BLPH : Bellerophon Therapeutics Stock Analysis and Research Report

2017-10-19 - by Asif, Contributing Analyst

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Bellerophon Therapeutics is a clinical-stage therapeutics company focused on developing innovative products at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. Bellerophon's focus is the continued development of its nitric oxide therapy for patients with pulmonary hypertension, or PH, using its proprietary delivery system, INOpulse, with pulmonary arterial hypertension, or PAH, representing the lead indication. Its INOpulse platform is based on its proprietary pulsatile nitric oxide delivery device.

In February 2016, Bellerophon announced positive data from the final analysis of its Phase 2 long-term extension clinical trial of INOpulse for PAH, which was Part 2 of its Phase 2 clinical trial of INOpulse for PAH. The data indicates a sustainability of benefit to PAH patients who received INOpulse therapy at the 75 mcg/kg of ideal body weight/hour dose for an average of greater than 12 hours per day and were on long-term oxygen therapy, or LTOT. After reaching agreement with the U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, on its Phase 3 protocol, the company is moving forward with Phase 3 development. In September 2015, the FDA issued a Special Protocol Assessment, or SPA, for its Phase 3 PAH program for INOpulse, which will include two confirmatory clinical trials. The first of the two Phase 3 trials, or INOvation-1, has been initiated. During January 2017, Bellerophon received confirmation from the FDA of its acceptance of all of its proposed modifications to its Phase 3 program. Under the newly modified Phase 3 program, the ongoing INOvation-1 study, and a second confirmatory randomized withdrawal study with approximately 40 patients who will be crossing over from the INOvation-1 study, can serve as the two adequate and well-controlled studies to support a NDA filing for INOpulse in PAH subjects on LTOT. Both studies include an interim analysis approximately half-way through each study to assess for efficacy and futility. The interim analysis for the INOvation-1 study also includes a potential sample size reassessment.

Bellerophon completed a randomized, placebo-controlled, double-blind, dose-confirmation Phase 2 clinical trial of INOpulse for PH-COPD in July 2014. Bellerophon received results from this trial, and have initiated further Phase 2 testing to demonstrate the potential benefit on exercise capacity. In September 2015, an oral presentation of late-breaking data from a clinical trial sponsored by it was presented at the European Respiratory Society International Congress 2015 in Amsterdam. The data showed that INOpulse improved vasodilation in patients with PH-COPD. In July 2016, the results were published in the International Journal of COPD in an article titled "Pulmonary vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension." During May 2017, the company shared preliminary results of an ongoing Phase 2 PH-COPD study (n=10) designed to evaluate the acute effects of pulsed iNO on vasodilation as well as the chronic effect on hemodynamics and exercise tolerance. The interim data results from the first four patients showed a significant association between ventilation and vasodilation on acute treatment with iNO, suggesting that regions with better ventilation experience greater vasodilation. In addition, a meaningful reduction in sPAP (average 17.4%) was seen on all patients with chronic treatment of iNO.

Bellerophon has begun its clinical program in interstitial lung disease, based on feedback from the medical community and the large unmet medical need. During May 2017, Bellerophon announced completion of its Phase 2 study using INOpulse therapy to treat PH associated with idiopathic pulmonary fibrosis, or PH-IPF. The clinical data showed that INOpulse was associated with clinically meaningful improvements in hemodynamics and exercise capacity in difficult-to-treat PH-IPF patients. The PH-IPF study was a proof of concept study (n=4) designed to evaluate the ability of pulsed inhaled nitric oxide (iNO) to provide selective vasodilation as well as to assess the potential for improvement in hemodynamics and exercise capacity in PH-IPF patients. The study met its primary endpoint showing an average of 15.3% increase in blood vessel volume (p<0.001) during acute inhalation of iNO as well as showing a significant association between ventilation and vasodilation, demonstrating the ability of INOpulse to provide selective vasodilation to the better ventilated areas of the lung. The study showed consistent benefit in hemodynamics with a clinically meaningful average reduction of 14% in systolic pulmonary arterial pressure (sPAP) with acute exposure to iNO. The study also assessed the chronic effects of iNO on exercise capacity showing an average 75 meter improvement in 6-minute walk distance, or 6MWD, and consistent improvement of approximately 80 m% in composite endpoints of 6MWD and oxygen saturation with four weeks of treatment. The study assessed both the iNO 75 and iNO 30 dose, supporting iNO 30 as a potentially safe and effective dose. During August 2017, the company announced FDA acceptance of its investigation new drug application for its Phase 2b study using INOpulse therapy in a broad population of patients with pulmonary fibrosis, or PF, both with and without PH.

In addition, other opportunities for the application of its INOpulse platform include the following indications: chronic thromboembolic PH, or CTEPH, PH associated with sarcoidosis and PH associated with pulmonary edema from high altitude sickness.

Bellerophon has devoted all of its resources to its therapeutic discovery and development efforts, including conducting clinical trials for its product candidates, protecting its intellectual property and the general and administrative support of these operations. Bellerophon has devoted significant time and resources to developing and optimizing its drug delivery system, INOpulse, which operates through the administration of nitric oxide as brief, controlled pulses that are timed to occur at the beginning of a breath. In addition, in prior years, the company incurred significant costs to scale up manufacturing of Bioabsorbable Cardiac Matrix, or BCM, to support its clinical trials.

To date, Bellerophon has generated no revenue from product sales. Bellerophon expect that it will be several years before it commercialize a product candidate, if ever.

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