Bird Rock Bio Nears Pivotal Trial of New Biologic Drug for RA

Xconomy San Diego — 

San Diego’s Bird Rock Bio says it is within a few months of submitting its plans in Brazil for a pivotal trial of gerilimzumab, a biologic drug for inflammatory diseases like rheumatoid arthritis (RA).

If the drug can win regulatory approval, Bird Rock Bio said gerilimzumab is expected to be priced at just a fraction of the prices set for leading biologic drugs like adalimumab (Humira) and etanercept (Enbrel), which are frequently prescribed to relieve pain and inflammation in a number of autoimmune diseases.

In a statement this morning, Bird Rock Bio says two recently completed clinical studies showed that its lead drug candidate, a novel monoclonal antibody, is both safe and effective at very low doses—less than 50 milligrams annually. The company says gerilimzumab also would require only one injection every eight weeks, instead of daily or multi-injection regimens.

The dosage is so small (yet still potent) that Bird Rock Bio CEO Paul Grayson says the annual price for gerilimzumab might end up as low as $2,000 per patient—in stark contrast to the $20,000 to $40,000 that RA patients currently pay annually for a biologic drug like adalimuab or tocilizumab (Actemra).

“That’s the real punch to the data set we just generated,” Grayson says. He contends that Bird Rock Bio is addressing one of the most significant issues of our generation by making innovative healthcare therapies more affordable.

“It’s a much bigger healthcare issue than an oncology drug that may extend life by six months,” Grayson adds. “We’re talking about patients who are taking drugs priced at $30,000 to $40,000 a year for 30 or 40 years.”

Grayson says his pricing projections for gerilimzumab are based on a significantly lower cost of production. He estimates that one RA patient would require 30 to 60 milligrams of gerilimzumab annually. Compared with leading biologics for RA, such as Roche’s Actemra or Abbvie’s Humira, Bird Rock Bio says it represents from 1/10th to 1/100th the amount of drug product.

“That means our cost of goods [would be] very, very low,” Grayson says. He estimates that gerilimzumab’s cost of goods would even fall well below the cost of generic versions of leading biologic drugs like Humira.

With about 20 million RA patients worldwide, including more than 1.1 million in the United States, Bird Rock Bio says $35 billion is spent annually on drug therapies for RA.

In the five years since Grayson became CEO, Bird Rock Bio (previously known as RuiYi, and before that, Anaphore) has focused on developing monoclonal antibodies that target G-protein coupled receptors. The company describes gerilimzumab as a novel anti-IL-6 antibody. According to Grayson, Bird Rock Bio has raised about $50 million in venture capital funding from Versant Ventures, 5AM Ventures, GlaxoSmithKline’s SR One venture group, and other investors.

Bird Rock Bio has advanced the development of gerilimzumab through clinical trials in China, under a global collaboration with Belgium’s argenx and Shanghai-based Genor BioPharma. The San Diego company anticipates submitting its plans for a pivotal trial of gerilimzumab to health regulators in Brazil within the first half of this year.

Brazil represents the world’s third-largest RA market, with about 1.3 million RA patients, according to Grayson.

RA Gerilimzumab Infographic (Credit: Bird Rock Bio)

RA Gerilimzumab Infographic (Credit: Bird Rock Bio)