LA JOLLA, Calif., March 16, 2016 /PRNewswire/ -- Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, today 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.
"IL-6 is a well-validated target for RA, and gerilimzumab, a novel anti-IL-6 antibody, has a unique pharmacokinetic profile supporting low and infrequent dosing," said Paul Grayson, CEO of Bird Rock Bio. "With the ability to provide an extremely low dose every other month, we can price gerilimzumab as low as $2,000 per patient, per year. With more than 20 million rheumatoid arthritis patients globally, many of whom do not have access to the most advanced therapies, gerilimzumab represents a tremendous opportunity for innovation to provide affordable access to a best-in-class therapy worldwide. This could save healthcare systems around the world billions of dollars in the future."
Today, the pharmaceutical economic impact for an RA patient who advances to a biologic therapy is $20,000 to $40,000 each year for the rest of their lives. RA patients can be on a biologic therapy for two to three decades, which equates to upwards of a $1 million impact per RA patient on the health system. With more than 20 million RA patients worldwide, health care systems around the world are seeking better ways to provide the best treatments while managing costs.
Mark Genovese, M.D., Professor of Medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center and Director of Bird Rock Bio Gerilimzumab Clinical Advisory Board commented: "As clinicians, we have seen the beneficial impact on patients from the advancements of biologic treatments for RA over the past twenty years. IL-6 inhibitors, specifically, have emerged as a safe and effective class of therapy both as first-line biologic treatments and second line for those patients where TNF-α inhibitors are not effective. The recent clinical findings of gerilimzumab indicate a further large opportunity to increase convenience for patients through less frequent dosing and greatly reduce the current high cost of care of RA."
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.
Tim Van Hauwermeiren, CEO at argenx commented: "The favorable outcomes of the two studies for gerilimzumab represent an exciting step forward for this exceptional antibody. Gerilimzumab was originally discovered by using argenx' SIMPLE Antibody™ platform and has been further differentiated with our proprietary NHance® technology, which prolongs the circulation time and improves tissue distribution of antibodies. We are very pleased with how rapidly and successfully Bird Rock Bio has progressed gerilimzumab."
Joe Zhou, President and CEO of Genor Biopharma, commented: "We are extremely pleased with both the safety and support for infrequent dosing that was demonstrated in these studies for gerilimzumab. There are more than four million RA patients in China; however, the market remains underserved due to high price sensitivity. We view gerilimzumab as a one-of-a-kind potential product that can be priced in a way to enable the moderate to severe RA patients to finally have a best in class treatment."
Gerilimzumab is the result of a unique collaborative model, involving Bird Rock Bio, argenx (Euronext Brussels: ARGX), and Genor Biopharma. 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.
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 NASH and RA. 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.
SOURCE Bird Rock Bio, Inc.