Bird Rock Bio Completes Single Ascending Dose Human Clinical Trial for Namacizumab; Generates Safety, Tolerability, and Pharmacokinetics Data; Prepares To Initiate Study in Non-Alcoholic Fatty Liver Disease Patients

  • Namacizumab 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.
  • Namacizumab 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 namacizumab, 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 namacizumab 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.”

 

Namacizumab, 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 namacizumab,” 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 Namacizumab (RYI-018, JNJ-2463)

Discovered internally through Bird Rock Bio’s proprietary iCAPS platform, namacizumab is the first and only known NAMA to the CB1 receptor to be entering clinical trials.  Namacizumab is a multi-modal therapeutic candidate with fibrotic, inflammatory and metabolic mechanisms of action.  This provides for the opportunity for namacizumab to have significant potential across a broad range of fibrotic and metabolic diseases including large unmet medical conditions such as NASH and diabetic nephropathy.

 

About iCAPS

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.

 

About Bird Rock Bio, Inc.

Backed by leading biotechnology venture investors, Bird Rock Bio’s strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class or best-in-class molecules with strong clinical and commercial differentiation.  The Company is focused on developing proprietary antibodies for fibrotic, metabolic and inflammatory diseases, including RA, SA, NASH and diabetic nephropathy.  Bird Rock Bio’s science team is experienced with translating pioneering research into promising therapeutics with potential deep pharmacoeconomic benefits.  For more, visit www.birdrockbio.com.

 

Media Contact:  Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091