Pre-Due Diligence Assessment of First-in-Class Allergy Therapeutic

Challenge:

A pharmaceutical company seeking new assets requested a pre-due diligence assessment of a European biotech developing a first-in-class compound for treating allergic conditions. The biotech had assembled significant supporting science, a robust IND-enabling package, and early clinical data.

The client needed expert evaluation to determine whether to proceed to full due diligence, particularly given that early efficacy readouts were somewhat modest despite the strong scientific foundation. Key questions included:

• How to interpret the disconnect between robust preclinical data and modest clinical signals
• Whether the current data package justified partnership investment
• What additional development would be required for proof-of-concept
• Risk assessment of a first-in-class mechanism in the competitive allergy market

Solution:

Our consultant, a former Chief Medical Officer with experience in the allergy field, assessed the preclinical and clinical data. The assessment focused on:

Preclinical Package Review: As anticipated based on the development team's credentials and track record, studies had been conducted to an impressive depth and breadth. The mechanistic studies, disease models, and safety pharmacology data exceeded typical standards for this development stage.

Clinical Data Analysis: The early clinical data showed somewhat uninspiring efficacy readouts. Our analysis examined potential reasons for these modest results and evaluated whether they reflected fundamental issues with the mechanism or study design considerations.

Development Path Assessment: We evaluated requirements for definitive proof-of-concept, including optimal trial design, patient selection strategies, and dose optimization approaches.

Outcome

The weight of scientific data, both preclinical and translational, offset the somewhat uninspiring early efficacy readouts. We concluded that a single, relatively modest Phase 2b trial could provide definitive go/no-go data for this potentially breakthrough therapy.

Our key findings:

• The quality and completeness of the preclinical package provided strong confidence in the mechanism
• Early clinical results were consistent with conservative study design rather than lack of efficacy
• A well-designed Phase 2b study could definitively establish proof-of-concept within reasonable timelines and budget
• The first-in-class mechanism offered significant upside if efficacy could be demonstrated

Based on our assessment, the client proceeded to full due diligence negotiations with a clear understanding of the development risks and pathway forward.

Pre-Due Diligence Assessment Services:

Alacrita helps pharmaceutical and biotech companies evaluate external partnership opportunities through rigorous pre-due diligence assessments. Our experienced consultants with deep therapeutic area expertise systematically evaluate scientific rationale, development risks, competitive positioning, and commercial potential. Whether assessing first-in-class mechanisms, early-stage assets, or complex development programs, we provide evidence-based analysis to inform partnering and licensing decisions and optimize deal structures.