Challenge:
A private biotech company with first in class, early lead compounds targeting a novel metabolic signaling protein engaged Alacrita’s NASH consultant to explore the best disease pathways for development. One potential disease target was non-alcoholic steatohepatitis (NASH) which is a large potential commercial opportunity. However, the company was concerned about the existing competition, and the expense and time required to compile the studies necessary for submission of an IND. Alacrita was engaged to evaluate competition in the space, required IND-enabling studies, and provide strategic advice on pursuing NASH as an indication for their novel target and compounds.
Solution
Utilizing internal staff and its expert pharma network, Alacrita approached the project by systematically assessing each component of the challenge to provide an overall opinion on the desirability to pursue NASH with the novel asset. The opportunity for an impact of the company’s drug was evaluated by comparing the mechanism of action based on early pre-clinical experiments with other NCEs in pre-clinical and clinical development at the time. Next, the portfolio of pre-clinical studies that would be required to demonstrate a potential NASH disease effect and to file an IND was assessed. This included a review of all the available NASH pre-clinical models, the pros and cons of each model, and a recommendation for which model would be most efficient and useful for testing the company compound. Finally, the approximate cost and time to an IND was estimated. These paths of analysis were integrated into a strategic recommendation, including the likely interest of large Pharma in the asset at the end of the recommended pre-clinical work, that could be used by the company for ultimate decision making on the direction of the program.
More Information:
Project Lead: Peter Traber
Key Services: Product Development, Clinical Development Support
For more information on this Alacrita service please email ptraber@alacrita.com