Boost for Verona Pharma after trial win with inhaled COPD drug
UK-based Verona Pharma has scored a new win with its chronic obstructive pulmonary disease (COPD) drug ensifenitrine, after a formulation delivered with an inhaler met its goals in a phase 2 trial.
The company has been making slow but steady progress with ensifentrine and finally began to make a case for the potential first-in-class drug in a nebulised formulation , which is in phase 3 development as a maintenance therapy in COPD.
These results come from the pressurised metered dose inhaler (pMDI) formulation, which the company said met all endpoints in a seven-day phase 2 clinical trial.
Results showed a highly statistically significant and clinically meaningful increase in lung function as measured by peak forced expiratory volume in one second (FEV1) measured over four hours post-dose, compared with placebo after seven days of treatment.
Secondary lung function endpoints were met and support twice daily dosing, with statistically significant improvements in average FEV1 over 12 hours corrected for placebo.
There were also statistically significant improvements in both morning trough FEV1 and on average over four hours.
Ensifentrine pMDI formulation was well tolerated at each dose with an adverse event profile similar to placebo.
While the results seem to be impressive Verona is still without a partner to develop the drug, although shares increase by more than 13% in premarket trading on the Nasdaq following the announcement.
There could be concerns about the long term marketability of the drug as its original composition patent expired last year.
This would leave Verona relying on other patents to protect the drug from generic competition, although this could be possible for a company with a strong legal team in place.
The drug has also had success in combination with Boehringer Ingelheim’s Spiriva in a phase 2 COPD trial last year, adding another potential string to its bow.
Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4).
This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound.
It could also be used as a treatment for cystic fibrosis and relieving inflammation caused by viruses.
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