4d Pharma PLC - Joins MJFF-sponsored Parkinson’s study consortium

4D pharma Joins Landmark Parkinson's Progression Markers Initiative

A landmark study sponsored by The Michael J. Fox Foundation to better understand Parkinson's disease and accelerate the development of new treatments

4D pharma will play an important role as PPMI considers the microbiome as an area of focus

Leeds, UK, December l8, 2020, - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces that it has joined the Parkinson's Progression Markers Initiative (PPMI) as an industry partner. PPMI is a landmark study sponsored by The Michael J. Fox Foundation to better understand Parkinson's disease and accelerate the development of new treatments.

4D pharma representatives will contribute to the efforts of the PPMI by joining the Partner Scientific Advisory Board closely involved in the design and execution of the study. In addition, 4D pharma will also join a variety of PPMI Working Groups that provide a forum to discuss PPMI data and address Parkinson's clinical trial challenges with other PPMI industry and non-profit partners. 

"The Michael J. Fox Foundation has made considerable contributions to the development of therapeutic solutions for the millions of people with Parkinson's disease. Joining the PPMI Scientific Advisory Board will enable 4D pharma to bring its leading expertise in Live Biotherapeutics and the gut-brain axis to the pioneering joint effort that is the PPMI", said Alex Stevenson, Chief Scientific Officer, 4D pharma. "This is an excellent forum in which to share our knowledge and scientific approach and to help shape the future of high-quality research into Parkinson's disease and other neurodegenerative conditions, while continuing to learn from leading experts in the field across industry, academia and non-profit organisations. 4D pharma will play an important role as PPMI considers the microbiome as an area of focus, following a growing body of evidence pointing to the gut microbiome as a new frontier in our understanding and treatment of Parkinson's disease."

"We are pleased to welcome 4D pharma as a partner on the Parkinson's Progression Markers Initiative. It is only with diverse expertise on the various aspects of this complex disease that we will better understand it and find solutions for patients," said MJFF Deputy CEO, Sohini Chowdhury.  "There is a significant and growing interest in the field in understanding the role of the microbiome in Parkinson's disease and opportunities for therapeutic intervention. 4D pharma brings expertise in this novel area of research to our Scientific Advisory Board, and we look forward to their insights and contributions."

In addition to its contribution to PPMI, 4D pharma continues to make progress with regards to its own pipeline of Live Biotherapeutic candidates for Parkinson's disease. 4D pharma has previously published pre-clinical data demonstrating the neuroprotective effects of Live Biotherapeutics in an animal model of Parkinson's disease, and work investigating the mechanisms of these therapeutic effects.  The Company continues to make progress in the planning and design of a first-in-human clinical trial in Parkinson's disease patients; this would be the first clinical trial of a Live Biotherapeutic in the treatment of Parkinson's.

About the Parkinson's Progression Markers Initiative

PPMI is a landmark observational longitudinal clinical study launched by MJFF in 2010 to help identify, develop, and validate biomarkers of Parkinson's disease progression to further the development of disease-modifying therapies. PPMI is funded by MJFF and a consortium of key industry players, non-profit organizations and private individuals, and involves active participation of stakeholders from government, the biopharmaceutical industry and academia to collectively design, implement and fund this comprehensive and pioneering research program.

PPMI collects and analyses a suite of clinical, imaging and biological data over time to measure and track disease risk, onset and progression, to establish new biomarkers for use in clinical trials of disease-modifying therapies. The study is building on its 33 clinical sites and 1,400 enrolled volunteers, with plans to grow to more than 50 clinical sites in 13 countries and more than 4,000 participants.

For more information and to see 4D pharma's PPMI consortium peers visit https://www.ppmi-info.org/about-ppmi/who-we-are/study-sponsors/ 

About 4D pharma

Founded in February 2014, 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease.  4D has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.

4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programmes, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in patients hospitalised with COVID-19, and Blautix® in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programmes include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

In October 2020 4D pharma announced its intention to merge with Longevity Acquisition Corporation (NASDAQ: LOAC), a special purpose acquisition company (SPAC), and seek a NASDAQ listing.  The merger is expected to be completed and the NASDAQ listing of 4D pharma American Depositary Shares (ADSs) under the ticker symbol 'LBPS' is currently expected to become effective in early 2021, subject to approval of 4D Shareholders and Longevity Shareholders, and the SEC review process. 

For more information, refer to https://www.4dpharmaplc.com.

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