Altair Therapeutics Reports Successful Completion of Phase I Study of Inhaled AIR645
Data Shows Safety and Tolerability of First-in-Class Dual IL-4/IL-13 Inhibitor with Pharmacokinetics Supporting Once-Weekly Asthma Treatment
No serious or severe adverse events or dose-limiting toxicities were observed in healthy subjects exposed to single or repeated doses of AIR645. There were no changes in laboratory safety assessments, vital signs, electrocardiograms or spirometry attributed to study drug. Inhalation administration of AIR645 resulted in prolonged local exposure in the airways with a half-life in induced sputum of approximately five days and was independent of dose. Plasma AIR645 exposure was reproducibly detected only at the top doses administered (30 mg single dose arm; 20 mg multiple dose arm), suggesting very low systemic drug absorption.
“Demonstration of sustained pulmonary exposure and an excellent safety profile is an important milestone in the development of AIR645. Other drugs in this class have recently demonstrated significant efficacy following systemic administration in patients with dyslipidemia, prostate cancer and multiple sclerosis,” said Michael Hodges, MD., Chief Medical Officer of Altair Therapeutics.
According to William Busse, MD, Professor and Chair, Department of Medicine, University of Wisconsin, “The cytokines IL-4 and IL-13 are key factors that may contribute to clinical aspects of asthma, including inflammation, the development of allergies, and airway hyper-responsiveness. These features make efforts to block the actions of these two cytokines an attractive target for long-term treatment of asthma. The newly released information that an inhaled antisense drug, that blocks the effects of IL-4 and IL-13, can be safely and effectively delivered to the lung is exciting and represents a significant advance in developing new treatments for asthma. Furthermore, the possibility that this product can be given once per week is also unique and affords an advantage of improving adherence and thus effectiveness.”
“The AIR645 phase I safety and pharmacokinetic data and supporting preclinical pharmacology suggest that this drug may be a valuable therapeutic for asthma,” said Joel Martin, Ph.D., President and CEO of Altair Therapeutics. “AIR645 utilizes the same chemical modifications and design as Mipomersen, licensed to Genzyme by Isis Pharmaceuticals and now in phase III trials for familial hypercholesterolemia.”
AIR645 is a dual inhibitor of IL-4 and IL-13, pro-inflammatory cytokines which are implicated in the pathogenesis of asthma, allergic rhinitis and other inflammatory disorders. AIR645 is a 2'-O-methoxyethyl second-generation antisense drug targeting the mRNA that encodes the alpha subunit of the human IL-4 receptor (IL-4RÎ±). IL-4RÎ± is the signaling chain that is shared by the IL-4 and IL-13 receptors and is required for cellular responses to IL-4 and IL-13. AIR645 has the potential for less frequent administration with improved local and systemic safety. AIR645 was discovered by Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) and licensed to Altair Therapeutics.
About Altair Therapeutics
Based in San Diego, Altair Therapeutics, Inc. is a privately-held biopharmaceutical company developing novel therapeutics to treat human respiratory diseases. Altair Therapeutics' lead product is AIR645, the first in a new class of inhaled drugs that incorporate proprietary, second-generation antisense chemistry.
Posted: May 2009