“Grindeks” has successfully completed the Phase 1 Clinical Study of Its New Investigational Medicinal Product Methyl-GBB
JSC “Grindeks” announces that it has completed the Phase 1 clinical study of its new investigational medicinal product metyl-GBB. This new investigational medicinal product is intended for the treatment of cardiovascular diseases. This treatment will have a unique therapeutic advantage – the new medicine will be available in both parenteral and oral dosage forms.
Preclinical studies have demonstrated the efficacy of the new molecule in reducing heart infarct size as a result of mitochondrial protection, attenuation of atherosclerosis progression and improving glucose metabolism. Preclinical and clinical Phase 1 studies show a very good safety profile of the investigational medicinal product.
Chairman of the Board of JSC “Grindeks” Ph. D, Juris Hmelnickis: “This significant project confirms the readiness of “Grindeks” to offer patients innovative medicines for the treatment of myocardial infarction and coronary heart disease in the near future. In addition, this will prove the research capacity of Latvian scientists, as it will be the first new original medicine invented in Latvia and developed by a Latvian company since the 1980s.”
Phase 1 clinical study was conducted in collaboration with internationally renowned researchers, scientific consultants and contract research organizations in accordance with the “Good Clinical Practice” (ICH / GCP) and European Union regulatory requirements for Phase I - IV clinical trials. Researchers of the Latvian Institute of Organic Synthesis in cooperation with JSC “Grindeks” previously carried out the chemical and experimental research of the new molecule.
Based on these results, JSC “Grindeks” plans to initiate phase II clinical studies. In order to implement the ambitious project, JSC “Grindeks” is currently seeking a strategic partner within the pharmaceutical industry.
Cardiovascular diseases are the leading cause of death in Latvia and worldwide. An estimated 31% of all global deaths were caused by cardiovascular diseases in 2016. Of these deaths, about 85% are due to heart attacks and stroke, and one third of these deaths occur prematurely in people under 70 years of age.
Diabetes and atherosclerosis are the major risk factors for cardiovascular diseases. According to the World Health Organization, there were 463 million people in the world diagnosed with diabetes in 2019. The number of patients with the disease is expected to reach 700 million by 2045.
“Grindeks” is an international pharmaceutical company focused on research, development, manufacturing and sales of original products, generics and active pharmaceutical ingredients. The Group of “Grindeks” has four subsidiary companies in Latvia, Estonia, and Slovakia as well as representative offices in 11 countries.
“Grindeks” specializes in the heart and cardiovascular, CNS, anti-cancer and gastroenterological medication therapeutic groups. A range of products covers a combination of original products Mildronate® (meldonium) and Ftorafur® (tegafur), generics, food supplements and active pharmaceutical ingredients.
In 2019, products of the company were exported to 84 countries. The most significant “Grindeks” markets include the EU countries, Russia and the other CIS countries, the USA, Canada and Japan.
Head of the Communications Department, JSC “Grindeks”
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