The US Food and Drug Administration (FDA) has granted “Fast Track” designation to Soligenix programme for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate paediatric Crohn’s disease.
Soligenix has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for paediatric Crohn’s Disease.
Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX203 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.
“There are no FDA approved corticosteroid therapies for the induction treatment of Crohn’s disease in the paediatric population,” stated Christopher J Schaber, president & chief executive officer of Soligenix. “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.”
Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease 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, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn's disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease.
Crohn's disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. However, approximately 30% of people with Crohn's disease develop symptoms before 20 years of age. Paediatric Crohn's disease is a subpopulation of approximately 80,000 patients 0-19 years of age in the United States. Crohn’s disease tends to be both severe and extensive in the pediatric population and a relatively high proportion (25-40%) of pediatric Crohn’s patients have involvement of their upper gastrointestinal tract.
SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide 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 (i.e., immediate and delayed release) of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon. The FDA has previously awarded SGX203 Orphan Drug Designation for the treatment of pediatric Crohn's disease.
Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics.