Shares of biotherapeutics company Bellerophon Therapeutics Inc BLPH 168.37% were more than doubling Tuesday following a positive clinical readout from the company.
Bellerophon’s Trial Results
Warren, New Jersey-based Bellerophon said top-line results from the PHPF-002 study showed statistically and clinically significant improvements in hemodynamic parameters.
The acute intra-patient, dose-escalating hemodynamics study is evaluating its INOpulse in pulmonary arterial hypertension associated with pulmonary fibrosis, or PH-PF.
The improvements seen were a 21% reduction in pulmonary vascular resistance on dose escalation from iNO30 to NO45 and a 12% reduction in mean pulmonary arterial pressure, Bellerophon said.
The company also said iNO was well-tolerated with no safety concerns across the dosages.
The INOpulse program is the company’s proprietary pulsatile nitric oxide delivery system. Bellerphon is developing multiple product candidate under its INOpulse program.
“The acute hemodynamic improvements observed on iNO, along with the increased benefit demonstrated on iNO45 versus iNO30, correlate with the chronic benefit of iNO recently reported in Phase 2 of the Company’s ongoing Phase 2/3 iNO-PF study,” according to the company.
Bellerophon Turns To Phase 3 Study
Bellerophon sees the benefits demonstrated in multiple Phase 2 studies as supporting INOpulse’s potential to become a transformative therapy for PH-PF patients.
“The hemodynamic dose response data generated in PHPF-002 validate the pulmonary vasodilatory capability of INOpulse, confirming the therapeutic benefit of iNO30 and supporting further benefit on iNO45,” CEO Fabian Tenenbaum said in a statement.
The company said it is now looking ahead to assess the benefit of INOpulse in its upcoming pivotal Phase 3 study.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.