Our first-in-class development candidate, ensifentrine (RPL554), has the potential to provide relief for patients suffering from respiratory conditions such as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and asthma.
Ensifentrine is an inhaled therapy that acts as both a bronchodilator and an anti-inflammatory agent in one compound. This means, if approved, it would be the first single treatment that opens patients’ airways and reduces inflammation in the lungs.
Ensifentrine was evaluated in the Phase 3 ENHANCE clinical trials for maintenance treatment of COPD. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the third quarter of 2023, the US FDA accepted for review the Company’s NDA seeking approval of ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024.
We are focused on developing our product candidate, ensifentrine, which we believe has the potential to become an important and novel treatment for chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and other respiratory diseases, including asthma. We own the global development and commercialization rights to ensifentrine except in Greater China where we have formed a partnership with Nuance Pharma.
A New Drug Application has been submitted to the US FDA for nebulized ensifentrine for the maintenance treatment of COPD. Millions of COPD patients urgently need better treatments as they remain symptomatic despite maximum treatment with currently available therapies. In the US alone, total annual medical costs, indirect and direct, relating to COPD are about $50 billion. We believe ensifentrine will have an important role helping patients who remain symptomatic on existing treatments for COPD.
In addition to nebulizers, handheld inhalers are frequently used by COPD patients. We have developed dry powder inhaler (DPI) and pressurized metered dose inhaler (pMDI) formulations of ensifentrine. In Phase 2 clinical trials with these formulations, ensifentrine significantly improved lung function in COPD patients.
We may seek strategic collaborations with leading biopharmaceutical companies to develop and commercialize ensifentrine. These partnerships could provide significant funding to advance the development of ensifentrine while allowing us to benefit from the development and commercialization expertise of our collaborators.
We may develop ensifentrine for cystic fibrosis and severe asthma. CF is considered an orphan disease by both the US and European regulatory authorities. According to WHO estimates, more than 260 million people suffer from asthma and it is the most common chronic disease amongst children.
Initially, we are developing ensifentrine for the US market and seeking strategic partnerships in other regions. We have formed a $219 million strategic collaboration with Nuance Pharma to develop and commercialize ensifentrine in Greater China. The region has an estimated 100 million COPD patients.
We are leveraging our expertise in respiratory diseases to in-license or acquire additional clinical-stage product candidates. We are seeking assets with the potential to become novel treatments for respiratory diseases with significant unmet medical needs.
Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in over 10 years.Learn More
We are led by a globally experienced board of directors and a management team with an established track record in the discovery, clinical development and commercialization of respiratory therapies.
|Member||Audit and Risk Committee||Remuneration Committee||Nomination & Corporate Governance Committee|
Non-Executive Chairperson of the Board
President and Chief Executive Officer