positive clinical results for Reparixin in a phase 2 study

In a phase 2 clinical trial, Reparixin reportedly resulted in improved clinical outcomes compared to standard of care in patients with severe COVID-19 pneumonia. A larger phase 3 clinical trial is required to confirm these results. Phase 2 study results will be published in Infectious Diseases and Therapy and presented at the scientific sessions of 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 finding unmet medical needs, Dompé conducted an open-label and multi-center study to evaluate IL-8 inhibition It is known to be associated with cytokine release syndrome associated with 2019 coronavirus disease.

“Reparixin is a novel experimental molecule that appears to have novel application in patients with COVID-19-induced acute airway inflammation. It’s been well tolerated in clinical trials,” he said John LandoniMD, Director of CARE (Center for Critical Care and Anesthesiology) at San Raffaele Hospital in Milan, in Italy. “Outcomes compared to standard of care may now be reduced by the widespread use of COVID-19 vaccines, but the results suggest that further research in patients with acute airway inflammation would be beneficial.” »

Fifty-five patients were randomized in a 2:1 ratio to receive oral Reparixin, an IL-8 inhibitor, 1200 mg three times a day or standard therapy for up to 21 days. The rate of clinical events was significantly lower in the Reparixin group than in the standard of care group (27% vs. 42.1%, p=0.02). Treatment with Reparixin was well tolerated in terms of treatment-emergent adverse events, laboratory tests, and vital signs2.

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

About the study3

This study was an open-label, multi-center, randomized, Phase 2 clinical trial evaluating the efficacy and safety of oral Reparixin in adult patients hospitalized between May 5th with severe COVID-19-related pneumonia 2020 and 11/27 2020 and now published for the first time. The study enrolled 55 adults (aged 18 to 90 years) hospitalized with severe COVID-19-like pneumonia who were randomized in a 2:1 ratio to receive Reparixin 1200 mg orally three times a day or standard care ( SOC) received for up to 21 days. At least one treatment-emergent adverse event occurred in 3 patients in the Reparixin group and 5 patients in the SOC group. Overall, Reparixin appeared to be well tolerated.

All patients received standard of care according to their clinical needs, including COVID-19 medication, according to the local standard of care of the hospital at the study site and in accordance with international guidelines.

Please refer to NCT04794803 for more details on the clinical study.

About dome

Dompé is a private biopharmaceutical company founded in Milan, in Italy, with a 130-year tradition in R&D and medical innovation. Today Dompé is headquartered in Milanemploys more than 800 people worldwide and has a business operations center in the Bay of san franciscoin the USA.

Forward-Looking Statements

This press release contains certain information that may not be consistent with anticipated future results. Dompé firmly believes in the validity and appropriateness of the concepts expressed. However, some of this information is subject to a certain degree of vagueness in relation to their research and development activities and the necessary verifications that must be carried out by regulatory authorities. Consequently, to date, Dompé cannot guarantee that the expected results will be consistent with the information presented above.

references

1. Tzotzos SJ, et al. intensive care. Aug 21, 2020; 24(1).

2. Multi-center, randomized, controlled, phase 2 study to evaluate the efficacy and safety of Reparixin in adult hospitalized patients with COVID-19-related pneumonia, ATS 2022 International conference on san franciscoin California.

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

Leave a Comment