INOpulse (Bellerophon Therapeutics) is a drug-device combination being developed to deliver a continuous, pulsed dose of nitric oxide via intranasal inhalation. The INOpulse delivery system utilizes a technology to deliver pulsatile inhaled nitric oxide, allowing for use in a portable chronic setting.
Bellerophon Therapeutics is developing INOpulse (nitric oxide), a unique drug-device combination that allows for the continuous inhalation of nitric oxide, a well-known vasodilator. The company has hit a roadblock with INOpulse’s development for World Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) due to a recommendation from the data monitoring committee stating that its Phase III trial should be halted for futility. While Bellerophon plans on analyzing the full dataset for PAH, it is likely that the company will be relying on its Phase II development program for WHO group 3 pulmonary hypertension (PH) due to lung disease for alternative success. The drug may possess greater opportunities and commercial prospects in the WHO group 3 patient segment, which is associated with critical unmet need with an absence of approved treatment options. In contrast, Bellerophon’s niche Phase III clinical program for PAH was targeting a restricted subset of patients with high disease burden who were on long-term oxygen therapy (LTOT). Moreover, the PAH segment is already highly saturated with approved therapies, further limiting INOpulse’s potential impact on the market through its targeting of PAH
LIST OF FIGURES
10 Figure 1: INOpulse for pulmonary hypertension – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of INOpulse for pulmonary hypertension
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of INOpulse for pulmonary hypertension
14 Figure 4: INOpulse sales for pulmonary hypertension in the US, 2016–25
LIST OF TABLES
6 Table 1: INOpulse drug profile
7 Table 2: INOpulse Phase III trials in pulmonary arterial hypertension
9 Table 3: INOpulse Phase II data in pulmonary arterial hypertension
10 Table 4: INOpulse Phase II trials in PH-IPF
15 Table 5: INOpulse sales for pulmonary hypertension in the US ($m), 2016–25
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