Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that the United States (US) Patent Office has granted the patent entitled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis."  The newly issued patent claims therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and adds 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 was recently initiated in 2017.  

Soligenix has reported positive phase 2 results with SGX942 in the treatment of oral mucositis in head and neck cancer (HNC) patients.  SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their HNC. In addition to the oral mucositis findings, an increased incidence of "complete response" of tumor at both the one month and twelve month follow-up visits were observed with SGX942 treatment, as well as decreases in mortality and infection rate.  Results from the phase 2 clinical trial have been published.

The new US patent, number 9,850,270, issued on December 26, 2017, is a significant addition to the patent portfolio for dusquetide and would be expected to expire in 2034.

"Soligenix continues to pursue broad patent coverage for its dusquetide technology, first with composition of matter claims followed by therapeutic use claims in oral mucositis," stated Christopher J. Schaber, PhD, president and chief executive officer of Soligenix.  "Having successfully pursued composition of matter claims in jurisdictions worldwide, we continue to pursue therapeutic use claims like those issued in the US 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 IDR analogs."