Bellerophon Therapeutics Inc. said its nitric oxide therapy received the orphan-drug designation in the U.S. to treat chronic lung disease.
The U.S. Food and Drug Administration's designation covers the medicine's use to treat idiopathic pulmonary fibrosis, or IPF — a chronic lung disease characterized by the thickening and scarring of air sacs in the lungs.
The Warren, N.J.-based healthcare equipment company is conducting a phase 2/3 study dubbed iNO-PF to investigate nitric oxide and its proprietary INOpulse system to treat patients with IPF and other pulmonary fibrotic diseases.
Pulsed nitric oxide, delivered via Bellerophon's patented INOpulse device, is the first therapy with the potential to improve a patient's physical activity levels, cardiac output and oxygen saturation, the company said in a Sept. 16 press release.
It is estimated that about 100,000 people in the U.S. are affected by IPF, which reduces their life expectancy by two to five years from diagnosis.
The FDA's orphan-drug program is meant for medicines that can treat diseases and disorders affecting less than 200,000 people in the U.S. annually. With the designation, Bellerophon Therapeutics qualifies for benefits including seven years of market exclusivity if the medication is approved, tax credits covering clinical trial costs, eligibility for orphan-drug grants and discounts on certain administration fees.
