Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercialising products to treat rare diseases, announced that the Chinese Patent Office intends to grant the patent entitled “Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.”
The newly issued patent claims composition of matter of dusquetide (research name: SGX94) and related analogs. Dusquetide recently demonstrated positive results in a phase 2 oral mucositis clinical trial. China now becomes the most recent jurisdiction to grant patent coverage over the composition of matter of dusquetide. Similar claims have been granted in the United States, Australia, Israel, Japan, Mexico, New Zealand, Republic of Korea, Russian Federation, Singapore, South Africa and Taiwan. Furthermore, Soligenix is expecting to be granted similar protections in other important jurisdictions, including Europe, in the very near term.
Soligenix recently reported positive phase 2 results with SGX942, its drug product containing dusquetide, in the treatment of oral mucositis in head and neck cancer patients. SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis by 50 per cent in all patients and by 67 per cent in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. In addition to the oral mucositis findings, an increased incidence of “complete response” of tumor at the one month follow-up visit was observed (47 per cent in placebo versus 63 per cent in SGX942 at 1.5 mg/kg). Decreases in infection rate were also observed with SGX942 treatment.
The new patents correspond to US patent 8,124,721, granted on February 28, 2012, that primarily included composition of matter claims and therapeutic use claims in infectious disease for dusquetide.
“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. “Most recently, we were granted a composition of matter patent in China, which is of significant importance to us, as well as to SciClone Pharmaceuticals, Inc., our commercial partner for the Greater China market. The composition of matter patents are generally valid until 2028. The therapeutic use claims in oral mucositis will follow in the same jurisdictions, providing extended intellectual property coverage.”
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40 per cent of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy (>80 per cent incidence of severe mucositis) and is common (40-100 per cent incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.
Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.
SGX942 is an innate defense regulator (IDR), which contains a new class of short, synthetic peptide, having the chemical name dusquetide. It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis and other bacterial infections.
SGX942 has demonstrated safety in a phase 1 clinical study in 84 healthy human volunteers. Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50 per cent overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients exposed to the most aggressive concomitant chemotherapy, the reduction in the duration of severe oral mucositis was even more significant at 67 per cent when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol. Additional observations included an improved tumor response to CRT therapy at the one month follow up visit (47 per cent in placebo versus 63 per cent in SGX942 at 1.5 mg/kg), as well as decreases in infection rate.
Dusquetide and related analogs have a strong intellectual property position, including composition of matter. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.
SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients. Fast track designation is designed to facilitate the development and expedite the review of new drugs.