positive clinical results for Reparixin in a phase 2 trial

In a phase 2 clinical trial, Reparixin reportedly led to better clinical outcomes compared to standard treatment in patients with severe COVID-19 pneumonia. A larger phase 3 clinical study is needed to confirm these results. The results of the phase 2 trial are published in Infectious Diseases and Therapy and were presented at the scientific sessions at the ATS 2022 International Conference in San Francisco, California.

Acute lung injury and acute respiratory distress syndrome (ARDS) are common complications in patients with COVID-19.1 As part of its commitment to invest in meeting unmet medical needs, Dompé conducted an open-label, multicenter study to assess IL inhibition -8 which is known to be associated with the cytokine release syndrome related to coronavirus disease 2019.

“Reparixin is a novel experimental molecule that appears to have novel application in patients with COVID-19-induced acute respiratory inflammation. It was well tolerated in clinical studies,” he said. Giovanni LandoniMD, Director of CARE (Center for Intensive Care and Anesthesiology) at San Raffaele Hospital in Milan, in Italy. “The results against the standard of care may now be reduced by the widespread use of COVID-19 vaccines, but the results indicate that further research in patients with acute respiratory inflammation would be useful. »

Fifty-five patients were randomly assigned in a 2:1 ratio to receive 1200 mg oral Reparixin, an IL-8 inhibitor, three times daily or standard therapy for up to 21 days. The rate of clinical events was significantly lower in the Reparixin group than in the standard treatment group (27% vs. 42.1%, p=0.02). Reparixin treatment was well tolerated in terms of treatment-emergent adverse events, laboratory tests, and vital sign parameters.two.

“Dompé, along with the rest of the biopharmaceutical world, has been working urgently to combat COVID-19 and its complications,” he said. Flavio Mantelli, Dompé’s chief physician. “Although vaccines have helped lessen the severity of the disease, treatment options in hospital for the most severely affected remain limited. We are dedicated to this patient population and look forward to continuing our clinical development program to assess the potential to reduce respiratory complications from COVID-19. »

About the study3

This study was an open-label, multicenter, randomized Phase 2 clinical trial designed to evaluate the efficacy and safety of oral Reparixin in adult patients hospitalized with severe COVID-19-related pneumonia between May 5 2020 and November 27 2020 and published now for the first time. The study involved 55 adults (ages 18 to 90 years) hospitalized with severe COVID-19-like pneumonia, randomized 2:1 to receive Reparixin 1,200 mg orally three times a day or standard therapy ( SOC) for up to 21 days. At least one treatment-related adverse event occurred in 3 patients in the Reparixin group and 5 patients in the SOC group. In general, Reparixin appeared to be well tolerated.

All patients received standard care according to their clinical needs, including medications for COVID-19, according to the local standard treatment of the trial site hospital and according to international guidelines.

please refer to NCT04794803 for additional details about the clinical trial.

About Dompe

Dompé is a private biopharmaceutical company founded in Milan, in Italy, with a 130-year heritage of medical R&D and innovation. Today, Dompé, whose headquarters are in Milanemploys more than 800 people worldwide, with a business operations center in the Bay of San FranciscoIn the U.S.

Forward Looking Statements

This press release refers to certain information that may not be consistent with expected future results. Dompé firmly believes in the validity and reasonableness of the concepts expressed. However, some of this information is subject to a certain degree of uncertainty with respect to its research and development activities and the necessary verifications that must be carried out by regulatory bodies. Consequently, to date, Dompé cannot guarantee that the expected results comply with the information provided above.

References

Tzotzos SJ, et al. critical care. August 21, 2020; 24(1).

2. Multicenter, randomized, controlled, phase 2 study to evaluate the efficacy and safety of reparixin in adult patients hospitalized with pneumonia related to COVID-19, ETA 2022 international conference on San Franciscoin California.

3. https://www.springer.com/journal/40121

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