AstraZenecom Fasenra Phase 3 Clinical

AstraZeneca recently published high-level results from the open label 3b PONENTE study of the anti-inflammatory drug Fasenra to treat asthma. The data showed that Fasenra eliminated most patients from maintaining OCS in patients with oral corticosteroid (OCS)-dependent asthma with a wide range of blood-thymosinophil counts.Severe asthma is a often debilitating disease that affects about 34 million people worldwide. More than one-third of these patients are currently using chronic or intermittent OCS on the basis of other therapies to control their symptoms and acute exacerbation. However, frequent or long-term use of OCS can lead to serious adverse effects.PONENTE is a multi-center, open-label, single-arm, IIIb phase trial conducted in patients with severe eosinophil asthma who receive high doses of inhaled corticosteroids (ICS), long-acting beta-2 astrations (LABA), long-term use of OCS therapy, co-use or unlinked with additional asthma control drugs, with the aim of assessing the effectiveness and safety of daily OCS use after initiating Fasenra 30mg subsurfacial injection (SC).
showed that 62% of patients at the first major endpoint completely eliminated daily use of OCS. In the second major endpoint, 81% of patients achieved complete elimination, or were able to reduce their daily OCS dose to 5 mg or less when further reductions were due to adrenal insemusity. Both major endpoints last at least 4 weeks while maintaining asthma control. PONENTE includes nearly 600 patients in Europe, North America, South America and Taiwan.
by reducing the use of high-dose OCS by adopting faster steroid reduction programs in patients without adrenal insanity, the PONENTE trial expanded the data previously found in the ZONDA Phase 3 trial to reduce OCS use. The PONENTE trial also had a longer duration of about 24-32 weeks, and the PONENTE trial showed a more lasting OCS reduction and asthma control than ZONDA and all other published biologic drug trials. In the PONENTE trial, Fasenra's safety and tolerance were consistent with known drug characteristics. The results of the trial will be presented at an upcoming medical conference.Professor Andrew Menzies Gow, head of lung medicine at the Royal Brompton Hospital in London and lead investigator on the PONENTE trial, said: "These exciting results demonstrate Fasenra's role in eliminating or reducing oral corticosteroids (OCS). The reduction achieved by the personalized OCS reduction program is particularly important because adrenal insemuction can be an obstacle to safe and meaningful OCS reduction. These data will provide information on guidelines for the treatment of severe asthma and increase doctors' confidence to more safely eliminate long-term OCS in patients.
Pangalos, executive vice president of biopharmaceutical research and development at AstraZenecon, said: "Currently, 13.5 million people with severe asthma worldwide rely on oral corticosteroids (OCS) to control their deterioration and prevent hospitalization. However, over-reliance on OCS can also pose serious health risks and put additional pressure on the health system. These data further support The clinical profile of Fasenra's elimination of OCS in a wider group of severe asthma patients.Fasenra's active pharmaceutical ingredient is benralizumab, a monoclonal antibody that binds directly to the leukocyte interleukin 5 receptor α subkey (IL-5R alpha) on acidic granulocytes and uniquely attracts natural killer cells (NK cells) to induce the rapid and almost complete depletion of eosinophils through apoptosis (procedural cell death).
, Fasenra has been approved in the United States, the European Union, Japan and other countries and regions as an additional maintenance therapy for the treatment of severe eosinophil asthma. In addition, the Fasenra self-medication option has been approved by the United States and the European Union for self-administration by patients with a new pre-filled, disposable auto-injector (Fasenra pen), or Fasenra injection pen.Fasenra was licensed by AstraZeneta from BioWa, a wholly owned subsidiary of Kyowa Hakko Kirin, a Japanese pharmaceutical company. At the end of March this year, AstraZeneta signed a new agreement with Concorde Kirin to grant Fasenra full Asian rights. In addition to approved eosinophilic asthma adaptations, AstraZeneone is evaluating Fasenra's treatment of eight acidic granulocytic-driven diseases, including severe nasal polyps, esophageal esophagitis (EoE), high eosinophil syndrome (HES), eosinophilic granulitis (EGPA), chronic obstructive pulmonary disease (COPD), etc. Previously, the FDA had granted Fasenra the status of orphan drugs for the treatment of EoE, HES, and EGPA. (Bio Valley)original source: Fasenra eliminated oral corticosteroid use in a majority of of the OCS-dependent patients with asthma in PONENTE Phase IIIb trial