Our research and development activities are organized in programs corresponding to a drug candidate or family of drug candidates targeting a given cell receptor. Successive phases are distinguished in carrying out a program, defined in reference to milestones M0 to M3.

The milestone following milestone M3 is the first marketing authorization.
 

Before M0: this is the “exploratory research” phase when there is no defined program but a set of possible projects identified in-house or through an external opportunity. The objectives are to build a scientific rationale for pharmacological intervention on a molecular or cell target in a group of indications and to create or consolidate intellectual property elements.

Between M0 and M1: the program is in the “feasibility/validation” research phase. This phase aims to characterize a drug candidate and demonstrate its efficacy through pre-clinical studies in cellular or in vivo models.
A program number with two figures is attributed when milestone M0 is reached, and drug candidates belonging to this program are then referred to as IPH[program number].When a drug candidate is characterized, we change the product designation by attributing an order number to each drug candidate (e.g., IPH 21 corresponds to a set of pre-M1 drug candidates and IPH 2101 to a characterized drug candidate against this target).

Between M1 and M2: the program is in the “pre-clinical development” phase. For pharmaceutical development aspects, this notably consists in implementing a production method, producing pilot industrial batches, defining temporary product specifications and setting up analytical controls. Concurrently, non-clinical studies are carried out in pharmacology, toxicology and pharmacokinetics as required for the file presented to the regulatory agencies for the start of clinical trials. The first administration to humans, which is milestone M2, is subject to authorization by the competent regulatory authorities.

Between M2 and M3: the program is in the “clinical development for proof of concept” phase. Milestone M3 corresponds to the end of one or more Phase IIa studies. A summary of results is generally submitted to the regulatory authorities at the end of Phase II.

After reaching milestone M3, a decision will be made whether to continue development with large scale studies aimed at obtaining marketing authorization (Phase IIb and Phase III). We weigh the important decision to continue these studies with our own resources or through a partnership, sharing costs by sharing the commercial rights if the program is successful.