- Chronic Airway Therapeutics (CAT) selects R&G Pharma to progress Chinese development of nadolol
- R&G is one of China’s leading Contract Research Organisations
- CAT, R&G ready to commence regulatory process and will request pre-IND meeting with China Food and Drug Administration
Melbourne, Australia and Delaware, United States, 27 September 2018: Chronic Airway Therapeutics (CAT), a proposed spin-off from Invion Limited (ASX: IVX, “Invion” or “Company”), has selected leading Chinese contract research organisation R&G Pharma Studies Co., Ltd 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) working closely with multiple Centres of Excellence located throughout China. CAT 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 and R&G will focus their efforts towards lodging formal requests for a pre-IND and End of Phase II meeting with the CFDA during the 4th quarter of 2018. The pre-IND meeting is a crucial step towards commencing Phase III clinical trials in China, with a view to gaining regulatory approval for the Chinese market. 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,” Dr Glass said.
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.
Dr Mitchell Glass said, “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.
The Cho Group of Hong Kong, the organisation that is funding the research and development of Invion’s PhotosoftTM technology, will fund CAT’s initial overhead and operating costs to enable the new company to establish a pathway with the CFDA.