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Posted On: 06/09/2020 12:27:41 PM
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HAMILTON, Bermuda, June 08, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced the presentation of 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation at the European E-Congress of Rheumatology (EULAR) 2020. The company also announced an active investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for its global placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation. Additionally, an investigator-initiated placebo-controlled study in the U.S. is enrolling patients.
On Saturday, June 6, 2020, at EULAR 2020, Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy, delivered 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab in non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation. The presentation, entitled Mavrilimumab Improves Outcomes in Severe COVID-19 Pneumonia and Systemic Hyper-Inflammation, is available through the Science section of Kiniksa’s website (www.kiniksa.com).
In the treatment protocol, 13 non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation were treated with a single intravenous dose of mavrilimumab 6 mg/kg upon admission to the hospital. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar baseline characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control-group. All patients received similar standard of care therapy, including antivirals and antibiotics.
Over the course of the 28-day follow-up period, mavrilimumab-treated patients experienced earlier and improved clinical outcomes than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations, and no deaths.
Death occurred in 0% (n=0/13) of mavrilimumab-treated patients by Day 28, compared to 27% (n=7/26) of control-group patients (p=0.086).
8% (n=1/13) of mavrilimumab-treated patients progressed to mechanical ventilation by Day 28, compared to 35% (n=9/26) of control-group patients who progressed to mechanical ventilation or died (p=0.077).
100% (n=13/13) of mavrilimumab-treated patients and 65% (n=17/26) of control-group patients attained the clinical improvement endpoint (defined as improvement of ≥ 2 categories on a 7-point scale for assessment of clinical status) by Day 28 (p=0.0001).
Fever resolved in 91% (n=10/11 febrile patients) of mavrilimumab-treated patients by Day 14, compared to 61% (n=11/18 febrile patients) of control-group patients (p=0.0093).
Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status.
P-values above are unadjusted for multiplicity. Mavrilimumab was well-tolerated in all patients, without infusion reactions.
“The 28-day clinical outcomes data from the treatment protocol with mavrilimumab in COVID-19 pneumonia and hyperinflammation are consistent with the recently-reported 14-day dataset,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “Mavrilimumab-treated patients showed earlier and improved clinical outcomes compared to matched contemporaneous control-group patients throughout the protocol. These data are encouraging, and we look forward to evaluating mavrilimumab further in this patient population through placebo-controlled studies. To this end, we are pleased to announce the active U.S. IND for our global placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation as well as the ongoing enrollment of a placebo-controlled investigator-initiated study in the U.S.”
Kiniksa’s Phase 2/3 clinical trial protocol is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mavrilimumab relative to placebo in addition to standard of care therapy in the treatment of patients with severe COVID-19 pneumonia and hyperinflammation.
On Saturday, June 6, 2020, at EULAR 2020, Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy, delivered 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab in non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation. The presentation, entitled Mavrilimumab Improves Outcomes in Severe COVID-19 Pneumonia and Systemic Hyper-Inflammation, is available through the Science section of Kiniksa’s website (www.kiniksa.com).
In the treatment protocol, 13 non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation were treated with a single intravenous dose of mavrilimumab 6 mg/kg upon admission to the hospital. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar baseline characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control-group. All patients received similar standard of care therapy, including antivirals and antibiotics.
Over the course of the 28-day follow-up period, mavrilimumab-treated patients experienced earlier and improved clinical outcomes than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations, and no deaths.
Death occurred in 0% (n=0/13) of mavrilimumab-treated patients by Day 28, compared to 27% (n=7/26) of control-group patients (p=0.086).
8% (n=1/13) of mavrilimumab-treated patients progressed to mechanical ventilation by Day 28, compared to 35% (n=9/26) of control-group patients who progressed to mechanical ventilation or died (p=0.077).
100% (n=13/13) of mavrilimumab-treated patients and 65% (n=17/26) of control-group patients attained the clinical improvement endpoint (defined as improvement of ≥ 2 categories on a 7-point scale for assessment of clinical status) by Day 28 (p=0.0001).
Fever resolved in 91% (n=10/11 febrile patients) of mavrilimumab-treated patients by Day 14, compared to 61% (n=11/18 febrile patients) of control-group patients (p=0.0093).
Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status.
P-values above are unadjusted for multiplicity. Mavrilimumab was well-tolerated in all patients, without infusion reactions.
“The 28-day clinical outcomes data from the treatment protocol with mavrilimumab in COVID-19 pneumonia and hyperinflammation are consistent with the recently-reported 14-day dataset,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “Mavrilimumab-treated patients showed earlier and improved clinical outcomes compared to matched contemporaneous control-group patients throughout the protocol. These data are encouraging, and we look forward to evaluating mavrilimumab further in this patient population through placebo-controlled studies. To this end, we are pleased to announce the active U.S. IND for our global placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation as well as the ongoing enrollment of a placebo-controlled investigator-initiated study in the U.S.”
Kiniksa’s Phase 2/3 clinical trial protocol is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mavrilimumab relative to placebo in addition to standard of care therapy in the treatment of patients with severe COVID-19 pneumonia and hyperinflammation.
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