Soligenix (OTCQB:SNGX) says it has been granted a US patent for topically active steroids to treat inflammatory gastrointestinal disorders.
The biopharmaceutical company said the patent's claims cover the use of beclomethasone dipropionate (BDP) in oral forms, which act concurrently in both the upper and lower gastrointestinal tract.
The company's oral formulation of BDP, a topically active corticosteroid, is currently in development for pediatric Crohn's disease, acute radiation enteritis, and gastrointestinal Graft-versus-Host disease (GVHD).
"The granting of this patent marks a key addition to our intellectual property portfolio in the field of topically active steroids," said president and CEO of Soligenix, Christopher J. Schaber.
"It demonstrates the novelty and utility of our two-tablet system comprising an immediate release and a delayed release combination of oral BDP and underpins our approach to treating multiple inflammatory gastrointestinal disorders such as pediatric Crohn's disease."
In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, BDP also benefits from several orphan drug designations, the company noted.
Oral BDP is a potent, topically active corticosteroid that has a local effect on inflamed tissue. The drug has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma.
Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.
Earlier this month, the company said that it received the green light from the US FDA to start a clinical program testing SGX203 as a potential treatment for pediatric Crohn's disease.
The company had previously received orphan drug designation for this indication for SGX203, or the oral form of BDP, which provides for seven years of post-approval market exclusivity in the US.
The clearance of the investigational new drug application allows Soligenix to start a phase 1/2 study of the drug in healthy adolescents and young adults. The first trial is expected to be initiated in 2012.
Crohn's Disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. It can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine.
The disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. Around 30 per cent of people with Crohn's develop symptoms before 20 years of age.
Pediatric Crohn's is a subpopulation of approximately 80,000 patients from 0-19 years of age in the United States.
Soligenix develops products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents.
Its lead product, orBec, is a locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a life-threatening complication of hematopoietic cell transplantation.
Through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.