12 maggio 2020

AIFA Announces Italian Authorization of Phase 2/3 Clinical Trial of Reparixin for the Treatment of Severe Patients with COVID-19 Pneumonia

AIFA, the Italian Medicines Agency, has authorized the initiation of a multicenter, randomized, controlled study of Reparixin, a novel investigational low-molecular-weight CXCR1/CXCR2 receptor inhibitor developed by Dompé.

The Italian Medicines Agency (AIFA) authorized the commencement of a Phase 2/3 clinical study in Italy, titled REPAVID-19, to evaluate efficacy and safety of Reparixin in hospitalized adult patients with severe COVID-19 pneumonia.

REPAVID-19 will enroll 48 patients 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 has already begun enrolling patients at San Raffaele Hospital in Milan and includes additional hospitals in Italy. 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. Reparixin will be administered as oral tablets in Phase 2/3 and will also be available as a continuous IV infusion in the subsequent study.

Reparixin has previously been investigated by Dompé in a Phase 2 trial for metastatic triple negative breast cancer (FRIDA, NCT02370238), in a Phase 2 trial for patients undergoing single or bilateral lung transplant (Study REP0104), and in a Phase 3 (REP0211 NCT01817959) in patients undergoing pancreatic islet transplantation.

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 potentially useful in the treatment of COVID-19 pneumonia patients, where the immune response may result in vascular permeability that impedes gas exchange and oxygenation.

Physicians can contact Dompé US Medical Information for further details at 1-978-435-6942 or USmedinfo@dompe.com.

Reference

https://www.aifa.gov.it/documents/20142/1131319/REPAVID19_documenti.zip/e666c1b7-66c0-d77a-282e-924d7c59943b

About Dompé
Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. 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.

For the United States:

Randi Kahn

+1 631 697 8310

Randi.Kahn@syneoshealth.com

For Europe:

Stefano Amoroso

+39 340 2838136

Stefano.Amoroso@dompe.com

Guido Romeo

+39 349 4154010

Guido.romeo@

dompe.com

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