September 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff
HAMPTON, N.J. – Bellerophon Therapeutics is under new management and has announced a reduction of costs as it prepares to guide its proprietary delivery system through late stage clinical trials.
When announcing the new leadership team this morning, the company did not specify the reasons behind the shakeup or when the shakeup actually occurred.
The company said it had realigned its management team effective immediately to “align with the company’s focus of progressing its nitric oxide therapy program for patients suffering from pulmonary hypertension.” The company began hiring its new leadership team in 2014 when they tapped Jonathan Peacock as the new chairman of the board and chief executive officer. Over the last year, the leadership team has undergone a facelift. The new leadership team includes a new principal financial officer, a new head of device engineering, a new head of clinical operations, a new chief regulatory & safety officer and a new medical officer.
• David Abrams, principal financial officer
• Martin Dekker, head of device engineering and supply
• Amy Edmonds, head of clinical operations and administration
• Peter Fernandes, chief regulatory and safety officer
• Deborah A. Quinn, M.D., chief medical officer
“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,” Peacock said in a statement.
In addition to the new lineup of executives at Bellerophon, Peacock said the company has “substantially streamlined our internal cost structure.” In his statement, Peacock hinted the reasoning behind the adoption of more stringent financial controls was to keep costs within the company’s current cash resources as it heads into Phase III trials for its INOPulse delivery system for Pulmonary Arterial Hypertension (PAH). In June the company reported it had $54.7 million in available resources, which it expected to be sufficient funds to cover the costs of the two Phase III trials. Peacock said the company plans to recruit its first patients for the trials by the end of 2015 and be complete in the first half of 2018. The primary endpoint for each trial will be the six minute walk distance test, with time to clinical worsening as a secondary endpoint.
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Bellerophon‘s Phase III development plan and management expects a Special Protocol Assessment to be issued by the FDA within the next few weeks.
The second indication for INOpulse is PH associated with Chronic Obstructive Pulmonary Disease (PH-COPD), the company said. During earlier trials, Bellerophon said it demonstrated 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.
Additional uses for INOpulse therapy includes 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, the company said.
Bellerophon’s closed at $3.68per share on Monday.
