Altair Therapeutics Reports Successful Completion of Phase I Study of Inhaled AIR645

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Mon May 18, 2009 9:00am EDT

Data Shows Safety and Tolerability of First-in-Class Dual IL-4/IL-13 Inhibitor
with Pharmacokinetics Supporting Once-Weekly Asthma Treatment
SAN DIEGO--(Business Wire)--
Altair Therapeutics, Inc., a privately-held, biopharmaceutical company
developing novel therapeutics for respiratory diseases, today reported results
from its phase I study evaluating the safety, tolerability and pharmacokinetics
of its lead product, once-weekly inhaled AIR645, in healthy volunteers. AIR645
is a non-steroidal dual inhibitor of cellular responses to interleukin (IL)-4
and IL-13, cytokines that play a critical role in development and progression of
asthma, rhinitis and other allergic disorders. Results presented today at the
2009 International Conference of the American Thoracic Society (ATS) within the
Mini-Symposium "New Treatment Approaches for Asthma and Allergy" showed that
inhaled AIR645 was safe, well tolerated and had dose-dependent exposure in the
airways. These results demonstrate the potential of AIR645 as a convenient
once-weekly treatment for asthma and other respiratory disorders. Later this
year, Altair plans to initiate a phase II efficacy study in patients with
asthma. 

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." 

About AIR645

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-4Rα). IL-4Rα 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. www.altairthera.com





College Hill Life Sciences for Altair Therapeutics
Erik Clausen, 415-230-5385
Erik.Clausen@collegehill.com
Kena Hudson, 415-230-5385
Kena.Hudson@collegehill.com

Copyright Business Wire 2009

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