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New genetic approach could reduce risk of late-stage drug failures – Pharmaceutical Technology

by JMC on June 8, 2016

The University of Cambridge and UK-based pharmaceutical company GlaxoSmithKline (GSK) have collaborated to demonstrate a new genetic approach capable of reducing the chances of drugs failing during the later stages of clinical trials.

The new approach helps identify genetic variants that replicate the action of a drug on its intended target and then assessing in large patient cohorts if these variants cause the risk of other conditions, such as cardiovascular disease.

GSK joint senior author Dr Dawn Waterworth said: “By pooling our resources and expertise in collaborations like this one with Cambridge University, we believe there’s an opportunity to expand our knowledge of disease biology, which in turn could help reduce the risk of late-stage failures and accelerate the development of innovative new treatments for patients.”

While developing a new drug, pharmaceutical companies have to not only demonstrate its effectiveness in treating a particular condition, but also confirm that the drug does not cause any adverse side-effects in patients.

The Food and Drug Administration approves the marketing of all new medicines in the US and has stated that any new anti-diabetic medicine needs to also confirm cardiovascular safety.

A major class of anti-diabetic therapies, known as glucose-lowering, glucagon-like peptide-I receptor (GLP1R)-agonists, binds to the GLP-I receptor in order to increase insulin production, thereby helping reduce blood sugar levels.

However, the cardiovascular safety of this class of agents, including the risk of heart disease, remains unknown.

“These findings suggest that beyond their effectiveness in treating diabetes, these drugs may have the added benefit of lowering risk of heart disease.”

While evaluating genetic variations in DNA encoding drug targets for type II diabetes and obesity, the researchers detected a variant in the GLP1R gene that was related to lower fasting glucose and a lower risk of type II diabetes.

Therefore, the variant appeared to mimic the action of the diabetes drugs.

The researchers used the genetic data available through an international data-sharing consortium to study the association of that same variant in patients with coronary heart disease, to discover that the variant actually helped reduce the risk of heart disease.

University of Cambridge MRC epidemiology unit director Nick Wareham said: “These findings suggest that beyond their effectiveness in treating diabetes, these drugs may have the added benefit of lowering risk of heart disease.”

Source: New genetic approach could reduce risk of late-stage drug failures – Pharmaceutical Technology

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