Quantum Genomics Provides Update on the Impact of the COVID-19 Health Crisis on Clinical Research Activities
PARIS and NEW YORK, April 07, 2020 (GLOBE NEWSWIRE) -- Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat difficult-to-treat and resistant hypertension and heart failure, has released an update on how the current COVID-19 health crisis will impact its clinical research activities.
Together with their partners, including suppliers, service providers, and clinical research organizations, Quantum Genomics is taking all necessary measures to maintain its clinical development activities while ensuring that the safety of its staff and enrolled patients remains its top priority.
EU and US health authorities have issued recommendations for clinical trials conducted during the crisis that aim to allow healthcare professionals to focus on managing COVID-19 patients, to ensure the safety of patients enrolled in trials, and to preserve the validity of trial results. Quantum Genomics is committed to strictly adhering to these recommendations.
The Company has also implemented mitigation plans to secure the supply of raw materials and the production of firibastat, which is made in France.
Quantum Genomics has taken all measures necessary to allow all of its employees to work remotely. All employees are therefore able to continue working on development projects.
Trial QGC001/1QG4: End-stage renal failure
This trial includes patients with renal failure and healthy volunteers. The healthy volunteers are enrolled at a later stage because they have to match the baseline characteristics of the former.
All patients with renal failure have already been enrolled and treated and firibastat assays are ongoing. Half of the healthy volunteers have already completed the trial, but enrollment has been temporarily halted, in accordance with recommendations from health authorities for clinical trials of this type.
In order to limit the impact of this enrollment interruption, an interim analysis will be conducted with data from all patients with renal failure as well as data from volunteers that were already enrolled. This interim analysis, the results of which we will disclose, will provide an initial assessment of firibastat kinetic parameters in patients suffering from renal failure. Once all healthy volunteers have been integrated, the trial will be completed and finalized.
Trial QGC001/2QG4 (QUORUM): Firibastat versus Ramipril after Acute Anterior Myocardial Infarction
Some of the patients included in the trial have already completed their follow-up visits and were fully evaluated.
For patients currently enrolled, follow-up visits are being reorganized and conducted remotely when possible. Furthermore, to comply with new local regulations, Quantum Genomics has begun shipping the treatments to the homes of patients when necessary to best ensure trial continuation. Inventory of the product used for trials has already been secured at all sites.
Recommendations from health authorities regarding clinical trials during the outbreak to allow healthcare professionals to focus on caring for COVID-19 patients could nevertheless have a temporary impact on the patient enrollment rate. To mitigate any possible slowdown in enrollment and to make sure the trial meets its timelines, Quantum Genomics will be adding additional trial sites in new countries. Site selection is already under way in order to ensure the new sites are operational once the health crisis ends.
Trial QGC001/3QG1 (FRESH): Resistant Hypertension
The current situation has little impact on the FRESH trial. Regulatory authorities and ethics committees in both Europe and the United States have organized themselves to continue evaluating clinical trials, with priority given to COVID-19 trials, however. Some countries—including Canada—have already approved the FRESH trial. All sites have been selected, and products and equipment are ready to be shipped. Patient enrollment will start as soon as possible and therefore the Company believes there will be no material impact on guidance regarding the trial timeline.
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 directed by Dr. Catherine Llorens-Cortes 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 severe 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). For more information, please visit www.quantum-genomics.com, or follow us on Twitter and LinkedIn
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