Date: 2017-11-01
Type of
information: update on patient enrollment
phase: 1
Announcement: update
Company: Syntimmune (USA - MA)
Product: SYNT001
Action
mechanism:
- monoclonal antibody. WAIHA is a rare blood disorder in which the immune system produces antibodies that attack a patient’s own red blood cells, the destruction of which can lead to severe, potentially debilitating anemia. There are limited treatment options and other than corticosteroids, no therapies are currently approved to treat WAIHA.
Disease: Warm Autoimmune Hemolytic Anemia (WAIHA)
Therapeutic
area: Autoimmune diseases - Rare diseases
Country: USA
Trial
details:
- This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001. (NCT03075878)
Latest
news:
- • On November 1, 2017, Syntimmune announced that the company is advancing a multicenter, open-label, safety, tolerability, and activity Phase 1b/2a study of SYNT001 in individuals with chronic, stable WAIHA. The study’s primary outcome measures are safety and tolerability. Secondary measures include PK, PD, immunogenicity, and effects on disease activity markers. Interim data for the WAIHA trial are expected in the second half of 2018.
Is
general: Yes
