AstraZeneca said it will await results from a second Phase III trial assessing Fasenra™ (benralizumab) in chronic obstructive pulmonary disease (COPD) before deciding whether to continue developing the drug in that indication—after acknowledging that the respiratory drug has failed the first pivotal study.

Fasenra missed its primary endpoint in the GALATHEA Phase III trial (NCT02138916) of a statistically significant reduction of exacerbations in patients with COPD. AstraZeneca offered no details, except to say GALATHEA’s safety and tolerability findings for Fasenra in GALATHEA were consistent with those observed in previous trials.

AstraZeneca said a decision on further development of Fasenra in COPD will be made after the second Phase III study, dubbed TERRANOVA (NCT02155660), results from which are expected later this quarter.

The pharma giant added that a full evaluation of the data was ongoing and that results will be submitted for presentation at an unspecified “forthcoming medical meeting.”

“We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD,” Sean Bohen, M.D., Ph.D., EVP, global medicines development, and CMO, said in a statement.

Just three months ago on February 2, in releasing fourth-quarter and full-year 2017 results, AstraZeneca said it expected to file a regulatory submission next year seeking authorization to market Fasenra for COPD.

Both GALATHEA and TERRANOVA trials were randomized, double-blinded, 56-week placebo-controlled, multicenter trials designed to assess the safety and efficacy of Fasenra as an add-on to dual- or triple-inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.

GALATHEA evaluated two doses of Fasenra and enrolled 1656 patients; TERRANOVA, three doses and 2255 patients. The studies were both completed last month.

$2B Peak-Year Sales Forecast

While AstraZeneca projected as early as 2014 that Fasenra could generate as much as $2 billion in peak-year sales not adjusted for risk, that forecast was based on the drug being approved for numerous respiratory indications.

Fasenra is AstraZeneca’s first respiratory biologic approved and marketed in the U.S. as an add-on maintenance treatment of patients aged 12 years and older with severe asthma and with an eosinophilic phenotype.

The treatment is also indicated for severe eosinophilic asthma in the E.U., Japan, Canada, and Australia.

Fasenra is an interleukin-5 receptor subunit alpha–directed cytolytic monoclonal antibody designed to work by recruiting natural killer cells to induce rapid and near-complete depletion of eosinophils. Previous Phase I/II severe asthma trials showed an onset of action within 24 hours.

Fasenra was developed by AstraZeneca with MedImmune, the company’s global biologics research and development arm.

Last year, AstraZeneca agreed to pay Kyowa Hakko Kirin $15 million upfront, undisclosed payments for regulatory and commercial milestones, and low double-digit percent sales royalties—in return for exclusive rights to oversee development, sales, and marketing of Fasenra in severe asthma and COPD in 13 Asian countries and regions—except Japan, where AstraZeneca already held the commercialization rights to the drug after exercising in 2016 an option it was granted a year earlier.

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