Challenge:
An innovation fund interested in a research institute developing proprietary mAbs against a novel liver disease target, asked Alacrita to conduct due diligence on the development of this novel target. The institute had identified a novel chemokine pathway that mediates inflammation and fibrosis, and has developed proprietary antibodies to inhibit this pathway.
Solution:
We reviewed the scientific rationale, preclinical data, clinical work plan and budget for the program. We found that limited safety pharmacology variables were assessed in preclinical models, any proposal to conduct a Phase Ib in NAFLD and a Phase II in PSC within their suggested timelines was ambitious, and that more data needs to be collected on molecular profiling in patient groups prior to commencing the Phase Ib study. We also found that the clinical endpoints selected for the trials were appropriate, however additional secondary endpoints may be considered for Phase II and Phase III studies. Our recommendation to the innovation fund was that this project was worth an investment; a recommendation that was taken up.
Explore Our Due Diligence Services
Alacrita's due diligence consultants have been a trusted source of pharma and biotech DD for over 15 years, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise industry expertise required to be thorough, complete and accurate.
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