Quantum Genomics and its partners reach a new stage of development in Asia
- The phase III REFRESH study has been approved by the regulatory authorities and ethics committees in South Korea and Taiwan.
- Pre-marketing activities have been intensified with OEP and DongWha.
Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specialising in the development of a new class of drugs which act directly on the brain to treat difficult-to-treat/resistant hypertension and heart failure, announces the start of its pivotal REFRESH study in Asia.
Bruno Besse, Medical Director of Quantum Genomics, said:
“Following the approvals obtained in the United States, Canada and several European countries and the recruitment of the first patients, the approval of the REFRESH study by the Regulatory Authorities and the Ethics Committees in South Korea and Taiwan represents an important step in the development of firibastat. South Korean and Taiwanese centres are expected to recruit nearly 20% of REFRESH patients.”
Jean-Philippe Milon, Chief Executive Officer of Quantum Genomics, added:
“Starting the REFRESH study in Asia embodies our partnerships with DongWha (for South Korea) and Orient EuroPharma (for Taiwan, Southeast Asia, Australia and New Zealand), which finance the Asian stage of firibastat's development. The first patients should be recruited in the coming weeks, which will enable our partners to intensify their pre-marketing activities that are required before marketing. Milestone payments from our partners related to the inclusion the first South Korean and Taiwanese patients are expected before the end of the year.”
The REFRESH study should enable firibastat to be placed on the market at the end of 2023
The REFRESH study, a pivotal phase III study in difficult-to-treat and resistant hypertension, aims to demonstrate the efficacy of firibastat at 3 months and its long-term safety after a single daily dose of 1000mg. The study will recruit 750 patients with resistant or difficult to treat hypertension at 106 centres in 14 countries in Europe, the United States, Canada, South Korea and Taiwan. The first patient was recruited last July. The interim results of this pivotal study, which will enable the marketing application to be submitted, will be available in mid-2023.
The timelines for both the FRESH and REFRESH studies are perfectly aligned with the aim of putting firibastat on the market at the end of 2023.
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specialising in the development of a new class of cardiovascular drugs, based on the Brain Aminopeptidase A Inhibition (BAPAI) mechanism. It is the only company in the world to pursue this innovative approach directly targeting the brain, founded upon more than twenty years of research work by Paris-Descartes University and the INSERM/CNRS laboratory led by Dr. Catherine Llorens-Cortès at the Collège de France. Quantum Genomics thus aims to develop innovative treatments for complicated or even resistant hypertension (in approximately 30% of patients it is poorly controlled or treatment failure occurs), and heart failure (one in two patients diagnosed dies within five years).
Based in Paris and New York, the company is listed on the Euronext Growth market in Paris (FR0011648971 - ALQGC) and is registered on the US OTCQX market (symbol: QNNTF).