Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today presents its 2019 corporate action plan.
The end of 2018 was marked by the acceleration of Quantum Genomics' Phase IIb study NEW-HOPE, and the publication of very positive results from this study six months ahead of schedule. Following this announcement, our team presented these results at several financial or scientific events and fine-tuned our current research programs in resistant hypertension and heart failure.
Pivotal Phase III study in resistant hypertension
The NEW-HOPE study demonstrated highly significant anti-hypertensive effect of firibastat, the first and only compound of a new therapeutic class (Brain Aminopeptidase A Inhibitors, BAPAIs), in patients at high cardiovascular risk. The efficacy and safety of firibastat in patients whose hypertension is generally difficult to treat supports Quantum Genomics' strategic decision to pursue its clinical development in resistant hypertension.
Resistant hypertension is a major public health problem that affects at least 15% of hypertensive people worldwide, for which there is no treatment and very little innovation, highlighting the need for new therapies. Quantum Genomics targets a market of more than 150 million patients worldwide. Firibastat has the potential to become a blockbuster with estimated annual sales in the $2 billion and $3 billion range.
The steering committee appointed in January to implement this study and also recently joined by Alexandre Persu (Brussels, Belgium), will meet on February 18 to elaborate on the design of the study that will be presented to the regulatory authorities (Food and Drug Administration and European Medicines Agency in order to start the clinical trial in the second half of 2019.
In parallel, Quantum Genomics is developing controlled release firibastat tablets for once-daily administration. This dosage should enhance the attractiveness of firibastat and optimize patient adherence to the treatment. The results of this study should be available during the second quarter of 2019.
Launch of QUORUM, a Phase IIb study in heart failure
Quantum Genomics is launching QUORUM, a Phase IIb study to evaluate the efficacy and safety of firibastat compared to ramipril in heart failure patients after acute myocardial infarction (AMI). The first patients will be included at the beginning of the second quarter of 2019.
This multicenter, multinational, randomized, double-blind study with 3 parallel groups will enroll 300 patients, included in the 24 hours after an acute myocardial infarction, treated with primary angioplasty. This study is resolutely ambitious and should constitute a proof of concept in a disease for which epidemiological records and clinical studies highlight the need for new therapeutic approaches to reduce the morbidity and mortality of post-IDM heart failure. The 38 planned clinical centers have already been selected and the application was submitted to the regulatory agencies in the various concerned countries. The first patients will be included at the beginning of the second quarter of 2019.
A reaffirmed ambition: preparing the launch on the market of a new class of cardiovascular medications to treat resistant hypertension and heart failure
Since last November and the announcement of NEW-HOPE's results, there have been many expressions of interest for a partnership. Quantum Genomics is currently in discussions with several laboratories wishing to expand their products portfolio in the field of cardiovascular diseases.
In conclusion, Jean Philippe Milon, Chief Executive Officer of Quantum Genomics, said:
"2018 was a major turning point for Quantum Genomics. We are making every effort to take further steps in 2019 to prepare the commercialization of firibastat. The conditions for signing a partnership are met today and I am confident in our ability to achieve this potential in the coming months. While it is still too early to give more details, discussions with potential partners are progressing in the interest of patients and investors who support us. »
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specializing in the development of a new class of cardiovascular medications based on brain aminopeptidase A inhibition (BAPAI). Quantum Genomics is the only company in the world exploring this innovative approach that directly targets the brain. The company relies on 20 years of academic research from the Paris-Descartes University and the laboratory managed by Dr. Catherine Llorens-Cortès at the Collège de France (French National Institute of Health and Medical Research (INSERM)/ the Scientific Centre for National Research (CNRS)). The goal of Quantum Genomics is to develop innovative treatments for complicated, or even resistant, cases of hypertension (around 30% of patients have poor control of their condition or receive ineffective treatment) and for heart failure (one in two patients diagnosed with heart failure dies within five years).
Based in Paris and New York, Quantum Genomics is listed on the Euronext Growth exchange in Paris (FR0011648971- ALQGC) and trades on the OTCQX Best Market in the United States (symbol: QNNTF).
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