CJRB-402 / 4D Pharma, CJ Biosci - LARVOL DELTA

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1 | N=34 | Terminated | Sponsor: 4D pharma plc | Phase classification: P1/2 ➔ P1

Phase classification • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CD14 • CXCL1 • IL17A • IL1A • IL1B • IL6 • PTPRC • TSLP

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2 | N=34 | Terminated | Sponsor: 4D pharma plc | N=120 ➔ 34 | Trial completion date: Sep 2022 ➔ Apr 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2022 ➔ Apr 2023; Sponsor insolvency

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Immune Modulation • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2 | N=120 | Active, not recruiting | Sponsor: 4D pharma plc | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immune Modulation • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability and Preliminary Signals of Activity in Adult Patients with Partly Controlled Asthma Treated with Live Biotherapeutic MRx-4DP0004 as an Add-On Maintenance Therapy to Inhaled Corticosteroids (ICS) With or Without Long-Acting Beta Agonists (LABA) (ATS 2022) - P1/2 | "Part A of the study generated preliminary signals of clinical activity compared to placebo. Part B of the study will assess clinical and biomarker activity."

Clinical • Late-breaking abstract • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

4D Pharma Announces Positive Topline Results From Part a of Phase I/II Trial of MRx-4DP0004 for the Treatment of Asthma (Businesswire) - P1/2, N=120; NCT03851250; Sponsor: 4D pharma plc; "4D pharma...today announces positive topline results from Part A of phase I/II clinical trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic being developed for the treatment of asthma....The primary endpoint of Part A was to evaluate the safety and tolerability of MRX-4DP0004 with secondary endpoints evaluating clinical activity....Part A met the primary endpoint and the safety profile of MRx-4DP0004 was comparable to placebo....Part B is expected to enroll up to 90 patients, informed by the clinical signals identified in Part A."

P1/2 data • Asthma • Respiratory Diseases

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2; N=120; Recruiting; Sponsor: 4D pharma plc; Trial completion date: Feb 2022 ➔ Sep 2022; Trial primary completion date: Aug 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Immune Modulation • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2; N=120; Recruiting; Sponsor: 4D pharma plc; N=90 ➔ 120

Clinical • Enrollment change • Asthma • Immune Modulation • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19 (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: 4D pharma plc; N=90 ➔ 0; Trial completion date: Sep 2020 ➔ Jan 2021; Recruiting ➔ Withdrawn; Trial primary completion date: Aug 2020 ➔ Dec 2020

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

4D pharma Completes Enrollment of Part A of the Phase I/II Trial of MRx-4DP0004 for the Treatment of Asthma and Provides Program Update (Businesswire) - "4D pharma plc...announces the completion of its target enrollment of 30 patients for Part A of its Phase I/II clinical trial of MRx-4DP0004 in patients with partly-controlled asthma. Following the completion of enrollment of Part A, 4D pharma expects to announce topline results from these patients in the second half of 2021. 4D pharma also announces the voluntary discontinuation of enrollment in the Phase II study of MRx-4DP0004 for the treatment of hospitalized patients with COVID-19 in the UK, in order to focus on its core LBP pipeline candidates due to the increase in vaccination rates, declining hospitalization rates, and progress in the MRx-4DP0004 asthma clinical trial."

Enrollment status • P1/2 data • Asthma • Novel Coronavirus Disease • Respiratory Diseases

4D Pharma Announces Private Placement (Businesswire) - "4D pharma plc...announces it has entered into Securities Purchase Agreements with a select group of U.S. and United Kingdom institutional investors and accredited investors to raise, in aggregate, approximately $24.03 million (£17.29 million) in a private placement...The proceeds from the Fundraising will be used primarily...to evaluate designs for a potential first-in-human clinical trial of MRx0029 in-patient clinical trial in neurodegenerative diseases such as Parkinson’s disease...to complete a Phase II trial of MRx-4DP0004 to prevent or reduce the hyper-inflammatory response in hospitalized patients with COVID-19; to complete ongoing Phase I/II study of MRx-4DP0004 in poorly controlled asthma in combination with existing long-term maintenance therapy."

Financing • New trial • Asthma • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Parkinson's Disease • Respiratory Diseases

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: 4D pharma plc; Trial completion date: Sep 2020 ➔ Feb 2022; Trial primary completion date: Sep 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Asthma • Immune Modulation • Immunology • Inflammation • Respiratory Diseases

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19 (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: 4D pharma plc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

A study to test the effectiveness and safety of bacteria called Bifidobacterium breve in patients with COVID-19 infections (clinicaltrialsregister.eu) - P2; N=90; Ongoing; Sponsor: 4D pharma plc

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19 (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: 4D pharma plc

Clinical • New P2 trial • Immune Modulation • Immunology • Infectious Disease • Novel Coronavirus Disease