1. Company Business Profile
PHARMENA was established as a result of a discovery made by the scientists of Lodz University of Technology who discovered the possibility to use particular pyridinium salts in medicine. The Company was founded in order to commercialize the above invention. There are many possible applications of those active ingredients in various areas of medicine. Currently, the Company`s activity focuses on two areas:
- Research in the USA and Canada on the application of selected pyridinium salts in medicine in order to develop a drug that is innovative on a global scale;
- Marketing of innovative dietary supplements based on a patented molecule.
- Development and implementation of an innovative medical device.
2. Research and Development
1‑MNA is a unique, patented molecule capable of acting on inflammatory markers and providing additional therapeutic benefits. PHARMENA has also been researching possible therapeutic applications of 1‑MNA as an anti-inflammatory and anti-fibrotic drug. Clinical studies conducted so far have demonstrated high safety and tolerance of 1-MNA.
Based on the preclinical and early clinical trials, potential therapeutic indications for 1-MNA include pulmonary fibrosis, respiratory tract diseases (such as pneumonia, bronchitis, asthma, Sars-CoV-2 infection) inflammatory diseases, such as non‑alcoholic steatohepatitis (NASH) and pulmonary arterial hypertension (PAH), dyslipidemia, atherosclerosis, cardiac infarction. In phase 2 clinical studies 1-MNA showed a capacity to affect inflammatory biomarkers (e.g. TNFα). 1-MNA reduced TNFα in a statistically significant manner, which may make it an effective therapy for patients with viral infections, including COVID-19. A high TNFα level is associated with an increased risk of severe course of the disease and an increased risk of death in patients with coronavirus. At the same time, in some respiratory tract diseases, including viral infections, a reduced endogenous 1-MNA level is observed. Additionally, by demonstrating its unique capacity to stimulate endogenous prostacyclin (PGI2) production, 1-MNA shows antithrombotic effects and improves the functioning of the endothelium.
Preclinical studies conducted by the Company have shown that 1-MNA has anti-inflammatory and anti-fibrotic effects. In an animal model of pulmonary fibrosis, 1-MNA reduced pulmonary fibrosis, showing higher effectiveness than reference drugs in the study, used currently on the market, i.e. nintedanib and fluticasone.
Based on the above findings, the Company has developed a 1-MNA research plan for respiratory tract infections, including those induced by Sars-Cov-2. The Company intends to present the study results to the pharmaceutical industry with the purpose of further commercialisation of 1-MNA as a drug candidate in the above indications.
Furthermore, the Company continues works on the commercialisation of 1-MNA in non‑alcoholic steatohepatitis (NASH) and pulmonary arterial hypertension (PAH).
At the same time, when it comes to reducing the risk of cardiovascular events, the Company has achieved positive results of the phase 2 clinical trials, which gives the green light for the further work on the project.
Currently, Pharmena holds a dominant position in the area of intellectual property protection for therapeutic applications of 1-MNA and holds marketing authorization applications both in the USA and Canada.
3. Markets
PHARMENA SA is taking measures to increase the sale of its products in Europe and worldwide. Furthermore, research and development aimed at pulmonary fibrosis, respiratory tract infections, including viral infections (also COVID-19), inflammatory diseases, metabolic diseases and other therapeutic applications, if successful, can lead to new drugs sold on all major markets. In 2018, PHARMENA registered 1‑MNA as “novel food” in the European Union and launched dietary supplement based on this innovative molecule.