BX004 / BiomX - LARVOL DELTA

Study With Phage for CF Subjects With Pseudomonas Lung Infection (clinicaltrials.gov) - P2 | N=63 | Recruiting | Sponsor: BiomX Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BMX-04-001: Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection (clinicaltrials.gov) - P1/2 | N=43 | Completed | Sponsor: BiomX, Inc. | Active, not recruiting ➔ Completed | Phase classification: P1b/2a ➔ P1/2 | N=32 ➔ 43

Enrollment change • Phase classification • Trial completion • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Phage therapy with nebulized cocktail BX004-A for chronic Pseudomonas aeruginosa infections in cystic fibrosis: a randomized first-in-human trial. (PubMed, Nat Commun) - P1b/2a | "However, due to the study's small sample size, definitive conclusions regarding efficacy are limited. These data pave the way toward further development of novel phage-based therapeutics in antibiotic-resistant pulmonary bacterial infections."

Clinical • Journal • P1 data • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Study With Phage for CF Subjects With Pseudomonas Lung Infection (clinicaltrials.gov) - P2 | N=63 | Not yet recruiting | Sponsor: BiomX Ltd

New P2 trial • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BiomX Announces a Series of Financings for Aggregate Gross Proceeds of $12 Million (GlobeNewswire) - "BiomX Inc...today announced that it has entered into a securities purchase agreement with investors in connection with a registered direct offering, concurrent private placement of the Company’s securities, and simultaneous exercise of certain existing common stock purchase warrants (collectively, the 'Offerings') for expected aggregate gross proceeds of approximately $12 million to the Company, before deducting placement agent fees and other offering expenses...'Following these offerings, we expect to have sufficient funding to reach substantial inflection points including topline results of our Phase 2b study of BX004 in Q1 2026 and our Phase 2 readout for BX211 in Diabetic Foot Osteomyelitis later this quarter..."

Financing • P2 data • P2b data • Cystic Fibrosis • Infectious Disease

BiomX Announces Third Quarter 2024 Financial Results and Provides Business and Program Updates (GlobeNewswire) - "BX004 Phase 2b study in Cystic Fibrosis (CF) is now expected to report topline results in H1 2026 following resolved manufacturing delays....Research and development expenses, net were $7.3 million for the third quarter of 2024, compared to $5.6 million for the third quarter of 2023. The increase was primarily due to the following factors: preparations for the Phase 2b clinical trial of the Company’s CF product candidate, BX004..."

Commercial • P2b data • Cystic Fibrosis • Infectious Disease

Safety and efficacy of nebulized phage in CF patients with chronic Pseudomonas aeruginosa pulmonary infection: A phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study (NACFC 2024) - "Background: Pseudomonas aeruginosa persists in most people with cystic fibrosis (PwCF) despite improvements observed with the most-effective CF transmembrane conductance (CFTR) modulator (elexacaftor/tezacaftor/ ivacaftor [ETI]) [1]... This randomized, double-blind, placebo-controlled, multicenter study evaluated nebulized BX004-A in 43 outpatient adults with CF with clinically stable lung disease (FEV1 ≥40%) and chronic P. aeruginosa pulmonary infection taking inhaled antibiotics (tobramycin, aztreonam, or colistin) with sputum P. aeruginosa of ≥105 CFU/g, and with all screening P. aeruginosa morphotypes susceptible to one or more phages in BX004-A... BX004-A showed favorable safety and notable microbiologic and clinical efficacy in Part 2, with more-pronounced microbiologic reduction than in Part 1."

Clinical • P1/2 data • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BiomX to Provide Latest Update on Positive Phase 1b/2a Clinical Trial Data for BX004 at the North American Cystic Fibrosis Conference (GlobeNewswire) - P1/2 | N=32 | NCT05010577 | Sponsor: BiomX, Inc. | "BiomX....announces the Company will present further data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections....Study data shows results from the two-part study where in Part 1, subjects receiving the BX004-A cocktail showed a greater reduction in P. aeruginosa (PsA) colony-forming units (CFU)/g of sputum at day 15 vs. baseline, compared to placebo. Importantly, in Part 2 of the trial, in subjects with quantitative sputum PsA CFU at baseline, 14% of subjects receiving BX004-A had a negative PsA sputum culture on day 10 (end of treatment), compared to placebo (0%).... As of these data being presented, all study subjects have completed the six-month follow up."

P1/2 data • Cystic Fibrosis

Novel nebulized phage cocktail in CF patients with chronic P. aeruginosa pulmonary infection: a Ph1b/2a randomized, double-blind, placebo-controlled trial (ERS 2024) - "Objectives: Pseudomonas aeruginosa (PsA) causes pulmonary infections in cystic fibrosis (CF) patients, despite use of elexacaftor/tezacaftor/ivacaftor (ETI). BX004-A showed favorable safety and notable microbiologic and clinical efficacy. Next study will assess longer treatment."

Clinical • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Respiratory Diseases

BiomX to Present Positive Phase 1b/2a Clinical Trial Data for BX004 at the European Respiratory Society (ERS) Congress 2024 (GlobeNewswire) - P1/2 | N=32 | NCT05010577 | Sponsor: BiomX, Inc. | "BiomX Inc...announces the Company will present data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented as a poster at the European Respiratory Society (ERS) Congress in Vienna, Austria taking place September 7-11, 2024....Importantly, in part two of the trial, 14% of subjects receiving BX004-A had a negative PsA sputum culture on day 10 (end of treatment), compared to placebo (0%). In addition, lung function, as measured by forced expiratory volume in 1 second (FEV1), increased in subjects receiving the cocktail (+5.66%) compared to placebo (-3.23%), in the subgroup on continuous inhaled antibiotics (same antibiotic with no cycling or alternating regimen), on ETI and with lower lung function (FEV1 <70%)."

P1/2 data • Cystic Fibrosis • Genetic Disorders • Infectious Disease

BiomX Reports Second Quarter 2024 Financial Results and Provides Business and Program Updates (GlobeNewswire) - "Research and development expenses, net were $6.9 million for the second quarter of 2024, compared to $3.8 million for the second quarter of 2023. The increase was primarily due to preparations for Phase 2b in the clinical trial of our CF product candidate, BX004..."

Commercial • Cystic Fibrosis

Safety and efficacy of a nebulized phage cocktail in cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection: a phase 1b/2a randomized, double-blind, placebo-controlled study (ECFS 2024) - "Objectives : Pseudomonas aeruginosa (Pa) continues to be associated with pulmonary exacerbations in people with cystic fibrosis (PwCF) even in the era of elexacaftor/tezacaftor/ivacaftor (ETI)...Methods : Nebulized BX004-A was evaluated in a Ph1b/2a randomized, double-blind, placebo-controlled, multicenter study in 43 adult PwCF with FEV 1 ≥40% and chronic Pa pulmonary infection on inhaled antibiotics (tobramycin, aztreonam, or colistin) with Pa susceptible to at least 1 phage in BX004-A...During treatment, there were no adverse events of special interest or serious adverse events. Conclusion : BX004-A showed favorable safety and notable microbiologic and clinical efficacy."

Clinical • P1/2 data • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BiomX to Present Phase 1b/2a Clinical Trial Data for BX004 at the 47th European Cystic Fibrosis Conference and at ASM Microbe 2024 (GlobeNewswire) - "BiomX...today announced the Company will present at two upcoming conferences data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections....The findings will be presented in an oral presentation and an ePoster at the 47th European Cystic Fibrosis Conference, which is taking place June 5-8, 2024..."

P1/2 data • Cystic Fibrosis

BiomX Reports First Quarter 2024 Financial Results and Provides Business and Program Updates (GlobeNewswire) - "Phase 2b trial results for BX004, a fixed multi-phage cocktail for the treatment of cystic fibrosis ('CF') patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa), are expected in the third quarter 2025."

P2b data • Cystic Fibrosis • Infectious Disease

Sputum Pharmacokinetics of a Nebulized Phage Cocktail in Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Pulmonary Infection: A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study (ASM Microbe 2024) - " A Ph1b/2a randomized, double-blind, placebo-controlled, multicenter study evaluated nebulized BX004-A in 43 adult PwCF with FEV1 ≥40% and chronic Pa pulmonary infection on inhaled antibiotics (tobramycin, aztreonam, or colistin) with Pa susceptible to at least 1 phage in BX004-A. BX004-A showed favorable safety and notable microbiologic efficacy with detectable phage in the sputum of all subjects during phage therapy.$$graphic_{41D3894D-722E-43C6-BEAA-6C2CFB110049}$$$$graphic_{A9F9BB6A-DE65-4FE0-8B77-EB5888CD9FB5}$$$$graphic_{73F2D3F4-55F8-44DE-9BD5-782D44902ED5}$$"

Clinical • P1/2 data • PK/PD data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Sputum Pharmacokinetics of a Nebulized Phage Cocktail in Cystic Fibrosis Patients with Chronic Pseudomonas Aeruginosa Pulmonary Infection: A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study (ASM Microbe 2024) - " A Ph1b/2a randomized, double-blind, placebo-controlled, multicenter study evaluated nebulized BX004-A in 43 adult PwCF with FEV1 ≥40% and chronic Pa pulmonary infection on inhaled antibiotics (tobramycin, aztreonam, or colistin) with Pa susceptible to at least 1 phage in BX004-A. BX004-A showed favorable safety and notable microbiologic efficacy with detectable phage in the sputum of all subjects during phage therapy."

Clinical • P1/2 data • PK/PD data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BiomX to Present Data from Phase 1b/2a Study of BX004 for the Treatment of Cystic Fibrosis Patients with Chronic Pulmonary Infections at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024) (GlobeNewswire) - "BiomX Inc...announced the Company will present data from the Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections at ECCMID 2024, which is being held from 27-30 April 2024, in Barcelona, Spain. The abstract submitted by the Company was selected as a 'Top Poster', ranking it among the 1-2% of top-rated abstracts in the category submitted and accepted at ECCMID 2024."

P1/2 data • Cystic Fibrosis • Infectious Disease

BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Research and development expenses, net were $16.7 million for the year ended December 31, 2023, compared to $16.2 million for the prior year. The increase was primarily attributed to an increase in expenses related to conducting the clinical trial of the Company’s CF product candidate, BX004."

Commercial • Cystic Fibrosis

BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing (GlobeNewswire) - "The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses....The proceeds from the private placement are expected to provide funding through the results from a planned Phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in CF patients expected in the third quarter of 2025..."

M&A • P2b data • Cystic Fibrosis

BiomX Announces Closing of the Acquisition of Adaptive Phage Therapeutics and Concurrent $50 Million Financing (GlobeNewswire) - "Acquisition creates leading phage therapy company with an advanced pipeline that includes two Phase 2 assets, BX004 for the treatment of chronic pulmonary infections in cystic fibrosis ('CF') patients...'We also appreciate the continued support of leading institutional healthcare investors. Through this financing, we expect to have sufficient capital to reach multiple data readouts in CF and DFO over the next 12-24 months.'"

M&A • P2 data • Cystic Fibrosis

BiomX Receives Orphan Drug Designation from the U.S. Food and Drug Administration for BX004 for the Treatment of Chronic Pulmonary Infection Caused by Pseudomonas aeruginosa in Patients with Cystic Fibrosis (GlobeNewswire) - "BiomX Inc...today announced that its phage cocktail, BX004, has been granted Orphan Drug Designation ('ODD') by the United States Food and Drug Administration ('FDA'), for the treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis ('CF')."

Orphan drug • Cystic Fibrosis • Genetic Disorders • Infectious Disease

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis (GlobeNewswire) - "P1/2 | N=32 | NCT05010577 | Sponsor: BiomX, Inc. | "BiomX Inc....today announced positive safety and efficacy results from Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis ('CF')...'BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV11 improvement (5.67% at Day 17, 1 week after end of treatment) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (8.87 points at Day 17) in a predefined subgroup of patients with reduced lung function'...the Company plans to advance the BX004 program to a larger, pivotal Phase 2b/3 trial...Study drug was safe and well-tolerated, with no related SAEs (serious adverse events) or related APEs (acute pulmonary exacerbations) to study drug."

P2 data • Cystic Fibrosis

A phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study evaluating nebulized phage therapy in cystic fibrosis subjects with chronic Pseudomonas aeruginosa pulmonary infection (NACFC 2023) - "Even after treatment with the most-effective CFTR modulator available (elexacaftor-tezacaftor-ivacaftor), most people remain infected with P. aeruginosa [2]... This randomized, double-blind, placebo-controlled, multicenter study is evaluating nebulized BX004-A in 32 outpatient adults with CF with clinically stable lung disease (ppFEV1 ≥40%) and chronic P. aeruginosa pulmonary infections taking inhaled antibiotics (tobramycin, aztreonam, or colistin) with all screening P. aeruginosa morphotypes susceptible to one or more phages in BX004-A... This ongoing clinical trial is assessing the safety and efficacy of BX004-A in people with CF with chronic P. aeruginosa pulmonary infection. All subjects in Part 1 had high levels of screening P. aeruginosa, with all morphotypes susceptible to the BX004-A phage cocktail. Part 1 topline results showed that the study drug was well tolerated and had promising microbiologic efficacy in BX004-A-treated subjects."

Clinical • P1/2 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

BiomX to Present Data from Ongoing Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Pseudomonas aeruginosa Pulmonary Infections in Patients with Cystic Fibrosis at the 37th Annual North American Cystic Fibrosis Conference (GlobeNewswire) - "BiomX...today announced that the Company will present data from Part 1 of its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic Pseudomonas aeruginosa (PsA) pulmonary infections in people with cystic fibrosis ('CF') at the 37th Annual North American Cystic Fibrosis Conference, which is being held November 2-4, 2023, in Phoenix, Arizona....The poster will also be made available on the publications section of the BiomX website on November 3, 2023."

P1 data • Cystic Fibrosis

BiomX to Present Data from Ongoing Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Pseudomonas aeruginosa Pulmonary Infections in Patients with Cystic Fibrosis at the European Respiratory Society (ERS) International Congress 2023 (GlobeNewswire) - "BiomX...today announced that the Company will present data from Part 1 of its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic Pseudomonas aeruginosa (PsA) pulmonary infections in patients with cystic fibrosis ('CF') at European Respiratory Society (ERS) International Congress 2023, which is being held September 9-13, 2023, in Milan, Italy....The poster will also be made available on the publications section of the BiomX website on September 10, 2023."

P1 data • Cystic Fibrosis • Infectious Disease