IPF is a progressive, irreversible and fatal interstitial lung disease characterized by thickening and scarring of the air sacs in the lungs affecting approximately 100,000 people in the U.S. and reducing their life expectancy to between two and five years from diagnosis. IPF patients suffer from severe functional impairment that limits their ability to perform basic daily tasks, resulting in a significant deterioration in their quality of life. Pulsed nitric oxide, delivered via Bellerophon’s patented INOpulse® device and delivery algorithm, is the first therapy with the potential to improve a patient’s physical activity levels, cardiac output and oxygen saturation by treating both the ventilation perfusion mismatch driven by the fibrosis, as well as pulmonary hypertension, a common comorbidity in the IPF patient population.
Bellerophon is currently conducting a Phase 2/3 (iNO-PF) study of nitric oxide and its proprietary INOpulse system to treat patients with IPF, as well as other pulmonary fibrotic diseases.
“The receipt of orphan drug designation represents a significant milestone for our INOpulse clinical development program,” said
The mission of the FDA’s
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the
Fabian Tenenbaum, Chief Executive Officer
|At LifeSci Advisors:
Source: Bellerophon Therapeutics, Inc.