CIC-tested biologic poised to become a “game-changing, blockbuster” asthma drug

In 2014, AllerGen’s Clinical Investigator Collaborative (CIC) conducted an early Phase II clinical trial on the injectable biologic drug tezepelumab, developed by MedImmune (the biologics arm of AstraZeneca) and Amgen, and first identified the drug’s significant therapeutic potential. “Now, it’s hitting the big time,” observes CIC Director Dr. Paul O’Byrne.

The CIC’s 2014 findings were published in The New England Journal of Medicine (NEJM), and reported broadly in major media outlets including The Wall Street Journal and Washington Post.

A follow-on Phase IIb trial of tezepelumab, conducted by Dr. Jonathan Corren of the University of California, Los Angeles, and colleagues, has now confirmed the CIC’s original evaluation and generated further expectations for an asthma treatment with “blockbuster potential.”

“Dramatic results” from this trial were published online in the NEJM on September 7, 2017, and presented at the European Respiratory Society (ERS) International Congress in Milan on September 12. In a commentary on the findings, also published in the NEJM, Dr. Elisabeth Bel describes the drug as “the broadest and most promising biologic for the treatment of persistent uncontrolled asthma to date,” positioning it as a strong contender in the multibillion-dollar market for severe asthma injections.

Tezepelumab is an antibody that blocks the action of thymic stromal lymphopoietin (TSLP), a protein involved in various allergic diseases including asthma. In this latest trial, the drug was shown to reduce asthma exacerbations in patients with moderate to severe, uncontrolled disease by between 61% and 71%, compared to placebo.

“This is the best example to date of what the CIC can do,” comments Dr. O’Byrne, who jointly led the 2014 trial with CIC Co-Director Dr. Gail Gauvreau.

“These results further validate the accuracy of the CIC’s allergen inhalation challenge model,” adds Dr. Gauvreau, “and its ability to identify early those compounds that merit continued development and those that are likely to fail in larger clinical trials.”

Since 2005, AllerGen’s allergic asthma CIC has completed or undertaken 21 clinical trials, attracting nearly $24 million in global pharmaceutical and biotechnology investments to Canada.

Dr. O’Byrne is Dean and Vice-President of the Faculty of Health Sciences at McMaster University and a world-renowned researcher and practicing respirologist.

Dr. Gauvreau is a Professor in the Division of Respirology of the Department of Medicine at McMaster University.