Chronic Airway Therapeutics (CAT), a proposed spin-off from Invion (ASX:IVX), says it has selected leading Chinese contract research organisation R&G Pharma Studies to support the development in China of nadolol as a treatment for chronic obstructive pulmonary disease (COPD).
R&G is one of China’s leading Contract Research Organisations (CROs).
CAT said it selected R&G because of the company’s demonstrated expertise, strong relationships with the China Food and Drug Administration (CFDA), and deep understanding of the similarities and differences with US FDA regulations.
CAT said it will work with R&G and focus their efforts towards lodging formal requests for a pre-IND and End of Phase 2 meeting with the CFDA during the fourth quarter of 2018.
The pre-IND meeting is a crucial step towards commencing Phase 3 clinical trials in China.
Nadolol, which unlike existing treatments can be administered in one single tablet per day, could play an integral role in diminishing the impact of COPD.
Dr Mitchell Glass, currently Invion’s chief medical officer, and to be appointed as CAT executive director, will lead CAT’s research and development program.
“This partnership with R&G provides increased confidence that our clinical studies will support approval in China and be widely accepted scientifically,” said Dr Glass.
COPD, which is a major health problem in China, describes various long-term lung diseases that cause shortness of breath. It includes emphysema and chronic bronchitis.
The prevalence of COPD in China is estimated to be above 50 million patients and rising due to the country’s serious air pollution and high rate of cigarette smoking. Chinese authorities have identified COPD as a critical area of medical need.
According to Dr Glass, “The risk of COPD and its complications - including chronic cough, increased sputum production, risk of hospitalisation and death - are all compounded by air pollution, which is a serious issue in China.”
Invion announced earlier in September 2018 that it would demerge its two respiratory assets, nadolol (INV102) and zafirlukast (IV104), into a separate company, Chronic Airway Therapeutics, subject to shareholder approval at the company’s General Meeting to be held on Tuesday 13 November 2018 in Melbourne.
Invion shareholders will be entitled to one CAT share for each Invion share they hold at the record date of Friday 16 November 2018. Investors who acquire shares Invion shares before the record date will be eligible to participate in CAT’s future development as a stand-alone company and its progress in the significant China market.