Situation analysis

A start-up pharmaceutical company active in the anti-HIV area wanted to develop a fixed dose combination (FDC) of two already marketed compounds, one antiviral agent and one non-antiviral agent. By taking advantage of the synergistic interaction between the two agents the company aimed to explore even lower dose levels than the marketed dose levels to allow for lower toxicity but similar or even better anti-viral efficacy. For one of the agents in the FDC it was desirable to modify the release profile and thereby the plasma concentration-time profile to reduce the toxicity, while maintaining the same plasma concentration-time profile of the other agent.

How did we handle it?

Kinesis wrote a drug development plan including the projected costs and timelines of the project. An integrated development team was formed from the experienced internal Kinesis staff and the sponsor, covering all essential functional areas for the project.

What was the outcome or benefit for the client?

Kinesis selected 2 out of 5 protype modified release formulations from a preclinical model. These protypes were the basis for two different FDC formulations that were tested and compared with the individual market formulations of the two agents in a Phase I bioavailability trial. Based on this trial the most optimal FDC formulation was selected for use in a Phase IIa dose finding study in which different combinations of the antiviral and one non-antiviral agent were tested in patients with HIV. During the course of the study the company build up their own staff and was able to coordinate the project without the help of Kinesis. Kinesis is still involved in building a population PK/PD model to identify the most optimal dosing scheme to combine both agents. Kinesis presented the company with a low-risk, and highly flexible staffing approach with no need to invest significant time and money in staff recruitment and staff training. This allowed the company to start immediately after the kick-off of the project, while the decision to recruit additional personnel could be postponed to a point of sufficient evidence of proof-of-concept.