The three limbs of Reponex’s strategy
Reponex intends to meet this need in a cost-effective, low-risk manner by combining effective drug- development strategies, repositioning and rerouting, and in some cases with recombining of different drugs that can act synergistically to treat different aspects of the disease process in parallel, to achieve a potent therapeutic effect.
This means essentially finding a new use for an established drug. Characteristically, this entails using the drug for a different indication (i.e. for treating another disease) than it was initially developed for, with the advantage of opening up a new market while saving on the preclinical and clinical phase I developing costs. Simple rerouting of this type has become a standard strategy employed by established pharmaceutical companies to extend their pipeline.
This means changing the route of administering the drug to a new one that is appropriate for the new indication. Essentially it means that Reponex reformulates the active pharmaceutical ingredients to make them suitable for local administration to the site where it needs to act, avoiding conventional systemic administration e.g. by intravenous or subcutaneous injection. This dramatically improves the efficacy of the drug, which reaches its site of action at high concentration, while correspondingly reducing or eliminating any systemic adverse reactions to drugs that penetrate poorly or not at all from the site of action to the systemic circulation.
This means combining different drugs that act on different aspects of the disease pathology to achieve an additive or even synergistic effect. At the same time, it is convenient for both the patient and the clinician not to have to apply several different medications at once to treat a single condition, but to use the preparation that has been developed to provide the best generally applicable combination. This principle is particularly well known in the drug combinations used to treat high blood pressure.
These three value creators apply generally to the products in Reponex’s pipeline, the only exception being when a single active ingredient is sufficiently effective by itself so that any combination becomes optional.
This strategy confers a notable risk reduction in the process of clinical development: the basic properties and systemic side effects of the drugs are known; the reduction in systemic side effects by local administration is evident or has been reported in certain aspects; and at least preliminary evidence of the efficacy of the active ingredients has been obtained e.g. when they been given individually by conventional routes. These factors enable several years, and substantial risks and costs, to be removed from the pathway to the market and thus both shorten and increase the chance of success of the clinical development. They will be expounded in further detail below.