George Medicines files New Drug
Application with FDA for novel low dose triple combination for
treatment of hypertension following successful international Phase
III development program
- Multi-mechanism, triple
combination of existing best-in-class medicines in novel low dose
single pill, GMRx2 has potential to be the only triple combination
product for management of hypertension, including initial
treatment
- Two international Phase III clinical trials for the
treatment of hypertension, vs dual therapy and placebo, met all
primary efficacy and safety endpoints
- Study results from both trials planned for publication
by the end of the year
London, UK 6 August 2024 –
George Medicines, a late-stage, biopharmaceutical company
addressing significant unmet need in the treatment of
cardiometabolic disease, today announces its submission to the US
Food and Drug Administration (FDA) of a New Drug Application (NDA)
for GMRx2, George Medicines’ lead pipeline candidate for the
treatment for hypertension, including initiation of treatment.
The application was based on the achievement of
all primary efficacy and safety endpoints in the Company’s two
Phase III studies evaluating its multi-mechanism, triple
combination single pill of existing best-in-class medicines,
telmisartan, amlodipine and indapamide, in novel low doses, versus
dual therapy and placebo.
Mark Mallon, Chief Executive Officer of
George Medicines, said: “It is time for a new approach to
tackle what remains one of the leading causes of death and
disability, and a major risk factor for heart attacks, heart
failure, stroke, kidney failure and dementia1,2. Hypertension
affects nearly one in two adults in the US and only a quarter of
those are controlled3. This leaves more than 70 million patients
without their blood pressure controlled, often because of
suboptimal treatment.
“GMRx2’s potential to deliver rapid and
effective blood pressure control and a favourable tolerability
profile, provides an opportunity to transform the management of
hypertension. We look forward to the outcome of the regulatory
process, alongside our ongoing activities to secure
commercialization partners for GMRx2, so that we can bring the
value of this important medicine to patients.”
Designed for optimal efficacy, safety and
adherence, GMRx2’s multi-mechanism approach, at lower dosing than
today’s therapies, delivers the synergistic efficacy benefits of a
triple therapy while maintaining tolerability. GMRx2 is expected to
be an important new option for physicians and patients, initially
in the $12 billion US hypertension market4, and then globally,
including in low- and middle-income countries whose populations
carry a significant hypertension burden1.
George Medicines conducted two randomized,
controlled Phase III studies to support its FDA regulatory
submission. Study 1 was 4 weeks in duration with 295 subjects
receiving GMRx2 or placebo. Study 2 involved a 4-week active run-in
period, during which 2,244 subjects received GMRx2 followed by a
12-week randomized period in which 1385 subjects received GMRx2 or
one of the three component two-drug combinations.
The primary efficacy endpoint in both studies
was change in home systolic blood pressure (SBP) from baseline and
the primary safety endpoint was difference in withdrawals for
adverse events.
The two studies are expected to be published by
the end of the year.
George Medicines is a spin-out company from The
George Institute for Global Health, one of the world’s leading
medical research institutes with a focus on addressing global
health inequity. The Company’s GMRx2 development program built on
earlier research by The George Institute, including the 700-patient
TRIUMPH trial, undertaken in Sri Lanka in 2016/17 which found that
among patients with mild to moderate hypertension, treatment with a
low dose, single-pill, triple combination led to an increased
proportion of patients achieving their target blood pressure goal
versus usual care5.
Hypertension treatment today
The US Surgeon General’s Call to Action to Control Hypertension,
published in 20203, outlined the limitations in, and the complexity
of, the current hypertension treatment pathway, leading to poor
patient outcomes. In the US nearly half of adults have hypertension
(120 million) and only around 1 in 4 of those have their
hypertension under control (27.0 million)1, either because
they are not being treated or their treatment is suboptimal.
Too many diagnosed patients aren’t achieving
sufficient blood pressure control because they are on inadequate
therapy, aren’t receiving the right combination of medicines at the
right doses or aren’t taking their treatment as prescribed or
continuing their treatment in the long term.
The major, globally recognized treatment
guidelines6 recommend the use of fixed dose combination therapy for
most patients with hypertension, including for first-line treatment
and yet, in practice, newly diagnosed patients will often still be
prescribed monotherapy treatment. This is despite a broad evidence
base indicating that, individually, blood pressure medicines are
only modestly effective at reducing blood pressure, even at high
doses, and most patients will require two or more medicines to
achieve control.
As dosage of hypertension drugs is increased, so
too are side effects, which can preclude the use of high doses for
many patients. These side effect challenges, alongside the
management of multiple hypertension medicines being taken together
with treatments for other conditions, can significantly impact
treatment compliance and adherence, including failure to take
medications as prescribed and to persist on long-term therapy.
Ends
References
- World Health Organization Hypertension factsheet
https://www.who.int/news-room/fact-sheets/detail/hypertension
- Lennon MJ, Lam BCP, Lipnicki DM, et al. Use of
Antihypertensives, Blood Pressure, and Estimated Risk of Dementia
in Late Life: An Individual Participant Data
Meta-Analysis. JAMA Netw Open. 2023;6(9):e2333353.
doi:10.1001/jamanetworkopen.2023.33353
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809194
- The Surgeon General’s Call to Action to Control Hypertension
https://www.hhs.gov/sites/default/files/call-to-action-to-control-hypertension.pdf
- Statista Market Insights: Anti-Hypertensive Drugs – United
States
https://www.statista.com/outlook/hmo/pharmaceuticals/anti-hypertensive-drugs/united-states
- Fixed Low-Dose Triple Combination Antihypertensive Medication
vs Usual Care for Blood Pressure Control in Patients With Mild to
Moderate Hypertension in Sri Lanka. A Randomized Clinical Trial
JAMA. 2018;320(6):566-579. doi:10.1001/jama.2018.10359
https://jamanetwork.com/journals/jama/fullarticle/2697010
- 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
https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO
Guideline for the pharmacological treatment of hypertension in
adults
https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf;;
2018 ESC/ESH Clinical Practice Guidelines for the Management of
Arterial Hypertension
https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Arterial-Hypertension-Management-of
About George Medicines George
Medicines is a late-stage biopharmaceutical company addressing
significant unmet need in the treatment of cardiometabolic diseases
with innovative combinations of best-in-class existing treatments,
designed for optimal efficacy and safety.
Combining best-in-class molecules from existing
medicines in novel low-dose formulations, George Medicines is
developing innovative and proprietary treatments to be more
efficacious, safer and accessible than currently available
treatment options. These multi-mechanism, single-pill combinations
offer the potential to bring significant improvements in clinical
outcomes and therapy adherence in patients with cardiometabolic
disorders, including hypertension and diabetes, each of which
remain the leading causes of premature death and disability
worldwide.
The Company’s lead candidate, GMRx2, has
completed a Phase III development program for the treatment of
hypertension, including first-line therapy, and a global trial
focused on the prevention of recurrent intracerebral hemorrhage
(the most severe type of stroke) is underway.
George Medicines is a spin-out company from The
George Institute for Global Health, one of the world’s leading
medical research institutes with a focus on addressing global
health inequity. 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. For more
information, please visit www.george-medicines.com.
Media contacts
ICR Consilium David Daley, Lindsey Neville,
Isabelle Abdou
georgemedicines@consilium-comms.com Tel: +44 (0)
203 709 5700