Date: 2016-03-16
Type of information: Results
phase: 1
Announcement: results
Company: Bird Rock Bio, previously RuiYi (USA - CA)
Product: gerilimzumab
Action
mechanism: monoclonal antibody. Gerilimzumab is an anti-interleukine-6 (IL-6) monoclonal antibody. In late 2012, Bird Rock Bio entered into a collaboration for the worldwide rights to gerilimzumab from ArgenX , a biopharmaceutical company focused on creating and developing differentiated antibodies for the treatment of cancer and severe autoimmune diseases. Early in 2013, Bird Rock Bio partnered gerilimzumab with Genor Biopharma for IND enablement, manufacturing process development and commercialization for China. Bird Rock Bio has retained all other commercial rights of gerilimzumab for the rest of the world.
Disease:
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On March 16, 2016 I Bird Rock Bio announced positive results from two clinical studies assessing the safety and pharmacokinetics of gerilimzumab, a novel anti-IL-6 cytokine antibody for the treatment of inflammatory diseases, including rheumatoid arthritis (RA). In both studies, gerilimzumab demonstrated safety as well as pharmacokinetic support for very low (less than 50 mg per patient, per year) and infrequent (one subcutaneous injection every eight weeks) dosing, which is anticipated to enable an extremely low annual price as low as $2,000 per patient. Bird Rock Bio plans to complete submission for a pivotal trial for RA by the first half of this year. The two clinical studies in healthy adult volunteers focused on the pharmacokinetics of gerilimzumab in single and multiple ascending doses respectively to validate its pharmacology and potential pharmacoeconomic profile. In the single ascending dose study, gerilimzumab was administered by subcutaneous injection at four dosages (1 mg, 5 mg, 15 mg, and 30 mg) and in the multiple ascending dose study, gerilimzumab was administered by subcutaneous injection at two dosages (5 mg and 20 mg) once per month for three months. A total of 50 subjects were included in both studies, which also assessed the safety and tolerability of gerilimzumab compared with placebo. In both studies, gerilimzumab was well tolerated, and no serious adverse events were reported. The average half-life of gerilimzumab observed in the two studies was approximately 50 days, supporting a proposed dosing regimen of 5 mg to 10 mg once every eight weeks. Compared with leading biologics for RA such as Roche's Actemra or Abbvie's Humira, this represents 1/10th to 1/100th the amount of drug product. With this data, gerilimzumab presents the opportunity for a dramatically reduced price for therapy while offering patients much greater convenience with just six doses per year.
