Bellerophon Therapeutics, a clinical stage biotherapeutics company, has announced changes to its leadership team to align with the company's focus of progressing its nitric oxide therapy program for patients suffering from pulmonary hypertension (PH), using Bellerophon's proprietary INOpulse delivery system.
The company's new leadership team, effective immediately, consists of:
Jonathan Peacock, chairman and chief executive officer of Bellerophon Therapeutics, said, "The leadership team announced today brings decades of experience in Pulmonary Hypertension, clinical operations, electro mechanical device production and development, as well as extensive knowledge and success in navigating global regulatory processes. Additionally, we have substantially streamlined our internal cost structure and expect to complete the first of two phase III trials of INOpulse in Pulmonary Arterial Hypertension (PAH) with our existing cash resources. We look forward to recruiting our first patient in this trial before the end of 2015."
As noted in the company's second quarter press release, both the FDA and the EMA have accepted Bellerophon's phase III development plan and management expects a Special Protocol Assessment (SPA) to be issued by the FDA within the next few weeks. The company plans to conduct two confirmatory phase III clinical trials of INOpulse in PAH, enrolling the first patient in the first of these two trials later this year. The primary endpoint for each trial will be the Six Minute Walk Distance test, with Time to Clinical Worsening as a secondary endpoint.
The second indication for INOpulse is PH associated with chronic obstructive pulmonary disease (PH-COPD). Over the last year, testing conducted by Bellerophon has demonstrated, in an acute setting, the ability of pulsed nitric oxide to reduce PH for COPD patients and to improve blood volume in the blood vessels within the lung. In order to build on this data, the company plans to conduct further proof-of-concept work with COPD patients over the next 12 months to test the ability of INOpulse therapy to improve exercise capacity by reducing PH.
Bellerophon's clinical team also is planning to initiate early proof-of-concept work to treat PH associated with Pulmonary Fibrosis. As with COPD, this is an area of PH caused by constriction of the blood vessels for which no treatment currently exists. Other diseases for which patients suffer PH and for which INOpulse therapy may be useful include chronic thromboembolic pulmonary hypertension (CTEPH), a distinct pulmonary vascular disease caused by chronic obstruction of major pulmonary arteries; PH associated with sarcoidosis, a condition caused by the growth of tiny collections of inflammatory cells in different parts of the body, including the lungs; and, PH associated with pulmonary edema from high altitude sickness.