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), COVID-19, 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 has started the ENHANCE Phase 3 clinical trials.
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 commercialization rights to ensifentrine.
Nebulized ensifentrine has started Phase 3 clinical trials as a maintenance treatment for moderate to severe 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 projected to rise to about $50 billion in 2020. We believe ensifentrine will have an important role as an add-on therapy for dual/triple treated patients.
In addition to nebulized ensifentrine, we have developed dry powder inhaler (DPI) and pressurized metered dose inhaler (pMDI) formulations of ensifentrine for less severe patients. Initial results from Phase 2 trials for the maintenance treatment of COPD are promising. In the US, DPI and pMDI handheld inhalers are the most widely used option for medication in COPD, with an estimated 5.5 million people using them for COPD maintenance therapy. This market was valued at approximately $10 billion in 2019.
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 are developing ensifentrine for the treatment of COVID-19 and may also develop it for cystic fibrosis and severe asthma. CF is considered an orphan disease by both the US and European regulatory authorities. According to WHO estimates, 300 million people suffer from asthma and it is the most common chronic disease amongst children.
Initially, we are developing ensifentrine for the US and European markets. However, we may also develop ensifentrine for other markets such as China, which has more than 50 million COPD patients and is estimated to grow to 70 million in 2030.
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 first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4) that acts as both a bronchodilator and an anti-inflammatory agent in a single compound.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.