- Just a week after giving exclusive acquisition rights to Johnson & Johnson, clinical-stage biopharma Bird Rock Bio took the first step to that end, announcing the approval of Phase 1 testing for its investigational drug targeting fibrotic and metabolic disease.
- The trial will assess the biologic namacizumab as a treatment for non-alcoholic fatty liver disease (NAFLD), and receive funding from a collaboration inked in early January between Bird Rock and Johnson & Johnson's research unit Janssen.
- As its name suggests, NAFLD results in the harmful accumulation of fat in the liver. It encompasses non-alcoholic steatohepatitis (NASH), which drugmakers have shown great interest in given its large patient population and lack of any Food and Drug Adminstration-approved treatements.
Poor diet, obesity and high cholesterol can cause NAFLD, though it isn't known to have glaring symptoms. As much 25% of the U.S. population has the disease, according to the American Liver Foundation.
Perhaps due to that fact, the NAFLD/NASH field is buzzing with deals at the moment. In December, Novartis paid $50 million upfront to get an option to Conatus Pharmaceuticals' emricasan. November saw Bristol-Myers Squibb handing over $100 million for Nitto Denko's small interfering RNA (siRNA) ND-L02-s0201. Allergan also bought two companies in the space, Tobira and Akarna.
The two-part Phase 1 trial for namacizumab will test the drug's safety and efficacy, Bird Rock said in a Jan. 11 statement. Additionally, the La Jolla, CA-based biopharma revealed GE Healthcare would help manufacture the treatment for Phase 2 testing.
Johnson & Johnson announced its deal with Bird Rock on Jan. 5 as part of a sweeping group of 15 collaborations with various life science and technology companies aimed at therapeutic areas "of high unmet need." Terms hold that Janssen will provide funding for early- and mid-stage testing, and in exchange get the option to takeover Bird Rock following the Phase 1 study's completion.
Readouts for the two parts of that study are set for the first and third quarter, respectively, of 2017.
Bird Rock did not disclose specific inancials of its deals with Janssen and GE Healthcare.
Namacizumab is an antibody works on the cannabinoid 1 receptor (CB1), which plays a role in the body's nervous system and various feelings such as hunger and pain. Small molecule CB1 modulators have potential for CNS side effects because they can pass across the blood-brain barrier, though namacizumab may have a lower risk of that because it is a large biologic molecule. The drug, which Bird Rock submitted for clinical trial authorization in October, is the first and only of a specific antibody type targeting CB1 receptor to enter clinical trials.