Case Studies Archive - Alacrita

Assessing a Phase 3b follow-up trial for pharma licensing opportunity

Written by Cort | Aug 6, 2024 2:40:41 PM

Challenge:

Our client, a PE-backed specialty pharma company growing rapidly through M&A, was assessing a number of late-stage development projects to license/acquire. The asset in question was a small molecule targeted against an acute but severe CNS indication that had completed Phase 3a with data insufficient for licensure. The target company had developed a plan for a follow-up trial (Phase 3b, and our client asked us to assess those plans in the light of the data accumulated to date.

Solution:

One of Alacrita's most senior pharmaceutical neurologists, who had had direct experience of treating the indication while in clinical practice early in his career, reviewed the data presented by the developer. The most useful part of the analysis was an online Q&A session with the target company's CMO who provided extraordinary detail about the results of the preceding trials and an in-depth analysis that supported the design of the Phase 3b trial. Our neurologist concluded that the plans were sensible and that risks were manageable despite the high level of clinical uncertainties associated with all similar CNS indications.



In-Licensing and Asset Scouting

Alacrita supports both large pharma and biotech companies with their search and evaluation activities. Our scouting support is often structured to integrate with the client’s internal efforts, resulting in a consistent flow of new, qualified opportunities. 

We also provide due diligence and valuations to help clients evaluate pharma and biotech assets for licensing or acquisition.