PRESS RELEASE
POSITIVE RECOMMENDATION OF THE DATA AND SAFETY MONITORING BOARD TO CONTINUE THE PHASE 2 STUDY EVALUATING MASITINIB IN COMBINATION WITH ISOQUERCETIN IN COVID-19
This randomized (1:1), open-label, phase 2 study (AB20001) is designed to evaluate the safety and efficacy of masitinib plus isoquercetin in hospitalised patients with moderate COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19 (level 5). The study is planned to recruit 200 patients (over 18 years of age with no upper age limit).
The primary objective is to improve the clinical status of patients after 15 days of treatment, as measured by the WHO 7-point ordinal scale.
The interim analysis was conducted with one third of the patients evaluated, as planned. The purpose of the interim analysis was to assess the safety and efficacy of the treatment.
The DSMB recommends continuing the study without restrictions in moderate patients (level 4, i.e. hospitalized patients with oxygen supply <6 L/min with SpO2 maintained ≥92%).
In line with this recommendation,
Professor
A second Phase 2 study (study AB21002) evaluating the antiviral activity of masitinib is also ongoing. This study includes non-hospitalized patients with risk factors, as well as hospitalized patients with moderate COVID-19, the latter category being similar to AB20001.
About the study primary endpoint
The 7-point ordinal scale for clinical status is: 1. Not hospitalized, no limitations on activities; 2.Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
About
Founded in 2001,
Further information is available on AB Science’s website:
www.ab-science.com.
Forward-looking Statements -
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While
For additional information, please contact:
Financial Communication & Media Relations
investors@ab-science.com
Media Relations –
RooneyPartners
kbarrette@rooneypartners.com
+1 212 223 0561
Media Relations –
NewCap
Arthur Rouillé
arouille@newcap.fr
+33 (0)1 44 71 00 15
Attachment
- CP Covid VENG VF
Source:
2022 GlobeNewswire, Inc., source