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Thursday, 8 November 2012
Soligenix shares pop after pediatric Crohn's drug gets fast track designation from FDA
Soligenix (OTCQB:SNGX) shares surged Thursday as the company announced that its program for SGX203 as a treatment for mild-to-moderate pediatric Crohn's disease has received fast track designation from the US FDA.
Shares in the company were lately higher by 16 cents, or 36 per cent, to 60 cents late Thursday morning.
The development-stage biopharmaceutical company had previously received orphan drug designation for this indication of SGX203, or the oral form of beclomethasone 17,21-dipropionate (BDP).
Fast track designation, which is designed to expedite the review of new drugs, is reserved for a drug intended to treat a serious or life threatening condition, and that shows the potential to address an unmet medical need.
Soligenix will now be eligible to submit a new drug application for SGX203 on a rolling basis, permitting the FDA to review sections of the application prior to receiving the complete submission.
Under the fast track program, new drug applications are typically eligible for priority review, which implies a shorter review period of six months.
"There are no FDA approved corticosteroid therapies for the induction treatment of Crohn's disease in the pediatric population," said president and CEO, Christopher J. Schaber.
"The FDA's action in granting fast track designation is an indication of SGX203's potential to address this debilitating, unmet medical need. We look forward to working closely with the FDA to potentially expedite the development and NDA review process."
In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults.
The data from the study will help inform dose selection for phase 2/3 clinical trials that follow. The first trial is expected to be initiated this year.
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 swelling caused by the disease extends deep into the lining of the affected organ, and can induce pain and cause diarrhea. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease, the company noted.
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 roughly 80,000 patients from 0-19 years of age in the United States. The disease tends to be both severe and extensive in the pediatric population, and can also stunt growth, delay puberty, and weaken bones.
The company's drug, SGX203, contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon.
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.