Frazier Healthcare Partners has launched a new biopharmaceutical company called Recida Therapeutics, which will develop new therapies for serious antibiotic-resistant infections, including Pseudomonas aeruginosa, the leading cause of lung infections in cystic fibrosis (CF) patients.
RC-01 is Recida’s lead therapy candidate for multidrug-resistant Gram-negative bacteria, a group of bacteria that have become increasingly resistant to available antibiotic therapies, including the highly resistant Pseudomonas aeruginosa.
RC-01 inhibits the bacterial LpxC enzyme, a key protein involved in the production of a fat molecule, called lipid A, a component of the bacteria’s outer membrane and essential for their survival. In in vitro (in the lab) assays and in animal models infected with different Gram-negative bacteria, RC-01 showed a sustained and fast anti-bacterial activity against multi-drug resistant strains.
Furthermore, in clinical isolates of CF patients infected with Pseudomonas aeruginosa, RC-01 showed high levels of anti-bacterial activity. In animal models infected with the multidrug-resistant Acinetobacter baumannii, associated with hospital-acquired infections and recognized as one of the most difficult bacteria to treat, RC-01 was also effective.
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RC-01, unlike previous LpxC inhibitors, showed excellent preclinical safety and tolerability, and a favorable pharmacokinetics profile (referring to the processing of the therapy into, through, and out of the body), even when administered at high doses.
“We believe RC-01 is an exceptional asset around which to form Recida Therapeutics,” James Ge, MD, PhD, co-founder and CEO of Recida, said in a press release.
“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,” Ge added.
Recida is planning to submit an investigational new drug application for RC-01 to the U.S. Food and Drug Administration by April, with the hopes of having a Phase 1 clinical trial completed this year.
The application is being funded by CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a Boston University global partnership funded by multiple partners — namely the U.S. Biomedical Advanced Research and Development Authority; the Wellcome Trust, U.K.; the U.K. Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund; the Bill & Melinda Gates Foundation; and the National Institute of Allergy and Infectious Diseases.
Recida has licensed the development and marketing rights of RC-01 outside Japan from FUJIFILM Toyama Chemical. The development and commercialization of RC-01 in China is conducted in partnership with MicuRx Pharmaceuticals.
“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,” Socks concluded.