Recida’s lead program, RC-01, is a novel, IND-stage LpxC inhibitor for the treatment of multidrug-resistant gram-negative infections. Recida has licensed development and commercialization rights to RC-01 from FUJIFILM Toyama Chemical Co. Ltd.
for all territories outside Japan. Recida intends to a submit an Investigational New Drug application (IND) for RC-01 to the U.S. Food and Drug Administration (FDA) in the first quarter of 2019.
RC-01 inhibits bacterial LpxC, a key enzyme in Lipid A biosynthesis. Lipid A is a key component of the outer membrane of gram-negative bacteria and is therefore essential for bacterial survival. RC-01 exhibits a broad spectrum of rapid, in vitro and in vivo bactericidal activity against major clinically relevant pathogens such as the Enterobacteriaceae and Pseudomonas aeruginosa.
Notably, it is also very active in vitro against highly resistant P. aeruginosa isolates from patients with cystic fibrosis. In addition, RC-01 is active against Acinetobacter baumannii in animal models of infection. Unlike previous LpxC inhibitors, RC-01 has demonstrated a favorable pharmacokinetic profile with high drug exposures as well as excellent preclinical safety and tolerability across relevant species.
“We believe RC-01 is an exceptional asset around which to form Recida Therapeutics,” said James Ge, MD, PhD, Chief Executive Officer and co-founder of Recida.
“LpxC inhibitors have long been a promising class of antibiotics – and RC-01, if approved, would represent the first truly novel antibiotic class to reach patients and physicians in more than 50 years. We believe the preclinical profile of RC-01 is best-in-class, addresses the shortcomings of prior compounds, and has the potential to be the first LpxC inhibitor to advance into later stages of clinical development.”
CARB-X has awarded Recida up to $4.4M to help fund the preparation of an IND application, a Phase 1 trial to be completed in 2019 and drug product manufacturing to support subsequent Phase 2 studies. CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, https://carb-x.org/) is a Boston University global partnership funded by the U.S.
Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the U.K. Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund, and the Bill & Melinda Gates Foundation, with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH).
Following Recida’s $8.5M Series A financing led by Frazier Healthcare Partners, the company entered into a partnership with MicuRx Pharmaceuticals, Inc. for development and commercialization of RC-01 in the greater China region.
“In order to meet the critical and growing unmet need for novel antibiotics, it is essential to collaborate broadly to advance promising compounds like RC-01,” said David Socks, Executive Chairman of Recida and Venture Partner of Frazier Healthcare Partners. “As a result, we are grateful for our partnerships with FUJIFILM Toyama Chemical and MicuRx as well as funding from CARB-X and Frazier. Together, we look forward to advancing this exciting drug candidate into human clinical development.”
“Frazier is very pleased to once again back James Ge and his co-founders, Vernon Jiang, PhD, George H. Talbot, MD, and Paul Eckburg, MD,” said Patrick Heron, Managing General Partner of Frazier Healthcare Partners. “We have great confidence in the Recida team based on their successful development of important antibiotics including doripenem, ceftaroline, and ceftolozane/tazobactam, as well as significant prior hands-on experience developing other inhibitors of LpxC.”
Source: Company Press Release