3 giugno 2021

Dompé Announces Activation of U.S. Clinical Trial Sites for Phase 3 Study of Reparixin, an Oral Investigational CXCR1/CXCR2 Inhibitor, in Hospitalized Patients with Severe COVID-19 Pneumonia

  • Phase 3 REP0220 multicenter clinical trial with 18 sites in the U.S. and Europe underway to determine whether treatment with reparixin, which inhibits the biological activity of IL-8 (CXCL-8), is effective in hospitalized patients with severe COVID-19 pneumonia
  • Phase 2 REPAVID-19 trial results showed reparixin led to better management of respiratory distress when compared to standard of care1



MILAN, Italy and SAN MATEO, Calif., June 4, 2021. –Dompé farmaceutici S.p.A and Dompé U.S. Inc., (collectively Dompé) announced today an update on a pivotal Phase 3 clinical trial evaluating the efficacy and safety of reparixin, a novel CXCR1/CXCR2 inhibitor of the biological activity of IL-8, for the treatment of hospitalized patients with severe COVID-19 pneumonia. The Phase 3 REP0220 trial (NCT04878055) has enrolled more than 50 percent of the planned patients in Europe, and the company has expanded the study to include hospitals in the U.S.

The primary endpoint of the Phase 3 trial is the proportion of patients alive and free of respiratory failure at Day 28. In the study, respiratory failure is defined as use of invasive mechanical ventilation, use of Extracorporeal Membrane Oxygenation (ECMO), or admission to Intensive Care Unit (ICU) linked to worsening of respiratory parameters compared to baseline. Patients will be screened for participation in the trial and randomly assigned (2:1) to receive either reparixin oral tablets (two, 600 mg tablets given three times daily) or matching placebo for up to 21 days, or until decision of discharge from the hospital, on top of standard supportive care.2

“Considering the vast mortality the coronavirus has brought upon the world, we are very encouraged by existing data showing that reparixin had a significant impact on respiratory progression compared to the current standard of care in hospitalized patients with severe COVID-19 pneumonia,” said Marcello Allegretti, Chief Scientific Officer of Dompé. “We look forward to further evaluating reparixin in a larger Phase 3 trial in patients in Europe and the U.S.”

The Phase 3 trial follows the Phase 2 REPAVID-19 clinical trial of reparixin in hospitalized patients with severe COVID-19 pneumonia, (NCT04794803) which achieved its primary endpoint, meeting the pre-specified criteria to begin a phase 3 study.1,3 There were no treatment emergent adverse events determined to be related to the investigational drug in either group. 1

“Based on the pathophysiology of the disease, there is rationale to target the IL-8 pathway in an effort to prevent advancement of respiratory distress in hospitalized patients with COVID-19 pneumonia,” said Dr. Hana Akselrod, Infectious Disease Physician at the George Washington University and an investigator in the Phase 3 study. “Inhibiting IL-8 is a novel approach to treating patients with COVID-19, and we look forward to learning more about whether this mechanism will demonstrate efficacy in this larger, randomized and double-blind clinical trial.”

About Reparixin

Reparixin is an investigational, oral, low-molecular-weight drug that inhibits the action of IL-8 (more recently referred to as CXCL-8)1, one of the inflammatory-signaling proteins thought to be associated with lung injury seen in patients with COVID-19.4 Reparixin inhibits the inflammatory action of IL-8 by binding to two IL-8 receptors, CXCR1 and CXCR2.1Inhibiting IL-8 may be useful in reducing the hyperinflammatory response in patients with severe COVID-19 pneumonia, which otherwise can result in vascular permeability that impedes gas exchange and oxygenation and can be life-threatening.4

Reparixin has previously been investigated by Dompé in a Phase 2 trial for metastatic triple negative breast cancer (FRIDA, NCT02370238), in a Phase 2 trial for patients undergoing single or bilateral lung transplant (REP0104, NCT00224406), and in a Phase 3 trial in patients undergoing pancreatic islet transplantation (REP0211, NCT01817959).

Reparixin is an investigational drug that is not approved for use in any country.

About the Reparixin Clinical Trial Program for Severe COVID-19 Pneumonia

Dompé has initiated a double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of reparixin in the treatment of hospitalized patients with severe COVID-19 pneumonia.

The Phase 3 REP0220 trial (NCT04878055) will enroll approximately 300 patients at 18 centers in Europe and the United States. Patients will be screened for participation in the trial and randomly assigned (2:1) to receive either reparixin oral tablets (two, 600 mg tablets given three times daily) or matching placebo for up to 21 days.2

Reparixin was initially studied in this therapeutic area as part of the REPAVID-19, adaptive Phase 2/3, randomized, controlled multicenter study (NCT04794803) to evaluate the safety and efficacy of reparixin compared to standard of care in adults hospitalized with COVID-19 pneumonia.3The Phase 2 segment of the study included a total of 36 patients randomized to take reparixin orally (two 600 mg tablets, three times daily) with 19 patients in the control arm receiving standard of care. Patients received treatment for up to 21 days, or until discharge from the hospital, whichever came first. 3Upon evaluation of the Phase 2 results, Dompé initiated a separate protocol for its REP0220 Phase 3 trial, and therefore the initial study was terminated with only the Phase 2 segment completed.

For more information on the Phase 3 trial, please visit
https://clinicaltrials.gov/ct2/show/NCT04878055 or contact the Dompe Medical Information at 1-833-366-7387 or USmedinfo@dompe.com.

About Dompé
Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. The R&D department of the company is anchored by EXSCALATE, a structure-based virtual screening platform developed in-house that leverages one of the most powerful supercomputing and artificial intelligence platforms in the world. Today, Dompé employs more than 800 employees worldwide and maintains a U.S. commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston.

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. Data on File. REPAVID-19 Phase 2 CSR. May 2021
  2. https://clinicaltrials.gov/ct2/show/NCT04878055
  3. https://clinicaltrials.gov/ct2/show/NCT04794803
  4. Meizlish ML, Pine AB, Bishai JD, et al. A neutrophil activation signature predicts critical illness and mortality in COVID-19. Blood Adv. 2021;5(5):1164-1177.

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