Marinomed Biotech AG enrolls first patient in clinical study of inhaled Carragelose to treat COVID-19 infections
Marinomed Biotech AG (VSE:MARI), an Austrian science-based biotech company with globally marketed therapeutics derived from innovative proprietary technology platforms, announced today that the first patient has been treated in a clinical trial evaluating Inhaleen, a Carragelose-based inhalation solution, in hospitalized patients with COVID-19.
The study will evaluate safety and efficacy of inhaled Carragelose for the treatment of moderate COVID-19, i. e. patients with respiratory COVID-19 symptoms who require hospitalization but not intensive care. The randomized, double-blind, placebo-controlled trial will recruit 204 recently hospitalized patients with confirmed COVID-19 who will be randomized less than 48 hours after admission to the hospital. Patients will inhale 3 times a day for 7 minutes with either Inhaleen (1.2 mg/ml Carragelose; total dose iota-carrageenan per day: 5.05 mg) or a placebo control for 5 days.
As primary endpoint, the trial aims to demonstrate that Inhaleen inhalation improves the clinical status of hospitalized patients on day 8 compared to placebo. The clinical status will be documented according to the WHO-8-Category scale, which ranges from 1 (not hospitalized, no limitation of activities) to 8 (death). Secondary endpoints include the number of patients requiring critical care support, supplemental oxygen requirement, and PCR diagnosis of SARS-CoV-2 or other respiratory viruses. The latter is designed to evaluate efficacy of Inhaleen against viral pneumonias caused by viruses other than SARS-CoV-2.
The trial will be conducted at three hospitals based in Vienna, Austria. Dr. Arschang Valipour, Head of Internal Medicine and Pneumology at the Vienna-based hospital Klinik Floridsdorf, will lead the clinical trial program. If Inhaleen is proven safe and effective for the treatment of COVID-19 in hospitalized patients, Marinomed plans to use the clinical trial results to seek certification for the inhaled Carragelose formulation from the relevant authorities.
“We still see a very high medical need for effective therapies against COVID-19. Currently, doctors have only limited treatment options beyond supportive care and cannot help much while a patient’s condition is deteriorating,” said Dr. Eva Prieschl-Grassauer, Chief Scientific Officer at Marinomed. “With this trial of inhaled Carragelose, we hope to show that Inhaleen can be an effective treatment for recently hospitalized patients with COVID-19. Additionally, we intend to show that Inhaleen can aid faster recovery and prevent the disease from further damaging a patients’ lungs or progressing to more severe stages,” Dr. Prieschl-Grassauer, added. “We have done comprehensive preclinical work showing the efficacy of Carragelose against SARS-CoV-2. Together with the recent clinical results, which showed that iota-carrageenan can be effectively used for COVID-19 prophylaxis, we are very confident that Inhaleen will be an effective treatment for COVID-19 patients.”
A clinical trial of Carragelose-based nasal spray recently showed high efficacy in the prevention of COVID-19 in hospital workers with an 80 % reduction in cases. The independent investigator-initiated study was conducted in Argentina with an iota-carrageenan nasal spray identical to Marinomed’s Carragelose nasal spray, which is marketed as an antiviral OTC product in many countries[1] and already approved for the treatment and prevention of several other viral respiratory diseases, including endemic Coronaviruses.
About Carragelose®:
Carragelose® is a sulfated polymer from red seaweed and is a unique, broadly active anti-viral compound. It is known as a gentle yet effective and safe prevention and treatment against respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a layer on the mucosa wrapping entering viruses, thereby inactivating them, and preventing them from infecting cells. Increasing clinical evidence indicates that Carragelose® can also inactivate SARS-CoV-2.[2] Marinomed is holder of the IP rights and has licensed Carragelose® for marketing in Europe, parts of Asia, Canada, and Australia. For a full list of Marinomed’s portfolio of Carragelose® containing nasal sprays and oral products, please visit https://www.carragelose.com/en/portfolio/launched-products, for a list of scientific publications on Carragelose®, https://www.carragelose.com/en/publications.
About Marinomed Biotech AG
Marinomed Biotech AG (Korneuburg, Austria) is an Austrian science-based biotech company with globally marketed therapeutics listed on the Prime Market of the Vienna Stock Exchange. The company focuses on the development of innovative products based on two patent-protected technology platforms. The Marinosolv® technology platform increases the efficacy of hardly soluble compounds for the treatment of sensitive tissues such as eyes, nose, lung or gastrointestinal tract. The Carragelose® platform comprises innovative patent-protected products for the prophylaxis und treatment of respiratory tract viral infections including SARS-CoV-2. Carragelose® is used in nasal sprays, throat sprays and lozenges, which are sold via international partners in over 40 countries worldwide. Marinomed®, Marinosolv® und Carragelose® are registered trademarks of Marinomed AG. These trademarks may be owned or licensed in select locations only. Further information is available at https://www.marinomed.com/en/technologies-markets/markets.
[1] https://www.carragelose.com/en/portfolio/launched-products
[2] https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1
For further inquiries contact:
Dr. Eva Prieschl-Grassauer
Chief Scientific Officer, Marinomed Biotech AG
Hovengasse 25, 2100 Korneuburg, Austria
T +43 2262 90300
E-mail: eva.prieschl@marinomed.com
http://www.marinomed.com/en
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E-mail: marinomed@mc-services.eu
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