91ºÚÁÏ

91ºÚÁÏ was approached via a website enquiry by a client seeking our expertise in conducting drug asset evaluation consulting services. The client, a well-established diagnostic company, aimed to establish a dedicated pharmaceutical research and development division; therefore, they looked to evaluate pharmaceuticals suitable for in-licensing or co-development, placing particular emphasis on autoimmune diseases. In this instance, the asset in question was a Phase 2, small molecule, being developed for an inflammatory indication. 91ºÚÁÏ were engaged by the client and provided a detailed technical review which included, non-clinical, CMC, clinical pharmacology, therapeutics and regulatory assessment. The diligence team outlined the key risks associated with the acquisition, along with suggested mitigation plans. On the basis of the diligence the client made the decision to proceed with the in-licensing which is on-going. 91ºÚÁÏ provided additional support by providing costing of the necessary clinical and non-clinical activities needed to
meet regulatory requirements.

The current owner of the asset is an Asia Pacific company who had limited experience in drug development in the indication in question and no experience in global drug development. Typical of many due diligence evaluations, the content of the data room was variable and needed supplementation with additional documentation and responses to diligence questions. The main areas of risk highlighted in the diligence were:

CMC

• Stability of drug substance and drug product
• Identification and control of impurities in drug substance
• Development of reliable and robust analytical methods

Clin Pharm

• Significant food effect identified resulting in 2-3-fold differences in exposure in fed compared to fasted state
• Identification of unknown major metabolites
• Difficulties in selection of dose to take forward into large scale clinical studies

After the diligence process concluded, the sponsor made the decision to proceed with licensing the asset. Subsequently, the sponsor approached 91ºÚÁÏ with requests for costing proposals (RFPs) for two distinct studies: a phase 2B study and an open-label extension.

When preparing the request for proposal (RFP), 91ºÚÁÏ were able to contribute significantly by incorporating the findings from due diligence. 91ºÚÁÏ provided the sponsor with a comprehensive list of recommendations, including the necessity for a definitive dose-finding study, accurate determination of pharmacokinetics with food effect and drug interaction studies, and various recommendations from a CMC perspective. Our diligence findings played a pivotal role in the sponsor¡¯s decision-making process, shaping the content of the RFP.

The sponsor sought additional consultancy from 91ºÚÁÏ. This led to a request for a relative bioavailability clinical pharmacology study following 91ºÚÁÏ¡¯s due diligence on this drug. Critiquing an existing protocol was part of this consultancy, and our clinical pharmacology group specialist provided recommendations for protocol modifications. Furthermore, the findings of diligence together with recommendations from consultancy enabled the client to negotiate with the sponsor for further development activities to be completed by the sponsor prior to licensing the asset. The RFPs encapsulated considerations for different development pathways, marking a comprehensive approach to addressing the identified challenges and optimising the development trajectory.