Investigational Drug Therapies Currently in Early-Stage Clinical Development for the Treatment of Clostridioides (Clostridium) Difficile Infection Mai-Chi N
EXPERT OPINION ON INVESTIGATIONAL DRUGS https://doi.org/10.1080/13543784.2019.1581763 REVIEW Investigational drug therapies currently in early-stage clinical development for the treatment of clostridioides (clostridium) difficile infection Mai-Chi N. Trana,b, Ravina Kullarc and Ellie J. C. Goldsteind,e aDepartment of Pharmacy, Providence St. John’s Health Center, Santa Monica, CA, USA; bDepartment of Pharmacy, Clinica Juan Pablo Medical Group, Los Angeles, CA, USA; cDoctor Evidence, LLC, Santa Monica, CA, USA; dR M Alden Research Laboratory, Santa Monica, CA, USA; eDavid Geffen School of Medicine, Los Angeles, CA, USA ABSTRACT ARTICLE HISTORY Introduction: Clostridioides (Clostridium) difficile Infection (CDI) is an urgent global threat causing Received 16 August 2018 ~500,000 infections annually in the United States of America (USA) and is associated with a 36% 30- Accepted 8 February 2019 day attributable mortality rate. Despite the availability of three therapeutic agents, CDI recurrence KEYWORDS – – occurs in 20 40% of patients, with a 30 40% second recurrence rate in these patients. Consequently, ACX-362F; DS-2969b; there is a need for novel agents for treating CDI. LFF571; ribaxamase; Areas covered: We searched MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Register of ridinilazole; RBX 2660; Controlled Trials, and ClinicalTrials.gov for agents in early stages of clinical development. CRS3123; MCB3681/ These drugs include ACX-362E, DS-2969b, LFF 571, RBX2660, ribaxamase, ridinilazole that have MCB3837 advanced to at least phase 2 and several other drugs in phase 1 development. Expert opinion: The challenge for these new agents is three-fold: (1) to have a novel approach such as a different target/mechanism of action; (2) be ‘significantly’ better than existing agents in regard to ‘sustained clinical response’; or (3) be priced at a reasonable cost when it comes to market or perhaps all three.
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