Quantum Genomics Enrolls First Patient in Its Pivotal Phase III REFRESH Trial of Firibastat in Difficult-to-Treat and Resistant Hypertension with Once-a-Day Formulation of Firibastat

Rhea-AI Summary

Quantum Genomics has commenced the REFRESH study, enrolling its first patient for a pivotal phase III trial of firibastat, targeting treatment-resistant hypertension. This multicenter study will involve 750 patients across 96 sites in various countries including the US and South Korea. The trial aims to assess the medication's effectiveness and safety over several months, with results expected by mid-2023. The company is preparing for a New Drug Application by Q4 2023, aligning with FDA standards for this innovative treatment.

Positive

• First patient enrolled in REFRESH study, indicating progress in clinical development.
• Study aligns with FDA-endorsed development plan, enhancing credibility.
• Expected results by mid-2023 may support upcoming New Drug Application.

Negative

• No immediate financial metrics provided to gauge impact on revenue or profits.
• Potential risks associated with clinical trial outcomes affecting market authorization.

PARIS, July 08, 2021 (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, today announced the enrollment of the first patient in the Company’s REFRESH study (Randomized study of Extended treatment with Firibastat in treatment-RESistant Hypertension) in difficult-to-treat⁽¹⁾ or resistant⁽²⁾ hypertension. The study is being conducted jointly with its partners DongWha for South-Korea and Orient Europharma for South-East-Asia, Australia and New Zeland.

“We are thrilled to enroll the first patient in our pivotal phase III study with the new once-a-day formulation of firibastat,” said Jean-Philippe Milon, chief executive officer of Quantum Genomics. “This study, aligned with the FDA¹-endorsed development plan is the last step before submission for market authorization in difficult-to-treat/resistant hypertension planned in Q4 2023.”

This multicenter, multinational study will enroll 750 patients with difficult-to-treat² or resistant³ hypertension in 96 study sites in Europe, Canada, US, Taiwan, and South-Korea.

For the first double-blind randomized three-month period, 750 patients will receive firibastat (1000mg once-a-day) or placebo, on top of their current therapy. The primary endpoint will be reduction in systolic automated office blood pressure (AOBP) from baseline. After this first period, subjects will be treated and followed-up for six additional months (and 12 months for 100 patients) to assess long-term safety, data that are mandatory for New Drug Application (NDA) for a chronic treatment.

Efficacy results and six-month safety results – that will support the New Drug Application - are expected for mid-2023.

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 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

Contact

Quantum Genomics

Contact@quantum-genomics.fr

So Bang (Europe)

Financial and Media communication Quantum-genomics@so-bang.fr

LifeSci (USA)

Mike Tattory Media Relations and Scientific Communications +1 (609) 802-6265 | mtattory@lifescicomms.com

 

¹ FDA : Food and Drug Administration
² Patients not controlled despite two antihypertensive classe, at maximum tolerated doses
³ Patients not controlled despite at least three antihypertensive classes, including a diuretic, at maximum tolerated doses

FAQ

What is the REFRESH study by Quantum Genomics?

The REFRESH study is a phase III clinical trial assessing firibastat for treatment-resistant hypertension.

When will Quantum Genomics' New Drug Application be submitted?

Quantum Genomics plans to submit its New Drug Application in Q4 2023.

How many patients are involved in the REFRESH study?

The REFRESH study will enroll 750 patients.

What is the expected timeline for results from the REFRESH study?

Efficacy and safety results are expected by mid-2023.

What type of hypertension is firibastat targeting?

Firibastat targets difficult-to-treat and resistant hypertension.