The Food and Drug Administration (FDA) has completed its review and given the go-ahead to Soligenix regarding its Investigational New Drug (NYSE:IND) application for OrbeShieldTM (oral BDP), which is used to prevent death associated with the gastrointestinal acute radiation syndrome (GI-ARS). GI-ARS occurs after toxic radiation exposure and involves several organ systems, which can result in death within five to 15 days.
To-date, there is no established treatment or preventive measure for the GI damage stemming from high-dose radiation exposure, though BDP has been marketed since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Soligenix recently received Orphan Drug Designation for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
Receiving FDA clearance of the IND allows Soligenix to launch its development program, which will include safety and efficacy evaluations conducted in appropriate preclinical models as well as a phase 1/2 pharmacokinetic (NYSE:PK)/pharmacodynamic (PD) study of OrbeShieldTM in healthy adolescents and young adults.
Soligenix will use the PK/PD data from the phase 1/2 study to inform dose extrapolation from the animal studies to the appropriate dose in humans.
"We are very excited to advance the development of OrbeShieldTM which we believe has the potential to be a safe and effective medical countermeasure in the event of a nuclear attack or radiation accident," Kevin Horgan, MD, senior vice president and chief medical officer of Soligenix stated in the press release. "We believe our proprietary two-tablet system has the pharmacological, clinical and manufacturing attributes necessary to potentially provide a substantial contribution to our national defense response systems so that we are optimally prepared in the event of a public health emergency such as nuclear accident or terrorist attack."
For more information visit soligenix.com
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