- RYI-018 is a first-in-class and only-in-class negative allosteric modulating antibody (NAMA) that stabilizes the cannabinoid 1 receptor (CB1) in an inactive conformation.
- RYI-018 is being developed to treat large unmet medical needs in fibrotic, inflammatory, and metabolic disease, including non-alcoholic steatohepatitis (NASH) and diabetic nephropathy.
- The double blind, placebo controlled, single ascending dose study in healthy volunteers has been completed with no severe or serious adverse event observed at any dose and favorable pharmacokinetics.
- The double blind, placebo controlled, multiple ascending dose study will be conducted in non-alcoholic fatty liver disease (NAFLD) patients, assessing outcomes of key biomarkers.
La Jolla, CA, June 5, 2017 — Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, announced today that it has completed the single ascending dose, Phase 1 clinical trial for RYI-018, also known as RYI-018 or JNJ-2463, a novel therapeutic antibody to the cannabinoid 1 receptor (CB1). In addition, the safety, tolerability, and pharmacokinetics (PK) profile allowed the company to finalize the clinical protocol for the double blind, placebo controlled, multiple ascending dose study to be conducted in non-alcoholic fatty liver disease (NAFLD) patients, assessing outcomes of key biomarkers.
“This first in human (FIH) study of RYI-018 provides important safety, tolerability and PK data,” said Paul Grayson, Bird Rock Bio’s CEO. “No serious adverse events were observed and few minor, non-dose dependent, adverse events were observed at any dose level. Furthermore, the initial half-life data provided supports a favorable dose schedule for future trials.”
RYI-018, a first-in-class and only-in-class negative allosteric modulating antibody (NAMA) stabilizes the inactive conformation of CB1. Significant historic data has shown that CB1 modulation has the potential to intercept NASH through multiple, observable mechanisms.
Bird Rock Bio announced a collaboration and option agreement with Janssen Pharmaceuticals, Inc. in January 2017 pursuant to which Janssen has an exclusive option to acquire the company following the Phase 1 data readout. “Janssen’s expertise in the development, manufacture, and commercialization of biologic therapeutics has already enhanced the development of RYI-018,” added Grayson. “We look forward to initiating the multiple ascending dose portion of the trial in patients with NAFLD in the very near future.”
About RYI-018 (RYI-018, JNJ-2463)
Discovered internally through Bird Rock Bio’s proprietary iCAPS platform, RYI-018 is the first and only known NAMA to the CB1 receptor to be entering clinical trials. RYI-018 is a multi-modal therapeutic candidate with fibrotic, inflammatory and metabolic mechanisms of action. This provides for the opportunity for RYI-018 to have significant potential across a broad range of fibrotic and metabolic diseases including large unmet medical conditions such as NASH and diabetic nephropathy.
Bird Rock Bio’s iCAPS platform, the leading GPCR allosteric antibody drug discovery platform, can isolate and present functional GPCRs in the correct conformation to identify selective monoclonal antibody allosteric modulators. GPCRs are a valuable class of drug targets but have been largely unexplored in antibody discovery because of the difficulty in isolating GPCRs in the correct conformation and functional form.
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