Our client, a mid-size Biotechnology Company based in Europe was entering a crowded market with a new asset. It was critical for the Company to find a way to compete with the first and second line of treatments through improved efficacy data.
It is known that the sub-optimal choice of imaging biomarkers and protocols lead to higher costs and delays. However, for our client a clear strategy for optimized efficacy end points led to an early M&A deal.
Prior to the study start, IAG’s Strategy team and Clinical Advisory Board conducted in-depth market analysis to understand the range of efficacy endpoints achieved in phase II and phase III trials in this therapeutic area by the competing companies.
Given that in this therapeutic area, a lot of the patients are already being treated and are often on the alternative medications, it was also critical to determine just the right number of patients needed to ensure statistical significance of the primary and secondary end points vs. the timeline and budget of the study.
IAG’s team has advised the Company on the optimized design of the trial, which involved 350 patients at 50 sites, with a sub-study involving advanced imaging biomarkers and associated scoring methodologies. The sub-study was needed to give better understanding of the treatment efficacy and investigate the possibility of its positioning as the first line (initial) treatment for these patients.
The partner CRO company was able to engage the sites in the right geographies to ensure speedy enrolment of the right patient cohort.
In this study, we were able to see statistical significance of the treatment at month 3 (with the industry standard being month – 6 or later), which of course was a remarkable improvement to the existing efficacy data.
At the time of writing, the Company has competed negotiations and sold this asset to a large pharmaceutical player. The Company is focusing now on validating their clinical platform in other therapeutic indications.
IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com