Firibastat meets primary endpoint and demonstrates highly significant and clinically relevant efficacy in high cardiovascular risk, diverse population whose hypertension is typically difficult to treat
These results open the way to a pivotal Phase 3 trial with firibastat in resistant hypertension
Conference call and webcast today, November 12 at 4:00 p.m. CET/10:00 a.m. EST
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 hypertension and heart failure, today announced excellent top-line results from its Phase 2b NEW- HOPE trial of firibastat, a first-in-class brain aminopeptidase A inhibitor (BAPAI), for the treatment of arterial hypertension. The data were presented in a late-breaking oral presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) held November 10-12, 2018 in Chicago. The Company will also be hosting a conference call and webcast today to discuss the study results at 4:00 p.m. CET/10:00 a.m. EST.
“The NEW-HOPE study results support the potential for firibastat to be a safe, effective and well-tolerated treatment for arterial hypertension across an understudied population of diverse, high-risk hypertensive patients,” said Jean-Philippe Milon, Chief Executive Officer of Quantum Genomics. “These data represent the most significant milestone for Quantum Genomics to date and not only bring us closer to serving an area of significant unmet need, but also position firibastat for a pivotal Phase 3 trial in resistant hypertension.”
Primary endpoint met: highly significant (p < 0.0001) decrease of 9.7 mmHg in automated systolic blood pressure
Primary investigator of the study Professor Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA, of Tulane University School of Medicine (New Orleans), presented the results from the Phase 2b trial. Results showed that eight weeks of treatment with firibastat led to a statistically significant decrease of 9.7 mmHg in systolic automatic office blood pressure (AOBP) from baseline (p < 0.0001), which was the primary endpoint of the trial. Diastolic AOBP, a secondary endpoint, showed a reduction of 4.3 mmHg (p < 0.0001).
“A minimum decrease of 7 mmHg in systolic AOBP represents a clinically relevant benchmark in difficult-to-treat hypertensive patients and this goal was largely exceeded in the NEW-HOPE trial,” said Dr. Bruno Besse, Chief Medical Officer of Quantum Genomics. “Based on these results and the magnitude of the observed blood pressure decrease, we are encouraged by the outcome of this trial and are optimistic about the promise of firibastat.”
Firibastat proved efficacious in all subgroups
The efficacy of firibastat in lowering blood pressure (BP) was proven in all subgroup analyses, including age, sex, ethnic origin and weight. In particular, a statistically significant decrease in systolic AOBP was found in obese (-10,4 mmHg, p < 0.0001), as well as in black patients (-10,5 mmHg, p < 0.0001), a high cardiovascular risk population in which angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers are marginally effective and not recommended as first-line monotherapy according to current European and US guidelines.
Firibastat was clinically and biologically well-tolerated
Overall, firibastat was well-tolerated. The most common side-effects were skin reactions and headaches, with occurrence frequencies of 4% and 3% respectively, which is similar to what is observed with other classes of antihypertensive drugs. No angioedema was reported. No changes in serum potassium or sodium levels were observed. Blood glucose levels and renal function remained stable.
The Phase 2b NEW-HOPE (NCT03198793) multicenter, open-label, dose-titrating safety and efficacy study enrolled 256 overweight or obese patients with primary hypertension from populations known to have increased incidence of treatment-resistant hypertension, including at least 50% African American and Hispanic individuals. After a 2-week wash-out period, subjects received firibastat for 8 weeks (250 mg twice-a-day orally for 2 weeks, then 500 mg twice-a-day if AOBP>140/90 mmHg; hydrochlorothiazide 25 mg once daily could be added after 1 month if systolic AOPB≥160 mmHg and/or diastolic AOBP ≥100 mmHg). The primary endpoint of the trial was a change from baseline in systolic AOBP after 8 weeks of treatment, and key secondary endpoints include diastolic AOBP, ABPM and safety.
Interested parties may access the live webcast directly through the link below, and a recorded replay of the presentation will be available on the “Investors” section of the Company's website following its conclusion.
Webcast in English on Monday, November 12, 2018 at 4:00 p.m. CET/10:00 a.m. EST
Link to attend webcast: http://www.digitalvideo.fr/quantumgenomics/
A replay of the webcast will be made available in the Investors section of the Company's website www.quantum-genomics.com.
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 its 20-plus years of basic and clinical research at some of the largest French laboratories: the French National Institute of Health and Medical Research (INSERM), the French National Centre for Scientific Research (CNRS), the Collège de France, and Paris-Descartes University. 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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- APPENDIX -
Cardiovascular diseases, a public health challenge
Cardiovascular diseases are the first cause of mortality in the world, causing 17.5 million deaths, representing 31% of total global mortality. In France alone, despite considerable therapeutic progress, cardiovascular diseases are the root cause of around 140,000 deaths per year; they are also one of the main causes of morbidity with 11 million patients treated for vascular risk. In total they represent 28 billion euros annual expenditure.
Arterial hypertension, the most common cardiovascular disease
Arterial hypertension is a silent killer, not always diagnosed as there are no symptoms. Even if a blood pressure reading is practically a matter of routine at any medical check-up, only half of adults with high blood pressure know they are hypertensive, and among the patients treated, only half have well-controlled blood pressure. However, arterial hypertension is a common disease (it affects one in three adults) the complications of which are severe as it causes 62% of cases of stroke for example.
Restrictive and not always effective treatments
The most recent drugs used in arterial hypertension and heart failure inhibit the Renin Angiotensin Aldosterone system peripherally, which is one of the key elements of cardiovascular system regulation.
In arterial hypertension, current treatments, often used in bi or tritherapies, often have unpleasant side effects and at least 30% of hypertensive patients are poorly controlled, or even resistant. Also, 50% of patients taking an antihypertensive stop taking it within 1 year.
The new therapeutic group developed by Quantum Genomics is therefore promising for millions of patients worldwide.