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George Medicines advances triple combination candidate GMRx4 into Phase II clinical development for first-line treatment of type 2 diabetes

·6-min read
George Medicines
George Medicines

George Medicines advances triple combination candidate GMRx4 into Phase II clinical development for first-line treatment of type 2 diabetes

  • GMRx4 is the second candidate to be prioritised in Company’s pipeline of proprietary fixed-dose combination therapies targeting non-communicable diseases

  • George Medicines receives $1.5 million investment from Australia’s national biotechnology incubator CUREator

London, UK, 20 July 2022 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 it has advanced GMRx4, its novel proprietary ultra-low-dose triple combination candidate as a first-line treatment for type 2 diabetes into Phase II clinical development. This progression is supported by the award of a AUS$1.5 million grant from CUREator, Australia’s national biomedical incubator managed by Brandon BioCatalyst, alongside investment from George Medicines as the Company prioritises its pipeline portfolio.

GMRx4 is being developed to provide a synergistic effect from three best-in-class type 2 diabetes treatments – metformin, dapagliflozin and sitagliptin – and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and safer treatment regimen than existing therapies for newly diagnosed patients.

Stefan König, CEO of George Medicines, said: “Today’s news marks a significant milestone for George Medicines as we advance GMRx4 into Phase II clinical studies as a first-line treatment for type 2 diabetes. This is our second candidate targeting a major non-communicable disease to progress in development, and follows in the path of our lead asset, GMRx2, another triple combination pill, which is currently in Phase III trials as a first-line treatment for hypertension. This program will enable George Medicines to further diversify its academic and commercial partnerships and brings us another step closer in making candidates from our pipeline available to patients.

“We are proud that GMRx4 has been recognized by CUREator as an innovative and much needed therapy. Type 2 diabetes is a devastating chronic illness that carries a socioeconomic burden for people and health care systems despite it being a preventable and treatable condition. We believe the synergy of combining three best-in-class medications in a low-dose, single pill combination to be given early on as a first-line treatment will help patients better control their diabetes with fewer side effects and improved adherence so they can lead productive and healthy lives.”

While first-line treatment of type 2 diabetes tends to comprise metformin monotherapy alongside lifestyle modifications, many patients do not achieve or maintain their recommended glycaemic control, which leads to higher dosing or multiple medicines and, in turn, unwanted side effects and challenges in therapy adherence. Each component of GMRx4’s proprietary combination is below the lowest dose currently approved by the US Food and Drug Administration (FDA) and as little as half the lowest strength currently manufactured. As a first-line treatment, given at an ultra-low dose in a single pill formulation, GMRx4 is intended to enable patients to take fewer pills to manage their condition, with fewer side effects.

Preclinical and Phase I data1 showed GMRx4 significantly reduced whole blood glucose levels in comparison to other combination approaches and significantly decreased HbA1c (%) as compared to other tested treatment combinations. George Medicines’ Phase II trial investigating GMRx4 is expected to commence later this year.

Dr Simon Wilkins, CUREator Head of Operations, said: “CUREator is delighted to support George Medicines as a successful round one awardee for the clinical stream as it continues to maximise the development of its promising therapeutic program here in Australia. This funding will support George Medicine’s clinical development program, progressing its asset towards regulatory approval and market launch. Ultimately, this means it will be better positioned to achieve commercial success and have a positive, global impact on patient lives and that’s entirely what CUREator is here to support.”

End –

Contacts:

George Medicines
Stefan König, Chief Executive Officer
info@george-medicines.com

Consilium Strategic Communications
David Daley, Lindsey Neville, Isabelle Abdou
Tel: +44 (0) 203 709 5700
georgemedicines@consilium-comms.com

About George Medicines

George Medicines is a late-stage drug development company focused on improving the management of non-communicable diseases (NCDs) 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 accessible 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 NCDs including hypertension, cardiovascular disease and type 2 diabetes, which remain the leading causes of premature death and disability worldwide.

The Company is building a strong and diversified pipeline of patented, single-pill, fixed-dose combination therapies. Its lead candidate, GMRx2, is in Phase III development for the initial treatment of hypertension and under investigation for the prevention of recurrent intracerebral haemorrhage (stroke).

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, Australia’s leading life sciences venture capital firm, backed by the Australian Government. For more information, please visit www.george-medicines.com.

About GMRx4
GMRx4 is a single pill, triple component combination medicine and has been developed from 3 existing best-in-class drugs and formulated at an ultra-low dose: metformin XR 350mg, dapagliflozin 2.5mg and sitagliptin 17.5mg. GMRx4 is being tested for the treatment of type 2 diabetes with the aim of making a safer, more effective and easier treatment regimen for patients worldwide and to alleviate the socioeconomic burden of such non-communicable diseases.

About Diabetes
Diabetes is a lifelong chronic condition where the pancreas does not produce enough insulin -- a hormone that regulates blood sugar -- or when the body cannot effectively use the insulin it produces. Hyperglycemia, or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to disorders of the circulatory, nervous and immune systems. Type 2 diabetes is the most common type of diabetes, affecting 90% of the more than 537 million adults with diabetes worldwide2, and is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation3.

About CUREator
Delivered by Brandon BioCatalyst, CUREator is backed by the Australian Federal Government’s Medical Research Future Fund. The MRFF’s $80 million Early Stage Translation and Commercialisation Support Grant (ESTAC) aims to assist businesses to develop projects that support medical innovation in Australia through to proof-of-concept and beyond, providing opportunities for commercialisation. CUREator is responsible for managing $40m of this fund, dedicated to supporting commercialisation of both preclinical medical innovations and early clinical development of therapeutics. For more information about CUREator visit: https://brandonbiocatalyst.com/cureator/

1 Data on file
2 International Diabetes Federation
3 World Health Organization


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