Soligenix (OTCQB:SNGX), a clinical stage biopharmaceutical company, has received orphan drug designation for its active ingredient SGX94 for the treatment of acute radiation syndrome (ARS), as it continues to advance its biodefense pipeline.
The company is advancing numerous drug candidates, with a portfolio of multiple programs targeting indications that each have at least $200 million plus of worldwide market potential. It ended the second quarter with cash and equivalents of $8.1 million, more than double the position at the end of calendar 2012, as a result of proceeds from its $7.1 million public offering with a firm linked to renowned billionaire life sciences investor Randal J Kirk.
Soligenix's shares have more than tripled in value since the beginning of the year, as no stone has been left unturned in the development of the company's promising therapeutics and biodefense pipeline.
"The FDA's decision to grant SGX94 orphan drug designation signifies an important step for Soligenix as we continue to expand our biodefense pipeline and the many potential applications of our novel IDR technology," said president and CEO Christopher J. Schaber in a statement released Monday.
SGX94 is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates resolution of tissue damage following exposure to a number of agents including bacterial pathogens, trauma, radiation and/or chemotherapy, according to the New Jersey-based company's release.
The class of drugs have no direct antibiotic activity but modulate host responses, increasing survival after infections. ARS occurs after toxic radiation exposure and involves several organ systems, notably the skin, the bone marrow and the gastrointestinal (GI) tract.
The active ingredient SGX94 is also in Soligenix's lead drug candidate, SGX942, a drug designed to treat oral mucositis, a debilitating side effect of cancer therapies such as radiation or chemo, in head and neck cancer patients. The drug is coming upon its phase II trial, expected to start by the end of the year.
An orphan drug designation from the U.S. FDA is intended to assist companies to develop safe and effective therapies to treat rare diseases and disorders. In addition to providing a seven year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits for SGX94, the company said Monday. This includes government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.
In a phase one study, SGX94 showed safety in healthy human volunteers and efficacy in numerous animal disease models, saidSoligenix, including mucositis, colitis, skin infection and other bacterial infections. About $40 million has been put towards developing the drug to date, inclusive of government grants.
"SGX94's activity in preclinical models has demonstrated the potential to mitigate damage to the skin and gastrointestinal tract, as well as enabling clearance of infection as a result of damage to the hematopoietic system, all of which occur with varying severity in ARS," said Dr. Schaber, adding that the marketing exclusivity from the new orphan status will add significantly to the existing patent estate for SGX94.
Aside from its biodefense unit, Soligenix is also developing a host of biotherapeutics, such as SGX942 for which SGX94 is the active ingredient. Its pediatric Crohn's candidate -- the two-tablet proprietary formulation of oral BDP (beclomethasone 17, 21-dipropionate) -- is also an area of significant market potential, as there are some 160,000 children and adolescents with Crohn’s worldwide.
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