The IGTP coordinates a clinical trial to reduce the number of infections by SARS-CoV-2
The Germans Trias i Pujol Research Institute (IGTP) is coordinating a clinical trial to test whether the food supplement Manremyc® can prevent infections by SARS-CoV-2. Manremyc® is a food supplement administered in a course of 14 oral capsules containing bacilli of heat inactivated Mycobacterium s. manresensis, which could reduce the number of infections by SARS-CoV-2; or, in the case of infection, reduce the severity of the disease. The sponsor of the study is Reig Jofre, which has licensed the distribution of the supplement in the European Union, and it is coordinated by the IGTP. The study will be carried out in collaboration with the Foundation University Institute for Primary Health Care Research Jordi Gol i Gurina (IDIAPJGol).
Manremyc® is the fruit of research and development carried out for more than 10 years by the Experimental Tuberculosis Unit at the IGTP, led by Dr Pere-Joan Cardona. Its mechanism of action is based on research into the progression from infection by Mycobacterium tuberculosis to development of tuberculosis (TB) in which they discovered that the disease was the result of an excessive inflammatory response against M. tuberculosis. The administration of Manremyc® generates a balanced immune response, with a large proportion of memory regulatory T cells, which prevent inflammation and lesions in the lungs. Recently, several researchers have observed that countries where there is massive BCG vaccination (Bacillus Calmette-Guérin vaccine) against TB have a lower incidence of COVID-19.
"This is due to the stimulation of the innate immune response by this vaccine. Manremyc® has the same effect and additionally it generates an anti-inflammatory response in the lungs," explains Dr Cardona.
The scientific evidence suggests that Manremyc® could help to prevent an infection with SARS-CoV-2 developing into a serious lung infection, due to the similarity in action of the two diseases. The trial will concentrate on studying the protection of professionals working in health care centres because of their very high level of exposure to the virus that causes COVID-19. If a protective effect for Manremyc® is demonstrated, its use could easily be generalized, as the treatment regime is easy to follow (one tablet every day for 14 days) and it is well tolerated. Results are expected in October 2020.
The trial will start this May, led by Dr Pere-Joan Cardona from the IGTP together with the Foundation University Institute for Primary Health Care Research Jordi Gol i Gurina (IDIAPJGol). It will be carried out in the Germans Trias I Pujol Hospital and several primary health care centres in the Northern and Southern Metropolitan Territories of Barcelona. It is a placebo controlled double blind clinical trial to evaluate the efficacy of the treatment for health professionals who have a high risk of contracting COVID-19.
Manremyc® has been developed by a spin-off company of the IGTP (Manresana de Micobacteriologia, s.l.). The IGTP has led its clinical development, completing two safety and immunological clinical trials at the Germans Trias I Pujol Hospital and with two efficacy studies in progress; one in Tblisi, Geòrgia, where 14000 volunteers have been recruited, and the other in Cape Town, South Africa.
About Reig Jofre
Founded in 1929 in Barcelona, Reig Jofre is a family run pharmaceutical company; it is listed on the Spanish Continuous Stock Exchange and dedicated to the research, development, manufacture and commercialization of pharmaceutical products and food supplements. It has four plants in Toledo (2), Barcelona and Malmo (Sweden). Reig Jofre organizes its activities in three areas of business: 1) Pharmaceutical technology specialized in sterile injectables and lyophilized products, and antibiotics derived from penicillin; 2) Specialty Pharmacare in dermatology, osteoarticular health and women's heath (in.house development and production) and 3) consumer healthcare products mainly under the brand Forté Pharma, mostly in France, Belgium, Spain and Portugal and other over-the-counter products.
Reig Jofre has over 1000 employees, direct sales in 7 countries and more than 130 commercial partners in 72 countries of the world. The company closed 2019 with a turnover of over 200 million euros.