PRESS RELEASE
STUDY DESIGN FOCUSES DIRECTLY ON MASITINIB’S ANTIVIRAL ACTIVITY AGAINST THE COVID-19 VIRUS (SARS-CoV-2) FOR THE TREATMENT OF PATIENTS AT AN EARLY STAGE OF THE DISEASE
WITH TWO PHASE 2 STUDIES, MASITINIB IS A LEADING CANDIDATE IN THE DEVELOPMENT OF ORAL PROTEASE INHIBITORS FOR TREATMENT OF NON-HOSPITALIZED AND HOSPITALIZED COVID-19 PATIENTS
Masitinib is being developed as a novel SARS-CoV-2 protease inhibitor antiviral therapy, with two phase 2 studies in the complementary populations of non-hospitalized (non-severe) and hospitalized (severe) COVID-19 patients. Masitinib is considered particularly well-suited for the treatment of COVID-19 soon after infection (prior to hospitalization), when an antiviral is likely to have most effect and because of its convenient oral (tablet) administration. Currently, masitinib is one of the most advanced oral protease inhibitor antiviral drugs in clinical development, as its safety is well-known, having already been evaluated on thousands of patients in other indications.
Study AB21002 will evaluate the antiviral efficacy of masitinib at 3 different dosages, administered as an add-on to best supportive care, with respect to placebo plus best supportive care. The study will enroll 78 patients (age ≥18 without an upper age limit) at medical centers in
This clinical trial follows the discovery published in the journal Science [1] that masitinib is a direct antiviral drug blocking the replication of SARS-CoV-2 (the virus that causes COVID-19), by inhibiting the critical non-structural protein 5 (Nsp5) target (the main protease also named 3CLpro) necessary for the viral replication cycle. In a mice model infected with SARS-CoV-2, masitinib was shown to dramatically reduce the viral load, the pro-inflammatory cytokines levels, and to improve mice survival at clinically relevant dosages. Masitinib therefore has a dual action against COVID-19; a direct antiviral mechanism of action and also an anti-inflammatory action that that is of relevance for treating COVID-19 related acute respiratory distress syndrome and cytokine storm.
Professor
Despite the availability of effective vaccines, the need for antiviral therapeutics will remain high because a substantial part of the world population will not be vaccinated. In addition, SARS-CoV-2 is rapidly evolving, leading to the selection and accumulation of mutations, mainly in the Spike protein, that affect the transmissibility of the virus, its ability to evade immunity and its suspected pathogenicity. Variants of concern are more contagious and susceptible of immune escape, thereby challenging monoclonal antibodies (mAbs) therapies, threatening the protective efficacy of current vaccines and leading to waves of coronaviruses.
At this time, there is a lack of antiviral compounds available to treat COVID-19. Consequently, there is an urgent need to develop new antiviral compounds in order to counter emerging variants of concerns.
The development of effective antiviral therapies is based on two complementary strategies:
- Drugs targeting the polymerase: Several drugs targeting polymerase are currently in clinical development, with remdesivir (Gilead) being approved.
- Drugs targeting the protease: Drugs targeting viral 3C-like protease (as is the case for masitinib) are an attractive therapeutic option for COVID-19, in part because they are considered less vulnerable to the development of SARS-CoV-2 drug resistance; however, no such drugs targeting 3C-like protease are yet registered for use in the treatment of COVID-19.
As is the case to treat HIV (human immunodeficiency virus), it is expected that an effective treatment strategy against SARS-CoV-2 would depend on the combination of drugs targeting both the polymerase and the protease of the virus.
Reference
[1] Drayman N, DeMarco JK, Jones KA, et al. Masitinib is a broad coronavirus 3CL inhibitor that effectively blocks replication of SARS-CoV-2. Science. 2021;373(6553). doi: 10.1126/science.abg5827
[2] Press release dated
About masitinib
Masitinib is a orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
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 AB21002 ANTI-VIRAL vENG VF
Source:
2021 GlobeNewswire, Inc., source