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Bellerophon (BLPH) Receives FDA Acceptance to Reduce Study Size

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Bellerophon Therapeutics (BLPH - Free Report) was up 18.04% on Sep 27 after the company announced the FDA’s acceptance of its proposal to reduce the size of its ongoing phase III REBUILD study. The study is evaluating its lead candidate INOpulse for treating fibrotic interstitial lung disease (“fILD”).

However, shares of Bellerophon have plunged 63.2% in the year-to-date period compared with the industry’s decline of 27.3%.

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fILD is a severe progressive disease that causes lung tissue scarring characterized by debilitating functional impairment, poor quality of life and limited life expectancy in patients.

REBUILD is a phase III double-blind, placebo-controlled study being conducted to evaluate the safety and efficacy of INOpulse, a pulsed inhaled nitric oxide therapy, at a dose of 45 mcg/kg ideal body weight, in fILD patients versus placebo. The study’s primary endpoint was decided per an FDA consultation and was fixed on observing the change in Moderate to Vigorous Physical Activity (MVPA) in patients.

The REBUILD study was based on the positive data from Bellerophon’s phase II study demonstrating the safety and efficacy of INOpulse in improving the MVPA, multiple quality of life measures and key hemodynamic parameters.

The company previously intended to enroll 300 patients in the study for a 16-week blinded treatment period. However, the company has now decided to reduce the study size. The study’s independent Data Monitoring Committee (DMC) also supported the company’s decision to reduce its study size from 300 to 140 subjects. The decision was made following the evaluation of baseline MVPA characteristics and the safety data of the randomized subjects in the ongoing study.

The study’s primary objective, which is to maintain a power of more than 90% of MVPA based on the effect size observed in the phase II study of the candidate, remains unchanged.
With the reduction in the study size, Bellerophon expects to complete the enrollment in the phase III study by the first quarter of 2023. It also anticipates that the study’s top-line data will be made available by the third quarter of 2023.

Investors must note that apart from being evaluated in fILD, including pulmonary hypertension (“PH”) associated with idiopathic pulmonary fibrosis (“PH-IPF”) and other pulmonary fibrosing diseases, INOpulse is being evaluated for treating PH associated with sarcoidosis (“PH-Sarc”) and PH associated with chronic obstructive pulmonary disease (“PH-COPD”).  

In March 2020, the FDA also granted INOpulse an emergency expanded access (EA) to be a supportive treatment option for COVID-19 patients.


Zacks Rank and Stocks to Consider

Bellerophon currently has a Zacks Rank #2 (Buy).

Some similar-ranked stocks in the same sector include Aridis Pharmaceuticals (ARDS - Free Report) , Immunocore (IMCR - Free Report) and Satsuma Pharmaceuticals (STSA - Free Report) , each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.

ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.

Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.

Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the remaining occasion. The average earnings surprise for IMCR is 33.28%.

Satsuma’s loss per share estimates for 2022 remained steady at $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.

Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.

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