Verona’s Ohtuvayre shows promise in the treatment and management of Chronic Obstructive Pulmonary Disease

1. Ohtuvayre showed significant improvement in lung function by 12 weeks.
2. Follow-up analyses showed that Ohtuvayre had long-term benefits by reducing the rate of exacerbations over a 24-week period.

The Latest

In two Phase 3 trials, Ohtuvayre has shown promising results in improving lung function in Chronic obstructive pulmonary disease (COPD) patients and improving quality of life. Known as ENHANCE-1 and ENHANCE-2, the clinical trials aimed to examine the FEV₁ in patients following 12 weeks of treatment compared to placebo. FEV₁ is a measure of the amount of air a person can forcefully exhale in once second and is a key indicator of lung function with higher numbers correlating with better breathing ability and reduced COPD symptoms. In the ENHANCE-1 study, patients given Ohtuvayre showed an average FEV1 increase of 61 mL, whereas the placebo arm experienced a 26 mL decrease. In ENHANCE-2, Ohtuvayre recipients gained 48 mL in FEV1 on average, in contrast to a 46 mL reduction for those on placebo. The follow up analysis of ENHANCE-1 and ENHANCE-2 trials found that Ohtuvayre reduced flare-ups through 24 weeks by 40% in patients with moderate to severe COPD.

Physician’s Perspective

According to the WHO, COPD is the fourth leading cause of death worldwide approximating 5% of all global deaths. Common symptoms of COPD are difficulty breathing, chronic cough, and fatigue. These symptoms can often become more severe known as flare ups and require additional medicine. COPD can lead to higher risk of other health conditions such as pneumonia, lung cancer and depression. Ohtuvayre is unique as it is the first drug to work both as a non-steroidal anti-inflammatory agent and a bronchodilator. Steroids presently remain a benchmark in treatment of COPD exacerbations. Ohtuvayre now presents another option for physicians without the risk of steroid-based COPD medications such as oral thrush and infections.

Molecular Target of Therapy

COPD is a progressive lung disorder characterized by chronic inflammation in the airways, alveolar damage, and airflow limitation. At the molecular level of COPD, a phosphodiesterase (PDE) is a family of enzymes that breakdown important signalling markers such as cyclic AMP (cAMP). The breakdown of cyclic AMP leads to enhanced inflammatory signalling and reduced bronchodilation signals leading the chronic inflammation and airway constriction seen in COPD patients. Ohtuvayre inhibits two types of phosphodiesterase known as PDE3 and PDE4. By preventing the breakdown of PDE3, this promotes bronchodilation to help open the airways and allow airflow. By preventing the breakdown of PDE4, this reduces inflammation to ultimately prevent the frequency of flare-ups.

Company History

Verona Pharma is UK based pharmaceutical company that has a development pipeline focused on the treatment for respiratory diseases, including COPD, asthma, and cystic fibrosis. Verona Pharma has multiple phase 2 trials underway for Ohtuvayre in different formulations including MDIs and nebulizers to treat Asthma and COPD. The current ongoing studies will also examine dosing regiments and adjunctive therapies in current standard of care respiratory diseases.

Additional Reading: https://www.atsjournals.org/doi/full/10.1164/rccm.202306-0944OC