PR96481

MILAN, June 13, 2022, /PRNewswire=KYODO JBN/ --

- 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

parameters2.

"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 [

https://clinicaltrials.gov/ct2/show/NCT04794803?term=reparixin&draw=1&rank=2 ]

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.

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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SOURCE: Dompe farmaceutici S.p.A