Providing due diligence for an Alzheimer’s treatment

Challenge

Our client, a major pension fund, was considering an investment in a Phase III neuroscience company, which was developing a small molecule to provide symptomatic relief of Alzheimer’s Disease (AD). Our client wanted to know the likelihood of clinical success in an ongoing Phase III clinical trial, therefore, one of our neuroscience consultants was selected to provide expert advice.

Our consultant had significant experience in neurology, psychiatry and molecular neurobiology, as well as 20 years’ experience in drug development from first-in-human studies through multiple Phase III clinical trials, across a range of CNS indications. Most recently, he had been Chief Medical Officer and SVP in Drug Development at a neuroscience company.

Solution

Our diligence team reviewed the contents of the data room, including investor presentation, investigator’s brochure, Phase III protocol and statistical analysis plan, Phase II clinical study reports, publications and regulatory correspondence. Our work focused on:

  •  assessing the appropriateness of clinical design, mitigation of adverse events and safety factors
  •  identifying the risk factors facing the AD clinical program
  •  determined completeness and appropriateness of regulatory response
  •  assessing the likelihood of clinical success and reviewing the overall development strategy

We completed the due diligence within two weeks and provided initial feedback to the client’s investment team. Upon receiving further clarification from the company, we provided a written report to the client, setting out the major risk factors. Finally, we held direct communication with the client’s team to explain our findings and answer any questions.

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