Challenge:
A Chinese biotech company was evaluating a potential in-license product, a first-in-class agent for the treatment of ataxia and tremors in patients with Spinocerebellar Ataxia (SCA). The client requested Alacrita support in conducting a due diligence review of the preclinical safety and toxicology profile, existing Phase 1 and 2 clinical and regulatory data, and the CMC package.
Solution:
The project comprised a detailed review of all relevant documents and materials describing the asset including:
- Reports and publications about the pharmacology of the molecule
- Toxicology and preclinical study reports
- Documentation relating clinical and regulatory development data and protocols
- Documentation relating to CMC or manufacturing strategy and data
- Any market or competitive analysis
Alacrita determined the nature and level of risks associated with the program and analyzed future development plans and timelines along with recommendations for any changes (CMC, clinical, regulatory etc.). Finally, we conducted an assessment of the competitive landscape as it relates to the indications under development as well as the class of molecule/mechanism of action.
We concluded that there were concerns regarding biodistribution, narrow therapeutic window, teratogenicity, granulation manufacturing, a potentially lengthy phase 2 study and the possibility of safety issues. None of these issues were judged insurmountable but the investment needed to secure registration would be very high.
Due Diligence Services
Alacrita's due diligence experts have conducted over 200 major assignments for large pharma, biotech, universities and investors, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise expertise required for a complete, thorough and accurate assessment.
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