial is a highly powered, double-blind, randomized, placebo-controlled, multinational trial. The study, called DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), is enrolling approximately 260 subjects with head and neck cancer (HNC) undergoing standard chemoradiation therapy (CRT) and who are therefore at high risk of developing severe oral mucositis. Enrollment is ongoing in the US and across Europe with enrollment completion expected in Q1 2020 and final topline primary endpoint results anticipated in Q2 2020.

 

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, commented on the patent by saying, “Soligenix continues to pursue broad patent coverage for its IDR technology, including dusquetide, first with composition of matter claims followed by therapeutic use claims in oral mucositis,” He added, “Having successfully pursued composition of matter claims in jurisdictions worldwide, we continue to pursue therapeutic use claims like those issued in the US previously and in Japan with this most recent patent. The therapeutic use claims are expected to be generally valid until 2034, which provides significant patent protection and life to dusquetide and our other IDRs. This allowance is timely as we continue to have discussions with potential strategic partners and pursue all options to advance our pipeline and plan for commercial activities.”

 

Soligenix is also nearing the release of its topline data for its CTCL drug, SGX301. Data from that trial is expected by the end of this quarter.