A specific active immunotherapy (SAIT) to control cholesterol levels in blood
Cardiovascular disease still accounts for the greatest number of deaths worldwide. PCSK9-inhibition reduces the risk of cardiovascular events by regulation of the LDL (low density lipoprotein) receptor, one of the transporters of cholesterol in blood.
(firmenpresse) - Vienna (Austria), 27. August 2018: Cardiovascular disease still accounts for the greatest number of deaths worldwide. PCSK9-inhibition reduces the risk of cardiovascular events by regulation of the LDL (low density lipoprotein) receptor, one of the transporters of cholesterol in blood. The protein PCSK9 binds to the LDL-cholesterol receptor and enhances its degradation, which leads to the reduced clearance of LDLc and a higher risk of atherosclerosis.
So far, blocking PCSK9 was clinically limited by the need for frequent injections with therapeutic antibodies and economically restricted by their high cost. As a promising novel strategy, active immunotherapy that induces a long-lasting PCSK9-specific antibody response may overcome these disadvantages to reduce the burden of cardiovascular disease as the major cause of death in the developed world. On the basis of this innovative concept AFFiRiS Inc. (Vienna, Austria) developed two products, AT04A and AT06A, which were tested at the Medical University of Vienna (Dept. of Clinical Pharmacology). Results of the first in-human study of this immunotherapy targeting PCSK9 actively are now available.
72 healthy individuals with slightly elevated LDL-cholesterol (75 to 200 mg/dl) were enrolled in three parallel treatment groups. Participants were randomized to receive AT04A, AT06A or placebo. Immunizations were administered as three priming immunizations at four-weekly intervals. In a second part of the study, 50 participants received a booster immunization at week 60 with a follow-up until week 90, including an interim analysis at week 70. The primary study objective was safety and tolerability of AT04A and AT06A with immunogenicity and efficacy as secondary, exploratory study objectives.
Both immunotherapies, AT04A and AT06A, were safe and well tolerated. No significant difference in the safety profile was observed between active and placebo treatment groups with the exception of injection site reactions. These local reactions who received AT04A or AT06A developed a PCSK9-specific antibody response, which was readily reactivated after booster immunization at week 60. The mean LDL-cholesterol reduction after the booster was 13.3% at week 70 when comparing AT04A with placebo. Over the entire study period of 90 weeks, the difference in LDL-cholesterol reduction between AT04A and placebo was statistically highly significant (p
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 28.08.2018 - 06:35 Uhr
Sprache: Deutsch
News-ID 1540244
Anzahl Zeichen: 3012
contact information:
Contact person: Till C. Jelitto
Town:
Vienna
Phone: +43 / (0)1 / 505 70 44
Kategorie:
Research & Development
Typ of Press Release: Erfolgsprojekt
type of sending: Veröffentlichung
Date of sending: 28.08.2019
Anmerkungen:
Diese Pressemitteilung wurde bisher 395 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"A specific active immunotherapy (SAIT) to control cholesterol levels in blood
"
steht unter der journalistisch-redaktionellen Verantwortung von
PR&D – Public Relations for Research & Education (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
