MILAN, Italy — AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted AAVB-039, the company’s investigational gene therapy for the treatment of Stargardt disease secondary to biallelic mutation in ABCA4, Orphan Drug Designation (ODD). The company...
treatment News
MILAN, Italy — AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AAVB-039, the company’s gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4. The...
LONDON, UK and MILAN, Italy — AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company pioneering therapies for inherited retinal diseases (IRDs), has announced the completion of enrollment in LUCE-1, their Phase 1/2 first-in-human clinical trial evaluating AAVB-081 for the treatment of retinitis pigmentosa associated with Usher syndrome type 1B (USH1B). LUCE-1 is...
MILAN, Italy — AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AAVB-039, the company’s gene therapy program for Stargardt disease. AAVantgarde is now initiating...
Paris, France – AB Science SA (Euronext – FR0010557264 – AB) today announced that the European patent office has issued a Grant Decision for a patent relating to methods of treating severe mastocytosis with its lead compound masitinib (patent EP 3359195A1). This new European patent provides intellectual property (IP) protection...
PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) today announced the publication of a new article on the preprint platform MedRxiv, presenting a post-hoc subgroup analysis of the phase 2b/3 AB10015 study evaluating masitinib in patients with amyotrophic lateral sclerosis (ALS). This article is entitled ‘Efficacy and safety...
PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) announces today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML). AB8939 had already obtained orphan drug designation from the US Food and...
Paris, France – AB Science SA (Euronext – FR0010557264 – AB) announced the identification of a potential biomarker for assessing the activity of masitinib in pathological microglial involvement in Amyotrophic Lateral Sclerosis (ALS). The key characteristics of this newly identified biomarker are as follows: It is a blood-based (plasmatic) biomarker, which...
PARIS, France – AB Science SA (Euronext – FR0010557264 – AB) today announced that the confirmatory Phase 3 study with masitinib in amyotrophic lateral sclerosis (ALS), study AB23005, has been authorized by the first set of European countries (Spain, Greece, Slovenia) in Step 2 of the Clinical Trials Information System (CTIS)...
PARIS, France – AB Science SA 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. a medical use patent) with its lead compound masitinib, based on findings from study AB06006. This new European patent...