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When are Phase 2 results due?
About the BHT-II-0002 study
This study has recruited over 300 patients in 35 investigator sites in the USA and the UK. The interim analysis included evaluation of the primary endpoint of the study, which is based on the number of overall responders in each group.The definition of an overall responder is IBS subtype specific and consists of two components. For both IBS subtypes, the first component is the weekly average of abdominal pain intensity. Improvement is defined as a decrease of at least 30% compared with baseline. The second component is different for the two IBS subtypes and relates to stool frequency per week for IBS-C and a reduction in incidence of loose stool consistency for IBS-D compared with baseline. In order for a subject to be classed as a responder, both components must show improvement in the same week for at least 50% of the treatment period of 8 weeks.
About 4D
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's Live Biotherapeutic Products are orally delivered single strains of bacteria that are naturally found in the healthy human gut.?The Company has five clinical studies in progress, namely a Phase II clinical study of BLAUTIX® in Irritable Bowel Syndrome (IBS), 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 and a Phase I/II study of MRx-4DP0004 in asthma. 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.
For more information, refer to https://www.4dpharmaplc.com.
Contact Information:
4D
Duncan Peyton, Chief Executive Officer + 44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0) 20 7496 3000
Aubrey Powell / Justin McKeegan / Alex Bond (Corporate Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500
Dominic Wilson / Phil Walker
Image Box PR
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Auth