COVID-19 - Brazilian Health Regulatory Agency (ANVISA) authorizes Dompé's REPAVID-19, a Phase 2 Clinical Trial for Treatment of Severe Patients

10 Brazilian centers in São Paulo, Brasilia, Presidente Prudente, Sao José do Rio Preto, Varginha, Salvador de Bahia, Criciùma

The Phase 3 clinical study will be enlarged to the US

MILAN, Sept. 2, 2020 /PRNewswire/ -- Brazil's Health Regulatory Agency, ANVISA, has greenlighted Dompé's REPAVID-19, Clinical Trial of Reparixin for Treatment of Severe Covid-19 Patients.

https://mma.prnewswire.com/media/1190715/Dompe_Logo.jpg [https://mma.prnewswire.com/media/1190715/Dompe_Logo.jpg]

Reparixin inhibits the action of interleukin 8 (IL-8), one of the inflammatory signaling proteins that is thought to be associated with the lung injury seen in patients with SARS-CoV2 infection. Consequently, this action is aimed to be useful in the treatment of COVID-19 pneumonia patients. The treatment is based on Reparixin oral tablets 1200 mg TID till 21 days, in case of confirmed improvement after 7 days.

REPAVID-19 will enroll 48 for Phase 2, 111 for Phase 3 with severe COVID-19 pneumonia randomized 2:1 in the Phase 2, and the results will inform the study design for the Phase 3. The study involves a minimum of 10 Brazilian centers. Following successful completion of Phase 2, Dompé has prepared a rapid transition into a Phase 3 program, to begin once data from Phase 2 are positively evaluated, and to be extended to multiple US centers.

References REPAVID-19 Clinical Study (DDCM) #25351.664925/2020-86 Brazilian Health Regulatory Agency (ANVISA) http://portal.anvisa.gov.br/english [http://portal.anvisa.gov.br/english] Diário Oficial da União http://www.in.gov.br/autenticidade.html [http://www.in.gov.br/autenticidade.html]

Repavid-19 sites list (City, State)

São Paulo (São Paulo) - Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo - Hospital Vila Nova Star

Presidente Prudente (São Paulo) - Santa Casa de Misericórdia de Presidente Prudente

Sao José do Rio Preto (São Paulo) - Faculdade de Medicina de São José do Rio Preto

Varginha (Minas Gerais) - Hospital Humanitas

Salvador (Bahia) - Hospital da Cidade - Hospital General Ernesto Simões Filho- SESAB - Hospital São Rafael. Rede D'or São Luiz

Brasilia (Distrito Federal) - Instituto D'or Pesquisa e Ensino

Criciùma (Santa Catarina) - Sociedade Literária e Caritativa Santo Agostinho - Hospital São José

About Dompé Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy. Today, Dompé employs more than 800 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston.

Medical Affairs Contacts: medical.info@dompe.com [mailto:medinfo@dompe.com]

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CONTACT: Guido Romeo, mobile: +39 342 1239414, guido.romeo@dompe.com

Web site: https://www.dompe.com/

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