Bellerophon, FDA Agree on Design of Phase 3 INOPulse Clinical Trial

Bellerophon, FDA Agree on Design of Phase 3 INOPulse Clinical Trial
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Bellerophon Therapeutics has reached an agreement with the U.S. Food and Drug Administration (FDA) setting the design of an upcoming, pivotal Phase 3 clinical trial testing INOpulse, an investigational therapy, in people with pulmonary fibrosis (PF) who are at risk of pulmonary hypertension (PH).

PH-PF is characterized by a narrowing of the pulmonary arteries, the blood vessels that carry blood from the heart to the lungs. This raises the pressure within these arteries, which ultimately results in a decrease in cardiac output, or the amount of blood the heart is able to pump.

INOpulse is a device that delivers inhaled nitric oxide (iNO), which acts as a vasodilator — meaning it causes blood vessels to widen, reducing blood pressure.

This investigational treatment was previously tested in the Phase 2/3 iNO-PF clinical trial (NCT03267108). That trial assessed the effects of different dosages of INOpulse in three groups of people diagnosed with PF and at risk of developing PH.

Group 2 in that trial enrolled 44 participants who were randomly selected to receive 45 mcg/kg ideal body weight/per hour (mcg/kg IBW/hr) of INOpulse or a placebo for four months.

The results showed that patients treated with INOpulse had a significant increase in moderate-to-vigorous physical activity (MVPA), by 14 minutes a day. That corresponded to an approximately 20% improvement compared with the placebo group. MVPA is a parameter that include various tasks such as walking, climbing stairs, and doing yard work.

Significant improvements also were seen in self-reported quality of life and shortness of breath, as assessed through validated questionnaires.

Now, in consultation with the FDA, Bellerophon has finalized key elements of its upcoming Phase 3 clinical trial — including defining the population of people with PF who are at risk of PH. As in the previous trial, MVPA will be used as the primary endpoint, and 45 mcg/kg IBW/hr will be used as the therapeutic dose.

“We are very pleased with the alignment reached with the FDA on the design of our pivotal Phase 3 trial, which allows us to move confidently towards the initiation of this important study,” Fabian Tenenbaum, the CEO of Bellerophon, said in a press release.

“There is a pressing need to develop a safe and effective treatment for patients with PH-PF,” Tenenbaum added. “INOpulse, with its targeted pulmonary vasodilation, would potentially become the first therapy to treat a broad PH-PF population that includes patients at low, intermediate and high risk of pulmonary hypertension. We look forward to initiating our pivotal Phase 3 study in PH-PF shortly.”

Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
Total Posts: 329
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
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