AB Science announces that it has received the first

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PRESS RELEASE

AB SCIENCE ANNOUNCES THIS HE RECEIVED THE FIRST AUTHORIZATION TO RESUME PATIENT REGISTRATION IN THE PHASE 3 STUDY OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS (ALS)

Paris, August 23, 2021, 7:30 p.m. CET

AB Science SA (Euronext – FR0010557264 – AB) announced today that it has received the first authorization to resume patient recruitment in the phase 3 confirmatory study of masitinib (AB19001) in the treatment of amyotrophic lateral sclerosis (ALS).

This authorization from a competent national authority follows the submission of a modified protocol for study AB19001 which includes a new risk management plan to strengthen cardiac safety.

This first authorization comes from a European national agency, namely Norway.

As a reminder, AB Science took the decision on June 1st 2021 to temporarily suspend the recruitment of new patients in study AB19001.

AB Science hopes to be able to gradually resume worldwide registrations during the month of September.

Therefore, the voluntary decision to suspend the recruitment of new patients will have resulted in a 3-month hiatus in the study recruitment schedule.

About studies AB19001 and AB10015

As a reminder, study AB19001 is an international, multicenter, randomized, double-blind, placebo-controlled, 3 parallel group, Phase 3 study aimed at comparing the efficacy and safety of masitinib in combination with riluzole versus placebo. in combination with riluzole for the management of patients with ALS.

The study is intended to confirm the previously published results of the first phase 2b / 3 study (AB10015), which demonstrated that masitinib 4.5 mg / kg / day in combination with riluzole significantly slowed the d scale. Functional assessment of revised amyotrophic lateral sclerosis (ALSFRS-R) decreased by 27% compared to riluzole alone at week 48 (p-value

Study enrollment targets people with ALS who have mild to moderate impairment in functionality at baseline. This is closely related to the patient population that showed the greatest survival benefit with masitinib in the long-term survival analysis. The primary endpoint of study AB19001 is the absolute change from baseline in functional score assessed by ALSFRS-R after 48 weeks of treatment.

About amyotrophic lateral sclerosis
Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disease characterized by progressive loss of upper and lower motor neurons at the spinal or bulbar level. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the progressive degeneration and death of motor neurons. In ALS, the upper motor neurons and lower motor neurons degenerate or die and stop sending messages to the muscles.
The prevalence of ALS in Western countries is fairly uniform at 6 per 100,000 people, corresponding to about 30,000 cases in Europe and 20,000 in the United States.
The first drug treatment for ALS, riluzole (Rilutek), was approved in 1995. In Europe, no new treatment has been approved since riluzole.

About masitinib
Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, cells important for immunity, by inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a variety of conditions in oncology, inflammatory diseases, and certain diseases of the central nervous system. In oncology, because of its immunotherapeutic effect, masitinib may have an effect on survival, alone or in combination with chemotherapy. By its activity on mast cells and microglia and therefore inhibiting the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain inflammatory and central nervous system diseases and the degeneration of these diseases.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKI), a class of targeted proteins whose action is essential in signaling pathways within cells. . Our programs only target diseases with high unmet medical needs, often fatal with short-term survival or rare or refractory to the previous line of treatment.
AB Science has developed an exclusive portfolio of molecules and the Company’s flagship compound, masitinib, has already been registered in veterinary medicine and is being developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and is listed on Euronext Paris (ticker: AB).

Further information is available on the AB Science website:
www.ab-science.com.

Forward-looking statements – AB Science
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 plans, objectives, intentions and expectations regarding financial results, events, operations, future services, development. of products and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” and other similar terms. Although AB Science believes that these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties which are difficult to predict and generally beyond the control of AB Science and which may involve the results. and actual events differ materially from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the development of the Company’s products which may not be successful or to the marketing authorizations granted by the competent authorities or, more generally, any factor that may affect the marketing capacity of the products developed by the Company. AB Science, as well as those developed or identified in public documents published by AB Science. AB Science declines any obligation or commitment to update forward-looking information and statements, subject to applicable regulations, in particular articles 223-1 and following. of the AMF general regulations.

For more information, please contact:

AB Sciences
Financial Communication & Press Relations
investors@ab-science.com

Media Relations – United States

RooneyPartners
Kate barrette
kbarrette@rooneyco.com

+1 646 432 0191

Press relations – France

NewCap
Arthur Rusty
arouille@newcap.fr

+33 (0) 1 44 71 00 15

  • Recruitment resume AB19001 VENG VF

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