Dompé Announces Positive Phase 2 Results for Reparixin in Severe COVID-19 Patients

MilanJune 14, 2022PR Newswire -- Dompé farmaceutici S.p.A. ("Dompé") today announced the results of a Phase 2 clinical trial indicating that Reparixin improved clinical outcomes compared to standard of care in critically ill COVID-19 patients. The findings require confirmation through a larger Phase 3 clinical study. The results of the Phase 2 trial were published in《Epidemics and Treatment》（Infectious Diseases and Therapy）The journal, and presented at the scientific session of the American Thoracic Society (ATS) 2022 International Conference in San Francisco, California.

Acute lung injury and acute respiratory distress syndrome (ARDS) are common complications in patients with COVID-19.¹Dompé Farmaceutici S.p.A. is committed to investing in relevant research to address unmet medical needs and has conducted an open-label, multi-center study to evaluate the inhibitory effect of IL-8, which is known to be associated with COVID-19-related cytokine release syndrome.

Dr. Giovanni Landoni, Director of the Center for Advanced Research in Intensive Care and Vascular Medicine (CARE) at San Raffaele Hospital in Milan, Italy, stated: "Reparixin is a new experimental molecule that appears to have novel utility for patients with acute respiratory inflammation caused by COVID-19. It has shown good tolerability in clinical studies. Although the number of results comparing it with standard care may have decreased due to the widespread use of COVID-19 vaccines, the results obtained so far indicate that continuing related research is valuable for patients with acute respiratory inflammation."

Fifty-five patients were randomly grouped in a 2:1 ratio to receive either oral Reparixin (an IL-8 inhibitor) at a dose of 1200 mg three times daily or standard care for up to 21 days. Compared with the standard care group, the incidence of clinical events in the Reparixin group showed a statistically significant reduction (27% vs. 42.1%, p=0.02). In terms of treatment-emergent adverse events, laboratory tests, and vital sign parameters, Reparixin was well-tolerated.²。

Dompé Chief Medical Officer Flavio Mantelli stated: "Dompé, along with other parties in the biopharmaceutical community, is making urgent efforts to combat COVID-19 and its complications. While vaccines help reduce the severity of the disease, options remain limited for the most severely affected patients when hospitalized. We are committed to aiding this patient population and look forward to continuing to advance our clinical development program to assess the potential for reducing respiratory complications from COVID-19."

AboutThis study ³ 

This study is an open-label, multi-center, randomized Phase 2 clinical trial designed to evaluate the efficacy and safety of oral Reparixin in critically ill adult patients with COVID-19 who were hospitalized between May 5, 2020, and November 27, 2020. The relevant details of this study are now being released for the first time. The study enrolled 55 critically ill adult patients (aged 18-90) hospitalized for COVID-19, randomly assigned in a 2:1 ratio to receive either oral Reparixin at 1200 mg three times daily or standard of care (SOC), for a treatment period of 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 demonstrated good tolerability.

According to the local standard treatment protocols of the hospitals where the trial was conducted and international guidelines, all patients received standard treatment based on their clinical needs, including COVID-19 medication.

For more details about the clinical trial, please refer toNCT04794803。

AboutDompé 

Dompé is a privately-held biopharmaceutical company founded in Milan, Italy, with 130 years of history in research, development, and medical innovation. Today, Dompé, headquartered in Milan, employs over 800 people worldwide and operates a commercial hub in the San Francisco Bay Area in the United States.

ProspectiveStatement 

Certain information contained in this press release may not align with anticipated future results. Dompé firmly believes in the accuracy and reasonableness of the stated concepts. However, due to the inherent uncertainties associated with its research and development activities and the necessary reviews by regulatory authorities, some degree of uncertainty exists regarding this information. Therefore, at present, Dompé cannot guarantee that the anticipated outcomes will match the information provided above.

References 

1. Tzotzos SJ, et al. Crit Care. 2020 Aug 21;24(1).

2. A Phase 2 Multicenter Randomized Controlled Study Evaluating the Efficacy and Safety of Reparixin in Hospitalized Adult Patients with COVID-19, 2022 American Thoracic Society (ATS) International Conference, San Francisco, California.

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