AstraZeneca and Amgen rolled out Phase IIb data on their late-stage drug tezepelumab late on Wednesday, spotlighting some dramatic results for a therapy they believe could have megablockbuster potential for the broad-based treatment of uncontrolled asthma.
Bottom line: Treatment-resistant patients in the drug arm taking a medley of doses saw their annual exacerbation rate slashed anywhere from 61% to 71%.
Developed at AstraZeneca and bound for a commercial partnership, researchers say the drug was effective because it targets TSLP, an epithelial cytokine stoked by lung pathogens such as allergens and viruses. TSLP in turn triggers a rampage of inflammatory cytokines such as IL-4, IL-5 and IL-13.
By moving upstream from those targets, the pharma giants believe that they may be on to a breakthrough approach that can leap the more singularly-targeted rivals coming into the market, seizing billions in new revenue.
“This broad biomarker response is unprecedented among respiratory biologics and reflects our commitment to leading respiratory science for unmet medical needs,” says Bahija Jallal, who runs AstraZeneca’s big subsidiary MedImmune, where the research work is being done.
That broad-based approach could have a big impact on other injectable respiratory drugs such as GSK’s Nucala, Teva’s Cinqair as well as AstraZeneca’s own benralizumab — which it doesn’t share with Amgen — and Dupixent from Regeneron and Sanofi. Benralizumab is currently under review and is given a good shot at an approval.
Leerink’s Seamus Fernandez was excited by the data. So excited that he believes these partners have a shot at grabbing an accelerated approval on the Phase IIb data while launching Phase III as a confirmatory study — an approach that could start delivering up to $4.5 billion a year in revenue within 4-5 years.
Based on the strength of these data, we believe this trial may qualify as a registrational study (with the need for a confirmatory Phase III trial for approval), similar to the approach that SNY/REGN are taking with Dupixent. However, this may be dependent on whether the FDA will want to see additional dose ranging studies to address questions regarding safety and the lack of a clear efficacy dose response.
Dupixent, of course, has already been racking up revenue with an established safety profile, making a quick, added OK much easier for regulators. In this case, regulators are much more likely to raise some barbed questions about concerns this drug has spurred about its impact on the immune system. That issue was touched on by Elisabeth Bel of Amsterdam’s Academic Medical Center, who wrote a piece in the NEJM noting the need for safety studies that could carefully examine the interplay between drug and immune system.
Nevertheless, AstraZeneca and Amgen now have a late-stage drug they can tout as a potential blockbuster in an intensely competitive field — exactly what the biotech ordered for these companies as they work to build new revenue with game changing therapies.
That’s a definite plus.
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