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One in 10 people suffer from one of the 80 distinct chronic autoimmune disease, or immune-mediated inflammatory disease (IMID), ranging from the more common plaque psoriasis, rheumatoid arthritis or Crohn's disease to orphan diseases like systemic sclerosis or sarcoidosis

There is a clear unmet medical need  with the available drugs failing to successfully treat many of these patients to disease remission.


Methotrexate is the 1st line, cornerstone drug treatment to treat most of the chronic autoimmune disease. However, to be optimally effective, it needs to be retained in the pro-inflammatory cells long enough to be poly-glutamated by intracellular enzymes.

Novobiocin can successfully trap methotrexate in the cells by blocking the efflux protein ABCG2.

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To develop new drug product a comprehensive team of experts is needed!

For Methotrexate Forte, we have been able to recruit an international advisory teams of experts bringing the necessary expertise from all the areas needed to successfully develop a drug product, including leading rheumatologists.


"We firmly believe, that the effort to amplify the efficacy/safety of methotrexate through the addition of an ABCG2 PK-enhancer and the repurposing of the natural compound novobiocin, is in very capable hands"- M. Mensonides-Harsema, CEO Amplio Pharma BV.

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For Methotrexate Forte to come to the market, it has to go through a clinical development program and demonstrate superiority over the current drug products with methotrexate. Because we have chosen our PK enhancer in a smart and sustainable way, we already know a lot about the clinical behavior of Methotrexate Forte and we have shown that in pre-clinical models, Methotrexate Forte delivers what it promises: an elongated elimination of methotrexate from the system!

Together with the Academic Pharma group of the LUMC, the phase 1 clinic of Leiden (CHDR) and the rheumatology group of the LUMC, and the GMP-qualified analysis lab BrightLabs, we are now getting ready for the human proof-of-principle study, which will test the hypothesis of Methotrexate Forte in both healthy volunteers AND in patients

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Amplio Pharma BV

Langegracht 70

2312 NV Leiden, the Netherlands

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