Pfizer, HemoShear to Create New Drug Safety Paradigm

HemoShear Therapeutics has partnered with Pfizer to develop a predictive model for preclinical drug-induced vascular injury (DIVI). Financial terms of the multi-year deal were not disclosed.

The initial stage of the collaboration was designed to assess the repeatability of vascular toxicities of a specifically chosen set of drugs in HemoShear’s REVEAL-Tx platform. In this next stage, the companies will use HemoShear’s platform to assess a large number of compounds with the aim of building a predictive computational model that would be used for evaluation of vascular safety of Pfizer drug compounds before entering pre-clinical stages of development.

“Drug toxicity discovered in pre-clinical or clinical trials has serious implications for drug development,” said Jim Powers, chief executive officer, HemoShear. “Our collaboration has the potential to create a new safety paradigm for the pharmaceutical industry that improves confidence in selecting safer drug candidates for pre-clinical trials, and we look forward to working with Pfizer to further develop this much needed, predictive model.”

DIVI poses a safety dilemma for the pharmaceutical industry because of limitations in resolving the underlying drivers of vascular injury. In addition, there are no generally accepted diagnostic or predictive biomarkers to understand when or why DIVI will occur, nor are there models to select the safest compound prior to animal testing. If drug toxicity occurs in an animal, significant program delays and additional costs are incurred to investigate and explain the underlying biology and determine whether the compound is safe to move forward to human testing, or to determine if another compound would be safer.  In some cases, decisions are made to stop a program altogether in the absence of a clear understanding of the injury and whether an animal response translates to human clinical outcomes.

In addition to leveraging REVEAL-Tx for safety and drug discovery collaborations with pharmaceutical companies, HemoShear Therapeutics is pursuing its own drug discovery programs in metabolic diseases with high unmet need.