NovoBioJect, acts through the so-called PK enhancer technology, with the function to boost the clinical effectiveness of the treatment, and lead to superior treatment efficacy.

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In the 1990-ies, the so-called efflux proteins, or ABC-proteins were discovered. A scientific breakthrough - here was the mechanism behind the drug resistance that was hampering the efficacy of several treatments. In fact, in turned out that many drugs are substrates for efflux proteins, including those that are used to treat autoimmune diseases! Strikingly, only very few compounds are selective inhibitors of efflux proteins. It was only by chance that we discovered that we could block one of the efflux proteins involved in the elimination of the 1st line treatment of rheumatoid arthritis with NovoBioJect. The physical chemical properties of NovoBioJect are ideal: highly water-soluable and thus suitable for formulation as an autoinjector. Availability of historical human data and thus eligible for an abbreviated clinical development program at a far lower risk. 

 

All in all, Amplio Pharma is in the ideal situation to develop NovoBioJect

 

In the current clinical development program, the boosting effect of NovoBioJect on clinical efficacy and safety - compared to the standard-of-care, the 1st-line treatment with methotrexate (MTX) - is tested.

 

Background for selection of MTX to test the NovoBioJect superiority claim:

MTX is a small molecule that was first synthesized in 1948. In the 1980-ies Professors Joel Kremer and Michael Weinblatt demonstrated that MTX was an effective treatment of rheumatoid arthritis (RA).

Since then, MTX has become the Standard-of-Care (SoC) in the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs). 

Because of its original indication, many patients are worried when they are first prescribed MTX. However, in the dose range used to treat autoimmune diseases (5-30 mg per week) it is actually a very safe drug substance that is well-tolerated by the majority of the patients and can be taken chronically, by itself, or, most often, in combination with other so-called Disease Modifying Anti-Rheumatic Drugs (DMARDs).

The major draw-back with MTX is that it only works well by itself in some patients. In most patients, however, other drug substance(s) must be added to the MTX treatment regime before the disease goes into remission - this is true for many of the DMARDs, including the biological ones.

Such add-on treatments add costs, side-effects and time needed to disease remission!

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Researchers have tried to increase the efficacy of MTX treatments, either by changing the molecular structure of MTX itself, or by changing the formulation of the MTX drug product, or by linking MTX to "homing" molecules, so that more of the drug would enter the target tissues and cells. So far, none of these approaches has led to a significant improvement of the clinical efficacy of MTX.

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At Amplio Pharma, we have turned the effort to improve the Standard-of-Care treatment up-side-down and around. With NovoBioJect we present the promise of the future gold standard treatment of autoimmune disease.