AB Science is providing a summary of the web conference held on June 5, 2019
Paris, June 5 2019, 9pm AB Science outlook for 2019 - Summary of webcast part 2 AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), is providing a summary of the web conference held on June 5, 2019 on its clinical programs outside of amyotrophic lateral sclerosis and mastocytosis. Severe asthma
The development of masitinib in asthma is based on the targeting of mast cells [1 ;2 ;3;4].
The clinical development program in asthma is comprised of one proof of concept study [5], one pivotal study is severe asthma uncontrolled by oral corticosteroids (OCS), and one pivotal study in severe asthma uncontrolled by inhaled corticosteroids (ICS). The first phase 2/3 (study AB07015) is evaluating masitinib at the dose of 6.0 mg/kg/day in patients treated with severe asthma uncontrolled with high dose of OCS. IDMC reviewed safety data every six months and always recommended the continuation of the study based on review of safety data. Based on interim analysis, IDMC recommended the continuation of study AB07015 with no requirement to increase the study sample size. This recommendation from the IDMC means that the probability of success of the study is above 80%, assuming that the patients enrolled after the interim analysis behave similarly to those analyzed at the interim analysis. The next step for this study is the final read-out, which is expected in Q3 2019. The second phase 3 (study AB14001) is evaluating masitinib 6.0 mg/kg/day in patients treated with severe asthma uncontrolled with high dose of ICS and with high level of eosinophils. The next step for this study is the final read-out, which is expected in Q4 2019.
Masitinib positioning differs from registered treatments (tyrosine kinase inhibitor, targeting of mast cells, orally administered drug, potential claim in severe asthma uncontrolled by OCS regardless of eosinophil levels). Progressive forms of Multiple Sclerosis
Data show that mast cells can actively participate in the pathogenesis of multiple sclerosis, as the presence of mast cells (MCs) and increased concentration of MCs constituent have been reported in MS plaques [6].
The clinical development program in progressive forms of MS is comprised of one proof of concept study [7], and one pivotal study. The phase 2/3 (study AB07002) is evaluating two doses of masitinib (4.5 mg/kg/day and 6.0 mg/kg/day) in patient with primary and secondary progressive MS. IDMC reviewed safety data every six months and always recommended the continuation of the study based on review of safety data. Based on interim analysis, IDMC recommended the continuation of study AB07002 with no requirement to increase the study sample size. This recommendation from the IDMC means that the probability of success of the study is above 80%, assuming that the patients enrolled after the interim analysis behave similarly to those analyzed at the interim analysis. The next step for this study is the final read-out, which is expected in Q3 2019.
Masitinib differentiates from registered drugs, as these drugs are not administrated orally (intravenous form). There is still a need in MS for new drugs, in particular based on different mechanism of action. Alzheimer’s disease
The rationale for evaluating masitinib in Alzheimer’s Disease is based on masitinib’s targeting of mast cells and microglia via inhibition of the c-Kit, Lyn, and CSF1R kinases, and inhibition of Fyn.
The clinical development program in Alzheimer’s Disease is comprised of one proof of concept study [8], and one pivotal study. The phase 2/3 (study AB09004) is evaluating two doses of masitinib (4.5 mg/kg/day and 6.0 mg/kg/day) in patient with mild or moderate forms of Alzheimer’s Disease. IDMC reviewed safety data every six months and always recommended the continuation of the study based on review of safety data. The next step for this study is an interim analysis planned in June 2019, based on 75% of patient enrolled and reaching the 6 months endpoint. Final read-out of the study is planned in Q4 2019.
There is no approved drug given as an add-on to cholinesterase inhibitors or memantine in mild to moderate forms of Alzheimer’s disease. These drugs do not compete with masitinib, which is given as an add-on to these treatments. Metastatic Castrate Resistant Prostate Cancer (mCRPC)
The clinical development program in mCRPC is comprised of one proof of concept study, and one pivotal study. The phase 3 (study AB12003) is evaluating masitinib at 6.0 mg/kg/day in combination with docetaxel in first line treatment of mCRPC. The primary analysis is planned in the overall study population and in a pre-specified subgroup based on biomarker (undisclosed to protect intellectual property). This targeted subgroup is estimated to account for about two-thirds of the eligible population. IDMC reviewed safety data every six months and always recommended the continuation of the study based on review of safety data. Based on the interim analysis, the IDMC recommended the continuation of the study in the pre-specified sub-population with a small resampling. This recommendation from the IDMC means that the probability of success of the study is 80% in the selected sub-population, assuming that the patients enrolled after the interim analysis behave similarly to those analyzed at the interim analysis. The next step for this study is the final read-out, which is expected in 2020.
The only approved drug in metastatic castration resistant Prostate cancer eligible to chemotherapy is Docetaxel. Masitinib does not compete with Docetaxel as it is given in combination with this drug. Pancreatic cancer
The clinical development program in metastatic or locally advanced pancreatic cancer is comprised of one proof of concept study [9], one phase 2/3 pivotal study [10] and one confirmatory pivotal study. The phase 2/3 study (AB07012) enabled the identification of a subgroup based on the level of pain (marker of mast cell activation) at baseline where survival was statistically increased. The confirmatory phase 3 (study AB12005) is evaluating masitinib 6.0 mg/kg/day in combination with gemcitabine in first line treatment of locally advanced or metastatic pancreatic cancer. IDMC reviewed safety data every six months and always recommended the continuation of the study based on review of safety data. The next step for this study is an interim analysis planned in June 2019. Final read-out of the study is planned in 2020.
Masitinib differentiates from registered drugs (orally administered drug, less restrictive eligibility criteria). Masitinib intellectual Property Status Masitinib IP rights are secured up to 2031 in progressive forms of MS, until 2032 in severe asthma, and 2033 in pancreatic cancer.
AB8939
AB8939 is a microtubule destabilizer, that is 100 times more potent than doxorubicine (the reference drug in acute myeloid leukemia). AB8939 differs from other drugs targeting microtubule as it is a synthetic drug not derived from nature and as it is not transported by PgP protein, thereby overcoming multidrug resistance. AB8939 is first developed in acute myeloid leukemia since cancer cells proliferate rapidly in this disease. AB8939 has the potential to be developed in other cancers in a second step.
AB Science is planning to launch a phase 1/2 study with AB8939 to investigate its tolerability and efficacy in patients with Acute Myeloid Leukemia. References About masitinib About AB Science Further information is available on AB Science’s website: www.ab-science.com. Forward-looking Statements - AB Science 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 AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 "Risk Factors" of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB Science Attachment |
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