Dompé Announces Results of Phase 2 Study Evaluating the Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia

• In hospitalized patients with COVID-19 Pneumonia, the rates of clinical events among those treated with Reparixin (n=36) were statistically significantly lower than standard of care (n=19).
• The study is the first evaluation of the efficacy and safety of Reparixin an IL-8 inhibitor in patients with severe COVID-19 pneumonia.
• Results from the Phase 2 trial were presented at the American Thoracic Society (ATS) 2022 International Conference and published in Infectious Diseases and Therapy

MILAN, June 13, 2022 /PRNewswire/ -- Dompé farmaceutici S.p.A ("Dompé") today announced results from its Phase 2 clinical trial demonstrating that, in patients in severe COVID-19 Pneumonia, Reparixin led to an improvement in clinical outcomes when compared with the standard of care, a larger phase 3 clinical study is needed to confirm these results. Results from the Phase 2 trial are published in Infectious Diseases and Therapy and were 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 research for unmet medical needs, Dompé conducted an open-label, multi-center study to evaluate the inhibition of IL-8 which is known to be associated with cytokine release syndrome connected to Covid-19 disease.

"Reparixin is a new investigational molecule that seems to have a novel application in patients with acute respiratory inflammation induced by COVID-19. It was well tolerated in clinical studies," said Giovanni Landoni, MD, Director of CARE (Center for Intensive Care and Anesthesiology) at Hospital San Raffaele in Milan, Italy. "The outcomes as compared to the standard of care may now be reduced by the widespread use of COVID-19 vaccines, but the obtained results indicated continued investigation would be valuable in patients with acute respiratory inflammation."

Fifty-five patients were randomized 2:1 to receive 1200 mg of oral Reparixin, an inhibitor of IL-8, three times daily or the standard of care for up to 21 days. The rate of clinical events was statistically significantly lower in the Reparixin group compared to those assigned to the group receiving standard of care (27% vs. 42.1%, p=0.02). Treatment with Reparixin was well-tolerated in terms of treatment-emergent adverse events, laboratory test and vital sign parameters².

"Dompé, along with the rest of the biopharmaceutical world, has worked with urgency to fight COVID-19 and its complications," said Flavio Mantelli, Chief Medical Officer at Dompé. "While vaccines have helped to mitigate severity of disease, in-hospital treatment options for those who are most seriously impacted remain limited. We are dedicated to this patient population, we are looking forward to continuing our clinical development program to evaluate the potential to reduce COVID-19 respiratory complications."

About the Study³

The study was an open-label, multicenter, randomized, phase 2 clinical trial designed to assess the efficacy and safety of oral Reparixin in adult patients hospitalized with severe COVID-19 pneumonia from May 5, 2020, until November 27, 2020 and now released for the first time. The study enrolled 55 adults (aged 18–90 years old) hospitalized with severe COVID-19 pneumonia, assigned randomly 2:1 to receive 1200mg Reparixin orally three times daily or standard of care (SOC) for up to 21 days. At least one treatment emergent adverse event occurred in 3 patients in the Reparixin group, and 5 patients in SOC. Reparixin overall appeared to be well tolerated.

All patients received the standard care based on their clinical need, including COVID-19 medications, as per local standard therapy at the trial site hospital and in line with international guidelines.

Please refer to NCT04794803 for additional clinical trial details.

About Dompé

Dompé is a privately-held biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of R&D and medical innovation. Today, Dompé, with Headquarters in Milan, employs more than 800 employees worldwide, with a commercial operations hub in the San Francisco Bay Area, U.S.

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.

References

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

2. A phase 2 multicenter, randomized, controlled study to evaluate the efficacy and safety of Reparixin in hospitalized adult patients with COVID-19 pneumonia, ATS 2022 International Conference in San Francisco, California.

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

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