BiomX (PHGE) Reports Positive Pulmonary Infection Treatment Data

BiomX Inc. PHGE recently released favorable data from Part 2 of its Phase 1b/2a trial. This trial has assessed the efficacy of the novel phage cocktail, BX004, in treating chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in cystic fibrosis (CF) patients.

The study has been addressed as a 'watershed moment' by experts demonstrating the safety and tolerability of BX004 and its advanced clinical impact.

A Few Words on BX004

The study's controlled, double-blind, randomized design, coupled with the positive clinical evidence, positions phage-based therapy as a potential game-changer in addressing pulmonary infections associated with CF.

More Into the Study

BiomX noted that the study emphasized the improvements in pulmonary function observed after a brief 10-day treatment with BX004. The relative FEV1 improvement and positive outcomes in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain signal a breakthrough in the treatment of chronic pulmonary infections associated with CF.

Endpoints included safety and tolerability, a decrease in P. aeruginosa burden, sputum pharmacokinetics, FEV1, CFQ-R (CF Questionnaire-Revised) and CFRSD-CRISS (Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score).

More specifically, BX004 showcased an impressive 14% conversion to a negative P. aeruginosa sputum culture at the end of treatment (Day 10), a stark contrast to the placebo arm's 0%. This achievement is noteworthy, especially for patients with a decade-long history of P. aeruginosa lung infections.

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Key Highlights of Part 2 Results

Part 2 of the trial involved 34 CF patients.  The phage cocktail exhibited positive clinical effects, particularly in patients with reduced baseline lung function. The reduction in P. aeruginosa levels, especially in patients on standard inhaled antibiotics, exceeded the outcomes observed in Part 1 of the trial.

Advancing Further

Banking on these favorable outcomes, BiomX is currently advancing the BX004 program to a larger, pivotal Phase 2b/3 trial. The decision is contingent on regulatory feedback and the availability of sufficient funding.

Market Prospects

According to an Acumen Research and consulting report, the global Chronic Obstructive Pulmonary Disease (“COPD”) treatment market, valued at $16.78 billion in 2021, is projected to reach $25.37 billion by 2030, witnessing a CAGR of 4.9% from 2022 to 2030.

Factors such as the increasing prevalence of COPD, continuous research and development and rising FDA approvals contribute to market expansion. Despite challenges like patent expirations and the availability of generic alternatives, the market is bolstered by a growing number of COPD cases, a surge in pharmaceutical usage in emerging nations and promising drugs in the pipeline.

Share Price Performance

Over the past year, shares of PHGE have improved 1.1% against the industry’s 3.2% decline.

Zacks Rank and Key Picks

BiomX currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Haemonetics HAE, DexCom DXCM and Insulet PODD. Haemonetics and DexCom each presently carry a Zacks Rank #2 (Buy), and Insulet sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Haemonetics’ stock has decreased 0.5% in the past year. Earnings estimates for Haemonetics have increased from $3.82 to $3.89 in 2023 and $4.07 to $4.15 in 2024 in the past 30 days.

HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.

Estimates for DexCom’s 2023 earnings per share have increased from $1.39 to $1.43 in the past 30 days. Shares of the company have increased 0.1% in the past year compared with the industry’s decline of 4.7%.

DXCM’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.4%. In the last reported quarter, it delivered an average earnings surprise of 47.1%.

Estimates for Insulet’s 2023 earnings per share have increased from $1.61 to $1.91 in the past 30 days. Shares of the company have dropped 36.5% in the past year compared with the industry’s decline of 3.3%.

PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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