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A small phase 1b trial of NovoBioJect — a combo of low-dose methotrexate and novobiocin — showed a 38% boost in the drug's active forms inside immune cells compared to methotrexate alone. The approach works by blocking a transporter that normally flushes methotrexate out of cells before it can act. Experts are cautiously intrigued, with a phase 2 trial now in the planning stages.
A methotrexate upgrade could be on the horizon — if the early data holds up
Methotrexate has been a cornerstone of autoimmune disease treatment for decades, but it has a frustrating flaw: a cellular transporter called ABCG2 pumps it out of immune cells before it can do its job. Enter NovoBioJect, an investigational drug from Amplio Pharma that pairs low-dose methotrexate with low-dose novobiocin — an old antibiotic repurposed as a "pharmacokinetic enhancer" — to block that efflux and keep the drug where it's needed.
In a phase 1b open-label study of just 12 rheumatoid arthritis patients, a single subcutaneous injection of NovoBioJect produced a 38% increase in the accumulation of methotrexate's active intracellular forms compared to methotrexate alone. Safety signals were reassuring, with only mild injection-site reactions and no changes in liver enzymes, kidney function, or plasma methotrexate levels.
Key Takeaways:
Why it matters: Millions of patients with rheumatoid arthritis and other autoimmune conditions fail or become intolerant to methotrexate. A safe, effective booster could delay or replace the need for expensive biologics — but the field will need phase 2 data before drawing firm conclusions.
