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Tuesday, June 14 2022 - 00:05
Dompe Announces Results of Phase 2 Study Evaluating the Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia
MILAN, June 13, 2022, /PRNewswire-AsiaNet/ --

- 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

Dompe farmaceutici S.p.A ("Dompe") 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, Dompe 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 

"Dompe, 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 Dompe. "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 Dompe

Dompe is a privately-held biopharmaceutical company founded in Milan, Italy, 
with a 130-year legacy of R&D and medical innovation. Today, Dompe, 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. Dompe 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, Dompe cannot guarantee that the 
expected results will be consistent with the information provided above.


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.


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SOURCE: Dompe farmaceutici S.p.A