Soligenix (OTCQB:SNGX), a clinical stage bipharmaceutical company, said today it has enrolled and treated all the patients in its phase 1 study for SGX203 - one of its main product candidates and a potential treatment for pediatric Crohn's disease.
The company, which is focused on developing products to treat inflammatory diseases and biodefense threats, said the oral BDP - beclomethasone 17,21-dipropionate - treatment's development program has received fast track and orphan drug designations from the U.S. FDA.
The 24-person study, conducted in healthy males and females between the ages of 18-22, was done to further characterize the pharmacokinetic (NYSE:PK) and pharmacodynamic profile of the oral drug.
The company said that preliminary pharmacokinetic results, which will be used to refine the model, show that the pharmacokinetic profile in this population is consistent with the profile seen in previous studies in a broader population, supporting a twice-a-day dosing regimen. The drug was also found to be safe and well tolerated, Soligenix said.
"We have designed this program in collaboration with an expert in PK modeling and simulation, Jeffrey S. Barrett, PhD, FCP, from The Children's Hospital of Philadelphia," said senior VP and chief medical officer for Soligenix, Kevin J. Horgan, MD.
"The PK data generated from this study will be used to refine the PK model we have established with Dr. Barrett. The refined model will provide the justification for limited PK sampling in the subsequent Phase 2/3 pediatric clinical study and will help inform the dose selection for the Phase 3 component of the study."
Dr. Horgan added that the use of this data reflects the "state of the art" in prediatric drug development, by leveraging the maximum amount of information from the enrolled subjects.
Soligenix's drug main ingredient, BDP, is a topically active corticosteroid that has a local effect on inflamed tissue, and has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for treating allergic rhinitis and asthma. SGX203 is a two tablet delivery system of BDP, which is designed for the immediate and delayed release of the drug throughout the small bowel and colon.
Crohn's disease is an ongoing disorder that causes inflammation of the GI tract, and most commonly affects the lower part of the small intestine, causing frequent diarrhea and pain. Though it can appear at any age, it is most often diagnosed in adults in their 20s and 30s, according to the company's statement, but around 30 per cent of people with the disease develop symptons before they hit 20. Based on review of historic published studies and reports and an interpolation of data on the incidence of Pediatric Crohn's disease, it is estimated that Pediatric Crohn's is a subpopulation of approximately 80,000 patients in the US with a comparable number in Europe.
The news on Friday follows an announcement from Soligenix earlier this week, when it put to bed a $7.1 million public offering of its common stock and warrants, with a chunk of the funds hailing from a firm linked to billionaire life sciences investor Randal J. Kirk. The company issued 6.77 million shares of common stock and five-year warrants to purchase up to 5.08 million shares.
Soligenix said it would use the new funds raised to further develop its pipeline of drugs, as well as for general working capital. Its two lead product candidates are its oral BDP treatment for pediatric Crohn's disease, and a treatment for oral mucositis, for which the company plans to start a phase 2 clinical study in the second half of this year. Earlier this month, the company received fast track designation from U.S. regulatory authorities for the treatment for oral mucositis, which is a complication of radiation and/or chemo in head and neck cancer patients.
In its biodefense unit, Soligenix is working on its Thermovax vaccine thermostabilization technology. According to the company, for vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the use of ThermoVax, which has been tested in combination with the company's RiVax and VeloThrax vaccines, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.
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