September 1, 2020

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

The REPAVID-19 clinical trial will evaluate efficacy and safety of Dompé’s Reparixin in hospitalized adult patients with severe COVID-19 pneumonia.
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.
The REPAVID-19 protocol has been authorized by the Italian Medicine Agency (AIFA) in May 2020.

Sept. 1, 2020 - Brazil’s Health Regulatory Agency, ANVISA, has greenlighted Dompé’s REPAVID-19, Clinical Trial of Reparixin for Treatment of Severe Covid-19 Patients.

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, where the immune response may result in vascular permeability that impedes gas exchange and oxygenation. 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 in the states of Sao Paulo, Bahia, Minas Gerais, Santa Catarina and the Federal District (detailed list below). The composite primary endpoint will evaluate patients’ freedom from supportive care based on a pre-defined list of factors. Following successful completion of Phase 2, Dompé has prepared an adaptive trial design that will enable a rapid transition into a pivotal Phase 3 program.

The Phase 3 of Repavid-19 clinical trials, to begin once data from Phase 2 are positively evaluated, will be extended to multiple US centers.

Reference

REPAVID-19 Clinical Study (DDCM) #25351.664925/2020-86.

Brazilian Health Regulatory Agency (Anvisa) http://portal.anvisa.gov.br/english

Diario Oficial da Uniao 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 Geral 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 U.S. commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston.

Forward Looking Statements
This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above.

Medical Affairs Contacts

medical.info@dompe.com

Dompé farmaceutici S.p.A. Single shareholder company / Share capital € 50.000.000,00
REA MI 289519 - A registered company in Milan, Italy / Tax code and VAT number IT00791570153