Pharmamar stalls the development of its final study of Aplidin against him Covid-19 due to the poor evolution of hospital recruitment in Latin America.
Centers closed for testing in the region remain unchanged for more than two months, according to the update made this week by the biopharmaceutical in the technical file of the trial registered in the FDA U.S.
6 of the 14 countries in which Pharmamar looks for patients belong to Latin America and the figures do not accompany them. The biopharmaceutical continues without closing any of the 4 hospitals planned to Peru.
Pharmamar asked the region for help
Argentina and Brazil they provide a hospital center of the 7 and 8 raised respectively and in Mexico and Colombia the figure is still 3 out of 6 possible in both countries.
Pharmamar’s objective is for Latin America to become a fundamental region for Neptuno, as phase three of Aplidin against coronavirus is known, come to fruition.
The president of the group of Galician origin, Jose Maria Fernandez Sousa, asked Latin American countries for help to join Neptune and thus complete the study.
“The collaboration of the countries of the region is key and I ask for your help to complete Neptune”Declared Fernández Sousa at an Ibero-American scientific congress held in October.
75 percent of Spanish hospitals are recruited
The reasons for requesting help are that Aplidin is indicated for hospitalized patients with moderate symptoms and the virulence of Covid-19 in these countries is higher than that registered in Europe, which increases hospitalizations.
The study situation is more favorable in Europe thanks to Spain, France and Romania. Pharmamar has recruited 75 percent of the hospitals that will be part of the study in Spain.
Spain is the country that will contribute the most hospitals to the study and Pharmamar is waiting to close the less than 10 hospitals that remain and that are distributed among the Madrid’s community, Galicia, Castilla la Mancha, Castile and Leon and Andalusia.
All work ahead in 4 countries
France was the first country where Pharmamar managed to sign the three chosen hospitals and after the success it opened the objective to one more hospital, still to be completed, while in Romania the confirmed centers amount to 6 out of 7 possible.
Despite this, Pharmamar still has work ahead in Greece, Turkey, and Portugal to add hospitals. Outside the Old Continent, no center of the 3 planned for South Africa.
The new wave of coronavirus in Europe may become an opportunity to speed up the study, sources close to the trial acknowledge, but the worst incidence and hospitalization data are occurring in Austria O Germany, where Pharmamar will not perform Neptune.
Pharmamar is aware of the little impact on results
The latest update of the datasheet also shows that the study end date remains unchanged and the study would be completed in March 2022. A date that suffered a delay of six months with respect to the initial approach of the company.
Pharmamar is aware that the slow evolution of Neptuno causes the impact of Aplidin on the income statement to be practically nullified by the control of the pandemic, the efficacy of vaccines and the arrival on the market of antivirals from pharmaceutical companies such as Pfizer and Merck.
The company sources consulted are not concerned about a fact “that is already discounting” and they insist that a satisfactory “result” will be seen. This result “will serve to verify the potency of Aplidin as an antiviral”.