NMD Pharma Initiates a Combined Phase I/IIa Clinical Trial of NMD670 for the Treatment of Symptoms of Myasthenia Gravis
NMD Pharma Initiates a Combined Phase I/IIa Clinical Trial of NMD670 for the Treatment of Symptoms of Myasthenia Gravis
Aarhus, Denmark, 6 October 2020 - NMD Pharma A/S, a biotech company leading in the development of novel therapeutics for neuromuscular disorders, today announces that the first subject has been dosed in a Phase I/IIa clinical trial of NMD670, NMD Pharma's lead program in development to treat the symptoms of myasthenia gravis (MG). The trial is taking place at the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands under the leadership of Dr Geert Jan Groeneveld, CHDR's Chief Scientific Officer and Chief Medical Officer.
NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. NMD Pharma has demonstrated that ClC-1 inhibition can strengthen neuromuscular transmission and ultimately skeletal muscle function and this novel treatment approach has demonstrated compelling preclinical safety and efficacy data for MG.
The combined Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with MG. The primary outcome includes a number of safety and tolerability endpoints and the secondary outcome, a number of pharmacokinetic endpoints. Further information on the study can be found on the Netherlands Trial Register:
https://www.trialregister.nl/trial/8692
Thomas Holm Pedersen, Chief Executive Office of NMD Pharma, said: "I am pleased to announce that our lead program has entered the clinic. NMD670 has already shown great promise in preclinical studies and we hope that these positive results will be replicated in humans. I would like to thank everyone at NMD for their hard-work and commitment in reaching this important milestone and we look forward to reviewing the top line data next year."
Dr Geert Jan Groeneveld, Chief Scientific Officer and Chief Medical Officer at the CHDR and the Principal Investigator of the trial added: "It is a great privilege to lead this clinical study. Patients with myasthenia gravis suffer from muscle weakness which severely affects their quality of life. Current treatment options for this autoimmune condition are far from optimal so there is a great need to develop and evaluate new therapeutics such as NMD670. For this clinical trial, and in line with its innovative philosophy, CHDR has funded the development and validation of bespoke biomarkers to support the scientific objectives"
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Contacts
NMD Pharma A/S
Thomas Holm Pedersen, CEO
E-mail: contact@nmdpharma.com
Consilium Strategic Communications
Mary-Jane Elliott / Ashley Tapp / Lindsey Neville
E-mail: NMDPharma@consilium-comms.com
Tel: +44 (0)20 3709 5700
About NMD Pharma
NMD Pharma A/S, is a private biotech company leading in the development of novel first-in-class therapies for severe neuromuscular disorders. The Company was incorporated as a spin-off from Aarhus University, Denmark in 2015 and was founded on more than 15 years of muscle physiology research with a focus on regulation of skeletal muscle excitability under physical activity. NMD Pharma has built a world-leading muscle electrophysiology platform leveraging the in-depth know-how of muscle physiology and muscular disorders, small molecule modulators, enabling technologies and tools as well as in-vivo pharmacology models for discovering and developing proprietary modulators of neuromuscular function. NMD Pharma received seed financing from Novo Seeds, Lundbeckfonden Emerge and Capnova in 2016, and in 2018 raised a €38 million Series A financing, led by new investor INKEF Capital, together with new investor Roche Venture Fund and existing investors Novo Seeds and Lundbeckfonden Emerge. Find out more about us online at http://www.nmdpharma.com/.
About NMD670
NMD670 is NMD Pharma's lead development program. It is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. NMD Pharma has demonstrated that ClC-1 inhibition can strengthen neuromuscular transmission and ultimately skeletal muscle function and this novel treatment approach has demonstrated compelling preclinical safety and efficacy data for MG.
About Myasthenia Gravis (MG)
MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles causing debilitating and potentially life-threatening muscle weakness. It most commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing, swallowing and speaking but it can affect most parts of the body. More than 85% of people with MG progress to generalized MG (gMG) within 18 months and in more life-threatening cases, MG can affect the muscles responsible for breathing. Patients with confirmed acetylcholine receptor (AChR) antibodies account for 80-90% of the total gMG population. There are approximately 100,000 people in the European Union, 65,000 people in the United States and 20,000 people in Japan living with the disease.
About the Centre for Human Drug Research
The Centre for Human Drug Research (CHDR) is an independent institute that specialises in cutting-edge early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers helps CHDR maximise their clients' success. CHDR's overall mission is to improve the drug development process by collecting as much information as possible regarding a candidate drug in the early phases of development. This information helps clients make informed decisions regarding the course of clinical development for their product. CHDR places the highest priority on their subjects' comfort and safety, and they play an active role in helping educate the medical and clinical research communities. Find out more about the CHDR online at https://chdr.nl/.
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