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your-dietician · 4 years ago

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George Medicines initiates Phase III trials of triple combo candidate to treat hypertension – PharmaLive

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George Medicines initiates Phase III trials of triple combo candidate to treat hypertension – PharmaLive

George Medicines initiates two Phase III trials of triple combination candidate to treat hypertension

July 01, 2021 07:00 ET| Source: George Medicines

George Medicines initiates two Phase III trials of triple combination candidate to treat hypertension

Novel proprietary triple low-dose combination pill has been shown to outperform traditional blood pressure treatments without additional side effects in earlier clinical research

Lead candidate in Company’s pipeline of proprietary fixed-dose combination therapies targeting high unmet need in large patient populations suffering from non-communicable diseases such as CVD and Diabetes

London, UK, 1 July 2021 – George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the world’s leading causes of death, today announces the initiation of two Phase III trials investigating its proprietary triple combination candidate, GMRx2, as a first-line treatment for hypertension.

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients1 and a previous trial indicated triple low-dose combination therapy is statistically and clinically superior to standard of care, achieving better blood pressure control without increasing serious adverse effects. GMRx2 is a single pill triple combination in novel and proprietary dosage strengths containing telmisartan, amlodipine and indapamide, targeted for first line therapy to control hypertension.

George Medicines, a venture-backed spin-out company from The George Institute for Global Health, one of the world’s leading independent medical research institutes, is using its deep insights from academic research coupled with drug development and formulation expertise to combine best-in-class existing treatments in novel, fixed, ultra-low-dose combinations. These are intended to provide the optimal balance of high efficacy and improved safety, with potential for significant improvements in clinical outcomes and long-term adherence to treatment.

Hypertension is a major preventable risk factor for heart disease, stroke, kidney failure and heart failure, leading causes of mortality and morbidity in the USA. Over 100 million US adults have hypertension and only 1 in 4 have adequately controlled blood pressure – tens of millions need to start treatment, and tens of millions more need better treatment.2 Globally, over a billion people worldwide have hypertension, with most (two-thirds) living in low- and middle-income countries. Fewer than one in five people with hypertension have the problem under control.3

The Phase III trials follow successful earlier trials of a low dose triple combination which significantly outperformed traditional high blood pressure treatments without additional side effects. In those trials 70 per cent of patients receiving the combination reached their blood pressure target compared to just over half on their existing therapy4. If successful in Phase III trials, GMRx2 could be available for patients by 2023, subject to regulatory approval by the US Food and Drug Administration (FDA).

The first Phase III trial is an international, multi-center, randomised, double blind, active controlled, parallel group study, evaluating the safety and efficacy of GMRx2 in patients with high blood pressure compared to dual combinations of the same components. The trial’s primary outcome measure will be change in home systolic blood pressure (SBP) from baseline to week 12. The trial will enroll 1,500 patients and will be conducted across sites in seven countries, including the US and Australia.

A second Phase III trial with 250 patients is investigating the efficacy and safety of GMRx2 compared to placebo for the treatment of mild hypertension. The primary outcome measure of this trial will be the difference in change in home SBP from baseline to Week 4.

Prof Dr Anthony Rodgers, Chief Scientific Officer of George Medicines, said: “We are very pleased to be starting these two Phase III trials. High blood pressure is a leading cause of preventable morbidity and mortality globally and most people who are treated remain uncontrolled. Novel, low-dose combinations have great potential to substantially increase efficacy and improve adherence, while minimising adverse effects. George Medicines has recognised this and developed aunique, three component, single-pill combination, GMRx2, with the potential for superior efficacy, safety, adherence and access, beyond currently available treatment options.”

Dr Paul K. Whelton, MB, MD, MSc, FAHA, Show Chwan Chair in Global Public Health, Tulane University, and President-elect, World Hypertension League said: “Following the US Surgeon General’s Call to Action to Control Hypertension announced at the end of last year it is very good news that these two trials evaluating GMRx2 as a treatment for hypertension have commenced. Control of hypertension is a major unmet need, brought into more focus by COVID-19, to which patients with underlying conditions are most vulnerable. Trials such as those being conducted by George Medicines have the potential to help the millions of people worldwide with hypertension to live longer and healthier lives by enabling the provision of simple, affordable, effective and accessible medicines. If successful, these trials may have the potential to change the treatment paradigmof 1stline hypertension.”

For more information on the trials please visit clinicaltrials.gov (NCT04518293 and NCT04518306)

References

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71:e127-e248

U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020

World Health Organization https://www.who.int/news-room/fact-sheets/detail/hypertension

Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka JAMA. 2018;320(6):566-579. doi:10.1001/jama.2018.10359

Contacts:

George Medicines Stefan König, Chief Executive Officer [email protected]

Consilium Strategic Communications David Daley, Allison Connolly, Lindsey Neville Tel: +44 (0) 203 709 5700 [email protected]

About George Medicines

George Medicines is a late-stage drug development company focused on improving the management of non-communicable diseases with proprietary, innovative, single-pill, fixed-dose combinations of existing medicines.

Combining best-in-class molecules from existing medicines in novel fixed- and low-dose formulations, George Medicines is developing innovative and proprietary treatments that are more efficacious, safer and affordable than currently available treatment options. These single-pill, fixed-dose combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic diseases such as heart disease, hypertension, and diabetes, which remain the leading causes of premature death and disability worldwide.

George Medicines is building a strong and diversified pipeline of patented, single-pill, fixed-dose combination therapies in late stage development. Its lead candidate for the initial treatment of high blood pressure, GMRx2, has received clearance from the US Food and Drug Administration (FDA) to enter Phase III development.

George Medicines is a spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes in non-communicable diseases. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital Partners, Australia’s leading biomedical venture capital firm, backed by the Australian Government. For more information please visit www.george-medicines.com About Hypertension Hypertension, or elevated blood pressure, is a serious medical condition that significantly increases the risk of heart attack, stroke and kidney disease, among other issues. According to the WHO, hypertension affects 1.1 billion people worldwide, with two-thirds living in low- and middle-income countries. It is known as a “silent killer” as most people are unaware of the problem unless they are regularly tested. It is a major cause of premature death.

About GMRx2 GMRx2 is a single pill, triple component combination medicine and has been developed in 3 dosage forms: telmisartan 10mg, amlodipine 1.25mg and indapamide 0.625mg; telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg; and telmisartan 40 mg, amlodipine 5 mg and indapamide 2.5 mg.

Globe Newswire source:

https://www.globenewswire.com/news-release/2021/07/01/2256368/0/en/George-Medicines-initiates-two-Phase-III-trials-of-triple-combination-candidate-to-treat-hypertension.html

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hcsmca · 7 years ago

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The Human Brain and All Its Complexities

From thoughts and feelings to neurons and pathways, we humans have been trying to better understand our minds and uncover its mysteries ever since our brains developed the capacity for modern human cognition. However, despite the huge advancements brain research has made in recent decades, we are only beginning to scratch the surface of this intricate and fascinating organ. At TEDMED 2017, we’re putting the brain center stage with Speakers and Innovators who are doing groundbreaking work in fields such as brain development and genetics, neurodegenerative and neurological diseases, and human cognition.

Neuroscientist Guo-li Ming is creating and using brain organoids—miniature, simplified, lab-grown versions of organs—to model diseases and experiment with new treatment options. Specifically, Guo-li and her lab at the Perelman School of Medicine at the University of Pennsylvania are focused on the Zika virus and the severe brain defect it causes, microcephaly. After the recent outbreak of the Zika virus, no one knew what exactly was causing microcephaly, which was a major roadblock to helping patients and finding potential treatment options. However, in early 2016, Guo-li’s lab, along with researchers at two other universities, published groundbreaking studies that showed how damage to neural progenitor cells could explain the reduced brain volume in babies that had been exposed to Zika in the womb. Because of Guo-li’s research, doctors, scientists, and researchers have a better understanding of the disease— which will hopefully lead to a clearer path forward in terms of treating Zika patients.

Steven McCarroll is also exploring new ways to study the human brain and the conditions that affect its development and function. As a geneticist, Steven is particularly interested in the role that genes play in developing the brain differently in different people. At the McCarroll Lab in the Department of Genetics at Harvard Medical School, Steven and his team of scientists are developing new technology that combines genetics, molecular biology, and engineering in an effort to uncover the causes of mental illness. In 2016, the McCarroll Lab published studies linking schizophrenia to specific gene variations that recruit immune molecules into “pruning” synapses in the brain, a discovery that is leading toward new ways of thinking about the biological basis of schizophrenia and new approaches for discovering medicines to the treat the illness.

At Yumanity Therapeutics, Chee Yuen Chung and her teammates are working to develop new treatments for neurodegenerative diseases that are caused from protein misfolding. Currently, there are over 55 million people affected by these diseases, with no kind of effective cure or treatment to change the pathology of their conditions. Along with Chee, Yumanity’s Scientific Co-founder and Associate Director of Assay Development, the team focuses on repairing the specific phenotypes of the cells and pathologies of the diseases caused by protein misfolding. Their goal is straightforward: to develop novel therapies aimed at improving the outcomes for these patients. They do so by using an integrated three-platform system comprised of a phenotypic screening platform to model disease pathologies, a human neuronal platform, and a drug-target identification platform. Combining all three of these platforms allows Yumanity to expedite their process of identifying new possible disease-modifying drugs and targets to improve the prognosis for the millions of patients affected by neurodegenerative diseases worldwide.

Like neurodegenerative diseases, neurological diseases are a condition that affects millions of people—Parkinson’s alone affects 1 million Americans. At Cala Health, Founding CEO Kate Rosenbluth and her colleagues have embraced electricity as a novel therapy to target neural circuits to “retune’ the body. Their technology, neuroperipheral therapy™, combines innovations in three categories—medical devices, consumer electronics and individualized medicine—to provide non-invasive treatment for patients suffering from neurological diseases. Currently, Cala is working to alleviate the symptoms of the essential tremor by stimulating nerves using a body-worn electronic. With their technology, Cala hopes to use electricity as a means of providing individualized medicine and custom therapies to patients with a range of nervous system disorders.

Similar to Cala Health, Kernel is also developing new technology to help us better understand and treat various neurological diseases. Chief Commercialization Officer Dan Sobek and his teammates are not only working on next-generation brain interfaces that aim to treat neurological conditions like Parkinson’s Disease, but also mental and degenerative illnesses like depression and Alzheimer’s. In parallel, the company is also developing consumer-grade devices that are able to “listen” to the brain and gather information. By accessing and then interpreting the brain’s complexities, the team intends to develop applications to “illuminate the mechanisms of intelligence and extend cognition.” Ultimately, Kernel aims to explore the possibilities of enhancing the brain—making humans smarter and one day even interfacing with computers.

These Speakers and Innovators are working on ways to better understand the intricacies and address the challenges of the complex human brain. From creating brain organoids to model diseases and test treatments, to uncovering the gene variations associated with mental illness, to developing new treatment options for neurodegenerative, neurological, and degenerative diseases, TEDMED 2017 will feature individuals who are doing pioneering work in their fields to advance our understanding of our body’s most critical organ.

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