At the investigation stage of drug development, several tens of thousands of compounds are screened and after the most promising exploratory product is identified, safety and basic pharmacology are evaluated in non-clinical trials. Thereafter, the product is evaluated in Phase I on healthy subjects, and in Phase II and Phase III trials on patients. In the event that all studies show positive results, and the safety and efficacy is confirmed, the drug is approved. However, the probability that a compound will reach the market has in recent years been in the order of 1 in a 1,000 000, while the time necessary for the development is estimated to be 15 years with development costs more than $1 billion. At the same time, the number of drugs approved each year is decreasing.
In response to this challenging environment, Sosei have establish DRP®(Drug Reprofiling Platform®) a model that is directed towards a lower risk approach to development based upon identifying new uses for existing drugs and drug templates for which clinical development has been undertaken and the safety profile in humans confirmed. An example of this approach is the new indication for the Sosei pipeline product SD118 which has been identified in studies conducted under the Drug Reprofiling Platform.
Also, reprofiling of already marketed drugs is another low risk product discovery strategy. Usually, this is conducted as a part of life circle management by the product originator. However Sosei’s reprofiling strategy is based on focusing on compounds whose patent has expired, but whose safety had been confirmed. Based on this method, NVA237 (COPD) was reprofiled from an oral/injection drug to an inhaled therapy.
In recent years this concept has become an established paradigm, and is also called “repositioning” or “repurposing”. As a reduced risk method of drug development it has also become more widely used amongst the big pharma companies.
