DalCor Pharmaceuticals Canada, Inc.

CAMBRIDGE, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, today announced the appointment of Paul Fonteyne, MS, MBA, to its Board of Directors as an Independent Director. Fonteyne brings decades of experience in corporate leadership in biopharmaceuticals as well as a track record of commercial success, including as the former President, CEO and Chairman of Boehringer-Ingelheim USA. Fonteyne replaces Ruoxi (Rosy) Hu, PhD, from Morningside Technology Advisory, LLC, who stepped down from the Board. “Paul Fonteyne brings critical expertise as we begin to build our commercial strategy for AD109, our lead oral treatment candidate for obstructive sleep apnea,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “Paul’s operational and commercial experience provides the skills and perspective to help position the company for continued growth. We also want to thank Rosy Hu for her support and counsel while on the Board.” “I’m excited to join Apnimed’s Board of Directors as the company enters its next phase of development,” said Fonteyne. “Apnimed has the opportunity to change the way obstructive sleep apnea is treated for the millions of Americans who currently cannot or will not use existing therapies. I’m looking forward to working with the Apnimed team to achieve their business and clinical goals.” Fonteyne has more than 30 years of experience in the biopharmaceutical industry, including 15 years of leadership roles in the United States and globally with Boehringer-Ingelheim. He was named President and CEO of Boehringer-Ingelheim USA in November 2011 and subsequently served as its Chairman until he retired in January 2019. Paul also held commercial leadership roles at Merck and Co. Inc. for nine years and at Abbott Laboratories for eight years. Fonteyne is on the board of several clinical and commercial stage biotechnology companies, including Apellis, Amylyx, Ypsomed and DalCor. He also serves as an Executive in Residence to Canaan Partners, a Venture Capital Fund dedicated to Health Care and Technology early-stage venture investing. Paul has served on the board of PhRMA and chaired the National Pharmaceutical Council. He holds an MS in Chemical Engineering from the University of Brussels and an MBA from Carnegie Mellon University. About AD109AD109 has the potential to be the first oral pharmacologic that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of current standard of care treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3. About Obstructive Sleep ApneaObstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 million Americans, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which can cause dramatic reductions in overnight oxygen saturation and often leads to poor sleep, and in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated, undertreated and at risk. About ApnimedApnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact:Amanda BreedingScientPRamanda@scientpr.comInvestor Contact:Wendy GabelKendall Investor Relationswgabel@kendallir.com

MONTREAL, Sept. 13, 2023 (GLOBE NEWSWIRE) -- DalCor Pharmaceuticals today announced the closing of the company’s Series D financing round of $80m USD to conduct the Dal-GenE-2 confirmatory trial in North America under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Dal-GenE-2 (Dal-302), a phase III, double-blind, randomized placebo-controlled study, will evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction (MI) in approximately 2,000 patients with a documented recent acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene. “Following the dal-GenE trial results showing a potential benefit in a genetically defined patient population, we are pleased to have reached agreement with the FDA to conduct the Dal-GenE-2 confirmatory trial to support a potential new drug application (NDA) filing,” said Dr. Fouzia Laghrissi Thode, CEO of DalCor Pharmaceuticals. This confirmatory trial follows the results of the dal-GenE trial which showed a 21% relative risk reduction (RRR) in fatal and non-fatal MI in 6,149 patients across 34 countries, and a 45% RRR in 1,200 patients in North America and confirmed the safety profile of dalcetrapib. “The AA genotype frequency is up to 20% in European populations and is higher than 40% in populations of African ancestery,” said Dr Eldrin F. Lewis, Chief of the Division of Cardiovascular Medicine at Stanford University, Professor of Cardiovascular Medicine, and Chair of the Dal-GenE-2 diversity committee. “With the relative risk reduction seen in North American patients in the dal-GenE study and the continued commitment to investigating the first potential pharmacogenetic precision medicine for patients with cardiovascular disease, we are pleased to partner with DalCor Pharmaceuticals in this confirmatory trial.” The Series D financing includes the participation of Fonds de Developpement Économique from the Québec government managed by Investissement Québec and Fonds Propres d’ Investissement Québec as well as current investors including Andes Growth, TB Pharma, Fonds de Solidarité FTQ, and CTI Life Sciences. “Québec’s life-sciences expertise is recognized worldwide. Our government is keen to support projects with the potential to generate meaningful spinoffs, like DalCor’s work on cardiovascular health,” said Pierre Fitzgibbon, Minister of Economy, Innovation and Energy, Minister Responsible for Regional Economic Development and Minister Responsible for the Montréal Region. “We are pleased to support DalCor in this round of financing so they can carry on development in precision medicine for cardiovascular disease,” said Guy LeBlanc, President, and CEO of Investissement Québec. “Their research can ultimately revolutionize their industry and reduce the number of cardiovascular events. Investissement Québec will keep supporting emerging young businesses to position Québec in key sectors of our economy, such as life sciences.”- - Notes: Dal-GenE-2: The primary objective of Dal-GenE-2 is to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in 2,000 patients with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene. The trial is expected to start in Q3 2023 with an interim efficacy analysis in 2026, and completion anticipated in 2027. Dal-GenE: While the trial missed the primary endpoint, most likely due to the impact of the COVID-19 pandemic, the results show a 21% relative risk reduction (RRR) in fatal and non-fatal MI in 6,149 patients across 34 countries, and 45% RRR in 1,200 patients in North America. These data support the further development of dalcetrapib. DalCor Pharmaceuticals: DalCor Pharmaceuticals is pioneering precision medicine for patients with cardiovascular disease. By combining genetic and clinical insights, the company’s development program, dalcetrapib, is intended to reduce fatal and non-fatal myocardial infarction (MI) following a recent acute coronary syndrome and deliver superior cardiovascular outcome in a specific genetic subset of patients. DalCor Pharmaceuticals holds the worldwide exclusive license to develop, manufacture and commercialise dalcetrapib, and holds the right to the genetic marker for use with dalcetrapib in patients with the AA genotype at variant rs1967309 in the ADCY9 gene. A companion diagnostic test, developed in conjunction with Roche Diagnostics, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment. For more information, visit www.dalcorpharma.com.

Trial was negatively impacted by the COVID-19 pandemic and did not meet the primary endpoint. However, the results validate the interaction between dalcetrapib treatment and AA genotype at variant rs1967309 in the ADCY9 gene.LONDON and MONTREAL, July 21, 2022 (GLOBE NEWSWIRE) -- DalCor Pharmaceuticals announced the results of the dal-GenE Phase 3 cardiovascular precision medicine outcomes trial with publication of ‘Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial’ in the European Heart Journal.1 The dal-GenE (DAL-301) trial was initiated to determine the ability of dalcetrapib to reduce cardiovascular (CV) morbidity and mortality in a population experiencing an acute coronary syndrome (ACS) within 1-3 months before randomization (N=6147) and identified as carrying the AA genotype at variant rs1967309 in the adenylate cyclase type 9 (ADCY9) gene, as determined by the cobas® ADCY9 genotype test. This AA genotype is carried by approximately 20% of the total population and up to 40% in people of African descent. Eligible patients were optimally treated for CV risk factors. The prespecified primary endpoint was time-to-first event for the composite of CV death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) or non-fatal stroke. In the dal-GenE trial, treatment with dalcetrapib in the intent-to-treat (ITT) analysis did not demonstrate a statistically significant result, with the composite primary endpoint event occurring in 9.5% of the patients in the dalcetrapib group, as compared with 10.6% in the placebo group (hazard ratio (HR) 0.88; 95% CI 0.75-1.03; p=0.12). However: On fatal and non-fatal MI, the dalcetrapib treatment showed a relative risk reduction of 21% compared to placebo (5.9% vs. 7.3%; HR 0.79; 95% CI 0.65-0.96; p=0.02). Dalcetrapib was safe and well tolerated in the dal-GenE trial.For the seven months prior to the COVID-19 pandemic, the hazard ratio and p-value in the dal- GenE trial were consistently clinically meaningful (HR< 0.85) and statistically significant (p<0.05).Study results censored on January 2020, prior to the COVID-19 pandemic, showed a relative risk reduction of 18% (HR = 0.82, 95% CI, 0.68-0.98; p=0.03) in the occurrence of the primary endpoint in the dalcetrapib treated group compared to placebo indicating that dalcetrapib appeared to be associated with this benefit up to the emergence of COVID-19.COVID-19 occurred as early as January 2020 worldwide and had a global impact on cardiovascular care. In particular, the numbers of patients diagnosed and hospitalized with myocardial infarction decreased steeply, while deaths increased. The dal-GenE study endpoints appear to have been impacted by the last 17 months of follow-up that occurred during COVID- 19 pandemic. The ratio of non-fatal events to death dropped from 1.7 to 0.9 during this period, most likely due to a reduction of reporting in non-fatal events and an increase in CV and non-CV death during the pandemic compared to pre-COVID. This finding is consistent with the published impact of the pandemic on cardiovascular care2.A pre-specified on-treatment sensitivity analysis of the primary endpoint showed a relative risk reduction of 17% with dalcetrapib treatment compared to placebo (7.8% vs. 9.3%; HR 0.83; 95% CI 0.70-0.98, p=0.03).Further pre-specified analyses demonstrated that patients at a higher risk had greater benefits on dalcetrapib treatment. In patients with type 2 diabetes, the observed relative risk reduction with dalcetrapib was 23% versus placebo (HR = 0.77; 95% CI, 0.60-0.99, p=0.04).In North America, where randomized patients were at a higher risk, they had a relative risk reduction of 41% in the primary composite endpoint (HR 0.59; 95% CI, 0.42-0.82, p=0.002). In contrast, countries with low-risk patients representing 20% of randomized patients had no significant benefit. Pre-COVID-19, the clinical efficacy of dalcetrapib seen in the dal-GenE study was also consistent with that of the retrospective analysis conducted in patients with the rs1967309 AA genotype in the dal-OUTCOMES study3. The totality of these data validates the pharmacogenetic hypothesis that dalcetrapib can safely improve, beyond the current standard of care, the prognosis of ACS patients with the rs1967309 AA genotype. DalCor is working closely with Health Authorities to determine the path forward for the approval of dalcetrapib for the treatment of patients with the rs1967309 AA genotype following an ACS event. About DalCorDalCor is a biopharmaceutical company with a focus on addressing cardiovascular disease, the greatest global healthcare burden. Our purpose is to deliver the first pharmacogenomic precision medicine in cardiovascular disease that specifically targets patients with the ADCY9 AA genotype. For more information, please visit dalcorpharma.com. About dal-GenEdal-GenE was a double-blind, parallel-group, placebo-controlled, randomized trial comparing orally administered dalcetrapib 600 mg once daily with placebo in a 1:1 ratio in patients with an acute coronary syndrome within 1 to 3 months and the AA genotype at variant rs1967309 in the ADCY9 gene. A total of 6147 patients were randomly assigned to receive dalcetrapib 600 mg or placebo daily. The primary endpoint was the time from randomization to first occurrence of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke. Participants were enrolled across 630 investigational sites located in North America, South America, Europe, Middle East, South Africa, Australia, and New Zealand. Patients were eligible if they were at least 45 years of age, recently hospitalized for an acute coronary syndrome within the previous 1 to 3 months, clinically stable, treated with guidelines-based management of LDL- cholesterol at a minimum to a target level less than 2.6 mmol/L, and confirmed in a central laboratory to have the AA genotype at variant rs1967309 in the ADCY9 gene. About DalcetrapibDalcetrapib is potentially the first pharmacogenomic precision medicine in cardiovascular disease developed for patients with the ADCY9 AA genotype. A companion diagnostic test, developed in conjunction with Roche Molecular Systems, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment. DalCor obtained global rights to develop, manufacture and commercialize dalcetrapib under a license and collaboration agreement with Roche. References Tardif JC, Pfeffer MA, Kouz S, et al. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J 2022. European Heart Journal (2022) 00, 1–10 https://doi.org/10.1093/eurheartj/ehac374Nadarajah R, Wu J, Hurdus B, et al. The collateral damage of COVID-19 to cardiovascular services: a meta-analysis. European Heart Journal (2022) 00, 1–15 https://doi.org/10.1093/eurheartj/ehac227.Schwartz GG, Olsson AG, Abt M, et al. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012;367(22):2089–2099. Media Contact:Clare EvansIris Communication+1 403 888 6869clare.evans@iriscommunication.net