Biologics seek to expand indications…is approved for COPD

in addition to atopic dermatitis and asthma

Dupixent receives approval for COPD in the U.S.

Other biological agents such as Nucala, Fasenra, Tezspire continue clinical trials

Biological agents are expanding their reach beyond inflammatory diseases such as atopic dermatitis, oesophagitis, and asthma to lung disease.

 

Recently, Sanofi and Regeneron's biologic Dupixent was approved by the US Food and Drug Administration (FDA) for the treatment of chronic obstructive pulmonary disease (COPD).

 

Other biologics, such as GSK's Nucala and AstraZeneca's Fasenra, have also shown progress in treating COPD in clinical trials and are looking to expand their indications.

 

Biologics are manufactured from pathogenic microorganisms, such as proteins, antibodies, nucleotides, and cells.

 

They have specific effects on specific proteins or cells, which enables them to treat diseases, and are characterized by low side effects compared to chemical drugs.

 

Dupixent secures first COPD indication among biologics

Sanofi and Regeneron

According to industry sources on the 3rd, the FDA approved Dupixent for the treatment of COPD.

 

This is the first COPD indication secured by a biologic.  Dupixent is the first biologic to target the signaling of interleukin (IL)-4 and IL-13, which are key drivers of type 2 inflammation.

 

It has been shown to be effective in inflammatory conditions such as asthma, atopic dermatitis, and eosinophilic esophagitis.

 

The expansion of Dupixent’s indication to COPD was based on the Phase III BOREAS and NOTUS trials.

 

The trials included 1,874 COPD patients.

 

Patients were randomly assigned to receive Dupixent or placebo every 2 weeks in addition to triple therapy with an inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and long-acting muscarinic antagonist (LAMA) or dual LABA and LAMA dual therapy.

 

Results showed that Dupixent reduced the annualized rate of moderate or severe COPD exacerbations by up to 34% compared to placebo over 52 weeks, which was the primary endpoint.

 

In addition to Dupixent, Sanofi, and Regeneron are developing the IL-33 inhibitor itepekimab for COPD.

 

The companies are currently conducting 2 clinical studies on itepekimab and expect to present new data next year.

 

Biologics continue to look to expand COPD indications

GSK

In addition to Dupixent, other biologics are also looking to expand their indications to COPD.

 

GSK recently announced positive clinical trial results for its IL-5 inhibiting biologic, Nucala.

 

The trial was conducted in 806 COPD patients aged 40 years and older without asthma who required triple therapy with an ICS, LABA, or LAMA to determine the efficacy of Nucala in moderate/severe exacerbations.

 

Results showed that Nucala reduced the primary endpoint of moderate/severe annualized exacerbation rate.

 

Patients treated with Nucala for up to 104 weeks demonstrated a statistically and clinically significant reduction in the annualized exacerbation rate compared to placebo.

 

AstraZeneca is investigating the biologic Fasenra for several diseases, including COPD, chronic rhinosinusitis, and hypereosinophilic syndrome (HES).

 

Fasera is a biologic that binds directly to the IL-5 receptor alpha on eosinophils, leading to rapid depletion of blood and tissue eosinophils.

 

AstraZeneca

However, Fasenra did not demonstrate an effect in COPD in 2 clinical studies - GALATHEA and TERRANOVA, which were published in 2019.

 

AstraZeneca is conducting a third Phase III study on Fasenra in patients with high eosinophil levels, as it has confirmed the drug’s benefit in this population.

 

The ongoing Phase III RESOLUTE trial, which is studying Fasenra in more than 600 COPD patients, is expected to be completed by next June.

 

AstraZeneca is also seeking to expand the indication for Tezspire, a biologic the company had co-developed with Amgen, to COPD as well.

 

Tezspire is an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody therapy that binds to TSLP, which causes airway inflammation.

 

Other biologics inhibit IL-5, lgE, and others, and Tezspire is the first to target this mechanism.

 

Currently, Tezspire is only approved for the treatment of severe asthma.