Development-stage biopharmaceutical company Soligenix(OTCQB:SNGX)Thursday said that it has regained the North American and European commercial rights to its oral treatment for inflammatory gastrointestinal disorders.
The company's oral formulation of beclomethasone dipropionate (BDP), a topically active corticosteroid, is currently in development for pediatric Crohn's disease, acute radiation enteritis, and gastrointestinal Graft-versus-Host disease (GVHD).
Through an amendment of its collaborative agreement with Sigma-Tau Pharmaceuticals, Soligenix said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products “with other parties without limitation”.
Oral BDP is a potent, topically active corticosteroid that has a local effect on inflamed tissue. The drug has been marketed in the U.S. 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.
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.
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 biopharmaceutical company also acquired SGX94 - a drug technology that regulates the immune system.
The innate defense regulator (IDR) regulates the immune system to reduce inflammation, eliminate infection, and improve tissue healing by binding to the regulatory protein p62.
Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division.
The company has acquired all rights to the technology as part of the deal, including composition of matter patents, and preclinical and phase 1 clinical study data.
SGX94, which Soligenix says is "highly synergistic" with its existing development pipeline, is poised to enter phase 2 clinical testing in humans.
Meanwhile, 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.
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