Corbus Pharmaceuticals has acquired from Jenrin Discovery more than 600 compounds designed to target the endocannabinoid system, including CRB-4001 for the treatment of fibrotic diseases affecting the lungs, liver, heart, and kidney.
The endocannabinoid system is associated with the resolution (or shutting off) of the inflammatory response, which is overactive in some inflammatory and fibrotic diseases.
Under the terms of the exclusive licensing agreement, Corbus obtained worldwide commercialization rights of Jenrin’s compound library, as well as a portfolio of issued and pending patents.
CRB-4001 is a second generation of CB1 inverse agonist investigational agent that was designed specifically to prevent penetration of the blood-brain barrier, restricting its effects to the peripheral organs and tissues. First-generation CB1 inverse agonists are associated with neuropsychiatric issues.
This investigational agent was developed in collaboration with the National Center for the Advancement of Translational Science (NCATS), a part of the National Institutes of Health (NIH), which conducted and sponsored its preclinical studies.
CRB-4001’s investigational new drug (IND)-enabling studies were led by George Kunos, MD, PhD, who is scientific director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Kunos is going to join Corbus’s scientific advisory board as an uncompensated member.
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The preclinical studies of the drug were performed in animal models of non-alcoholic fatty liver disease (NAFLD), type 2 diabetes, diet-induced insulin resistance, and type 2 diabetic nephropathy.
Following the completion of an initial Phase 1 study by Corbus in 2019, Kunos is planning to launch a Phase 2 proof-of-concept clinical study on CRB-4001 at the NIH. According to the company, more specific details on the future plans of the clinical development of CRB-4001 will be announced before the end of the year.
“Our now expanded pipeline is built on robust underlying science based on the endocannabinoid system as a master regulator of inflammation and fibrosis in the body,” Yuval Cohen, PhD, CEO of Corbus, said in a press release.
“Plans are underway to advance one of the pipeline candidates, CRB-4001, into a Phase 1 safety study before commencing a NIH-funded first-in-patient Phase 2 study,” he added.
Supported by data from these studies, Corbus believes that CRB-4001 holds significant potential to treat idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction, and nonalcoholic steatohepatitis (NASH), among other disorders.
Corbus also is evaluating in clinical trials the potential of lenabasum — a synthetic small-molecule, selective endocannabinoid system receptor agonist — for the treatment of systemic sclerosis, dermatomyositis, and pulmonary exacerbations in cystic fibrosis patients.
“As we have demonstrated with lenabasum, rational drug design of synthetic compounds can be applied to target the endocannabinoid system in specific ways, with the potential to optimize clinical benefits and reduce side effects,” said Mark Tepper, PhD, president and chief scientific officer of Corbus.
“Beyond lenabasum and CRB-4001, Corbus now has a pipeline that we believe will support the advancement of one to two new drug candidates into clinical testing each year starting in 2020,” Tepper said.