Tuesday brought good news for asthma sufferers and the healthcare community alike, courtesy of GSK. The pharmaceutical firm announced the successful reduction of annual asthma attacks in two pivotal clinical trials of its experimental antibody treatment named Depemokimab. The trials involved adults and adolescents afflicted with a form of severe asthma.
GSK’s newly developed long-lasting asthma drug, Depemokimab, has reportedly cleared two pivotal Phase 3 trials, as reported on Tuesday. The experimental antibody treatment has been shown to reduce the annual frequency of severe asthma attacks in adolescents and adults.
Depemokimab specifically targets interleukin-5 (IL-5), a primary component of the body’s immune response. IL-5 is also the target of GSK’s other approved asthma medication, Nucala, which attained a remarkable $2.1 billion in sales in 2023. The key differentiating factor is that, while Nucala requires a monthly dose, Depemokimab allows for six-month dosing intervals, providing a more convenient option for patients managing severe asthma.
Two Phase 3 trials of Depemokimab involved participants with severe type-2 inflammatory asthma, which is often identified by heightened levels of a specific white blood cell that promotes inflammation. The results of these trials, named SWIFT-1 and SWIFT-2, both demonstrated a decrease in the annual rate of asthma attacks, aligning the severity and frequency of adverse events to those of a placebo.
GSK, which currently rivals AstraZeneca’s asthma drug Fasenra on the market, has high hopes for Depemokimab. If the drug is officially approved, the company foresees a potential peak year sales of ~3.9 billion. GSK also has ongoing studies of Depemokimab in Nucala or Fasenra patients suffering from severe asthma in a third Phase trial dubbed NIMBLE.
GSK’s plans to seek regulatory approval in the US in the latter half of 2024, and in the EU, China, and Japan in 2025 are underway. The positive results from the SWIFT trials will be analyzed further and will be presented at a future scientific congress, aimed to support worldwide health authority submissions for Depemokimab.
Unveiling the Underlying Mechanism: Depemokimab
As it stands, no regulatory body across the globe has yet approved Depemokimab. Patient convenience, potential for market dominance, and most importantly, the promise of improved health outcomes for individuals combatting severe asthma heighten the anticipation surrounding its potential approval. As GSK continues to make strides in the respiratory field, their commitment to finding better, more sustainable treatments for those living with severe asthma is evident. With Depemokimab’s notable performance in clinical trials and its potential for longer dosing intervals, it marks a significant step forward in transforming the lives of individuals suffering from this chronic condition.
GSK’s success with Depemokimab highlights the importance of continued research and development in the field of respiratory diseases. With ongoing studies and promising results, Depemokimab has the potential to improve the lives of millions of individuals suffering from severe asthma.
In addition to its efficacy in reducing annual asthma attacks, Depemokimab also shows promise for addressing type 2 inflammation, a significant factor in severe asthma cases. By targeting interleukin-5, Depemokimab has the ability to inhibit this pathway and potentially provide sustained relief for patients.
Moreover, Depemokimab’s potential for longer dosing intervals of six months could greatly benefit those managing multiple therapies for their condition. This not only reduces the burden on patients, but also aligns with physicians’ belief that longer dosing intervals would be beneficial for their patients.
The Regulatory Approval Journey
Keeping its eye on the prize, GSK intends to seek regulatory approval in the US by the second half of 2024, and then shift focus towards the EU, China, and Japan in 2025, as communicated to Endpoints News.
Two Successful Phase 3 Trials: SWIFT-1 & SWIFT-2
The Stage 3 trials of Depemokimab, named SWIFT-1 and SWIFT-2, welcomed participants with severe asthma accompanied by type 2 inflammation. This inflammation is usually linked with raised counts of a particular white blood cell that promotes inflammation. Both trials witnessed Depemokimab successfully lowering the annual rate of asthma attacks, with adverse events post-treatment mirroring the placebo.
The results of these trials suggest a brighter future for those living with severe asthma, as the medical world continues to make strides in finding longer-lasting, more effective treatments.
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