Amplio Pharma Reported Positive Phase 1b Arthritis Data
The drug candidate NovoBioJect increased intracellular methotrexate levels in patients during a clinical trial.
Updated on Oct. 7, 2026 in Arthritis
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Amplio Pharma has released results from a phase 1b study showing that its arthritis drug candidate, NovoBioJect, significantly boosted intracellular methotrexate polyglutamate levels. The study measured these markers in 12 patients with rheumatoid arthritis.
Why it matters
By blocking the ABCG2 efflux transporter, this combination therapy aims to improve drug retention in immune cells. This approach could potentially enhance the effectiveness of methotrexate, a standard treatment for rheumatoid arthritis.
A single dose of NovoBioJect increased intracellular MTX polyglutamates by 38% compared to methotrexate alone, a result found to be statistically significant with a P-value of 0.009 in the 12-patient sample.
The players
Amplio Pharma
This pharmaceutical company focuses on the development of novel drug candidates for the treatment of inflammatory and autoimmune conditions.
The details
NovoBioJect works by combining low-dose methotrexate with subcutaneous novobiocin doses of 80mg, 150mg, or 200mg. While the assessment identified mild, dose-dependent injection-site reactions, researchers reported no other treatment-related adverse events.
Timeline
In October 2026, the company reported phase 1b study results.
The full phase 1b dataset was presented in 2026 at ACR Convergence.
Amplio expects to begin a phase 2a study in 2027.
The Big Picture
This research follows the pattern set by other novel therapies presented at the ACR Convergence research summit, where major rheumatology advancements are disseminated to the global medical community.
For individuals managing rheumatoid arthritis, this trial represents a potential shift toward more effective use of existing methotrexate regimens. Patients should note that this drug is currently in clinical trials and remains unavailable for prescription use.
The takeaway
This trial highlights a promising method for enhancing the intracellular retention of common anti-rheumatic drugs. Future studies will determine if this biomarker success translates into meaningful symptom relief for those living with the disease.
What happens next
Amplio Pharma plans to launch a phase 2a study of NovoBioJect involving 100 newly diagnosed rheumatoid arthritis patients in 2027, provided the company secures its targeted €10 million in Series A financing.
Further reading
Learn more about the latest research in this field on our Arthritis page.
Source note: This article includes information reported by Pharmafile.
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