Masitinib

AB Science: New research shows that masitinib limits neuronal damage in a model of neuroimmune-driven neurodegenerative disease

Retrieved on: 
Wednesday, March 13, 2024
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Findings have been published on the bioRxiv preprint service as an article entitled, ‘Masitinib limits neuronal damage, as measured by serum neurofilament light chain concentration, in a model of neuroimmune-driven neurodegenerative disease’.

Key Points: 
  • Findings have been published on the bioRxiv preprint service as an article entitled, ‘Masitinib limits neuronal damage, as measured by serum neurofilament light chain concentration, in a model of neuroimmune-driven neurodegenerative disease’.
  • The neuroprotective action of masitinib was studied in an animal model of experimental autoimmune encephalitis (EAE).
  • Results showed that masitinib can significantly lower serum NfL levels, and by extension therefore, neuronal damage, in a neuroimmune-driven neurodegenerative disease model, with concomitant reduction in pro-inflammatory cytokines and slowing of clinical symptoms.
  • Masitinib limits neuronal damage, as measured by serum neurofilament light chain concentration, in a model of neuroimmune-driven neurodegenerative disease.

AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

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Thursday, March 7, 2024
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SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
    AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
  • Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.
  • AB Science will be free to continue the development of masitinib in SCD based on phase 2 data with biomarkers.

AB Science receives notice of allowance for European patent covering masitinib until 2036 in the treatment of mastocytosis

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Monday, January 15, 2024
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AB Science SA (Euronext - FR0010557264 - AB) today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e.
  • This new European patent provides intellectual property protection for masitinib in this indication until October 2036.
  • Masitinib is positioned as a treatment of severely symptomatic systemic mastocytosis patients, including the subvariants of indolent and smoldering systemic mastocytosis, who are unresponsive to optimal symptomatic treatment.
  • The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patent application, EP3359195A1, after the completion of certain formal procedural steps.

AB Science receives Notice of Allowance for European patent covering masitinib in the treatment of metastatic castrate refractory prostate cancer (mCRPC)

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Monday, June 26, 2023
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This new European patent provides intellectual property protection for masitinib in the treatment of mCRPC until 2042.

Key Points: 
  • This new European patent provides intellectual property protection for masitinib in the treatment of mCRPC until 2042.
  • Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy; that is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.
  • The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patent application, EP4175639A1, after the completion of certain formal procedural steps.
  • A European NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability under the European Patent Convention.

AB Science announces issuance of a Canadian patent for masitinib in the treatment of ALS with protection until 2037

Retrieved on: 
Thursday, June 1, 2023
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A NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability.

Key Points: 
  • A NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability.
  • In addition to patent protection, masitinib is also eligible for regulatory data protection in Canada, preventing generic competition for a period of 8 years following initial approval.
  • As a reminder, Health Canada had granted authorization to file a new drug submission for masitinib in the treatment of ALS under the notice of compliance with conditions (NOC/c) policy.
  • On May 9, 2023, AB Science announced that Health Canada had resumed its review of the application of masitinib in the treatment of ALS.

AB Science announces masitinib patent granted in Japan for the treatment of amyotrophic lateral sclerosis, strengthening the Company’s intellectual property position until 2037

Retrieved on: 
Tuesday, April 18, 2023
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AB SCIENCE ANNOUNCES MASITINIB PATENT GRANTED IN JAPAN FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS, STRENGTHENING THE COMPANY’S INTELLECTUAL PROPERTY POSITION UNTIL 2037

Key Points: 
  • AB SCIENCE ANNOUNCES MASITINIB PATENT GRANTED IN JAPAN FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS, STRENGTHENING THE COMPANY’S INTELLECTUAL PROPERTY POSITION UNTIL 2037
    TO DATE, THIS PATENT HAS BEEN GRANTED IN 12 REGIONS INCLUDING EUROPE, USA, CHINA, ISRAEL AND MOST RECENTLY JAPAN
    AB Science SA (Euronext - FR0010557264 - AB) today announced that the patent office of Japan has issued a Notice of Allowance (NOA) for a patent relating to methods of treating amyotrophic lateral sclerosis (ALS) with its lead compound masitinib (JP 2022037132A).
  • As a result, intellectual property protection for masitinib is secured in ALS until 2037.
  • An NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability.
  • This new patent provides strong protection for masitinib in the treatment of ALS until 2037 in the key geographic areas where masitinib could be marketed.”

AB Science announces that it has submitted its response to the day 120 questions in the EMA regulatory review of masitinib in amyotrophic lateral sclerosis and clarifies the new timeline for responding to Health Canada

Retrieved on: 
Tuesday, April 4, 2023
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As part of the ongoing EMA procedure, AB Science has submitted its responses to the Day 120 assessment of the procedure.

Key Points: 
  • As part of the ongoing EMA procedure, AB Science has submitted its responses to the Day 120 assessment of the procedure.
  • Because EMA and Health Canada regulatory procedures were concurrent and in order to ensure the best quality of responses in both procedures, AB Science, in agreement with Health Canada, has extended the response period to Health Canada by 30 days.
  • The new deadline to respond to Health Canada is April 12, 2023.
  • AB Science has received support from several ALS patient groups in Canada and Europe for the conditional registration of masitinib in ALS.

AB Science has received approval from the U.S. Food and Drug Administration (FDA) to initiate the confirmatory Phase 3 study with masitinib in the treatment of progressive multiple sclerosis

Retrieved on: 
Thursday, December 29, 2022
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AB SCIENCE HAS RECEIVED APPROVAL FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO INITIATE THE CONFIRMATORY PHASE 3 STUDY WITH MASITINIB IN THE TREATMENT OF PROGRESSIVE MULTIPLE SCLEROSIS

Key Points: 
  • AB SCIENCE HAS RECEIVED APPROVAL FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO INITIATE THE CONFIRMATORY PHASE 3 STUDY WITH MASITINIB IN THE TREATMENT OF PROGRESSIVE MULTIPLE SCLEROSIS
    This decision follows authorizations received from several European countries, including the French Agency (ANSM).
  • This is a randomized, double-blind, Phase 3 study to evaluate the safety and efficacy of masitinib 4.5 mg/kg/day in patients with primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (nSPMS).
  • The primary endpoint of the study is the effect of masitinib on time to confirmed disability progression.
  • Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial.

AB Science today announced publication of results from its positive study of masitinib in severe asthma uncontrolled by oral corticosteroids in the peer-reviewed Journal of Asthma and Allergy

Retrieved on: 
Tuesday, June 7, 2022
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Results from this phase 3 study showed that corticosteroid-dependent severe asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared with those in a placebo-control group that did not receive masitinib.

Key Points: 
  • Results from this phase 3 study showed that corticosteroid-dependent severe asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared with those in a placebo-control group that did not receive masitinib.
  • Phase 3 study (AB07105) evaluating oral masitinib at 6 mg/kg/d versus placebo in severe asthma uncontrolled by oral corticosteroids (OCS) met its primary endpoint.
  • Masitinib significantly decreased the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by OCS.
  • 13 months)
    Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, targeted population, and broader eosinophil level.

AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the Swedish Medical Products Agency

Retrieved on: 
Wednesday, February 2, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
  • To date, masitinib has demonstrated positive Phase 2B/3 results in three neurodegenerative disorders, namely, Alzheimers disease [1], amyotrophic lateral sclerosis (ALS) [2,3], and progressive forms of multiple sclerosis [4].
  • This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis.
  • Published 2021 Jul 19. doi:10.1177/17562864211030365
    [4] Vermersch P, Hermine O. Masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis: results from phase 3 study AB07002.