Kamada Ltd. (NASDAQ:KMDA) (TASE: KMDA), a plasma-derived protein
therapeutics company focused on orphan indications, reports the
discussion of the updated data from the Company’s European and Canadian
Phase 2/3 clinical study of inhaled alpha-1 antitrypsin (AAT) to treat
alpha-1 antitrypsin deficiency (AATD) during a panel discussion
entitled, “New Treatment Prospects for AATD Patients: Results from a
Phase 2/3 Inhaled AAT Trial,” which was chaired by Robert A. Sandhaus,
Ph.D., M.D., FCCP, Founder and Director of the Alpha1- Antitrypsin
Deficiency Program at National Jewish Health Hospital in Denver,
Colorado, and the Clinical Director of the Alpha-1 Foundation. The panel
included Key Opinion Leaders (KOLs) who specialize in treating patients
with AATD, and was held during the American Thoracic Society (ATS) 2015
International Conference held from May 15-20, 2015 in Denver, Colorado.
The slides from the presentation are now available and a video of the
panel discussion in its entirety will be available on the homepage of
the Company’s website at www.kamada.com
beginning May 25, 2015.
In addition to previously announced results that focused on the
statistically significant lung function beneficial effect, additional
data on the nature of symptoms of the first exacerbation, a clinically
important measurement, were reported during the panel session. In the
study, three major exacerbation symptoms comprised the severity nature
of an exacerbation: dyspnea, sputum volume and sputum color. These
symptoms were scored by patients using a daily electronic diary device.
The inhaled AAT treated group showed a statistically significant lower
symptoms score (for both dyspnea and volume) for patients
who experienced first exacerbation versus the placebo group for events:
-
0-10 days for dyspnea the AAT group scored 11.94 vs 12.25 for placebo,
p=0.0243
-
0-14 days for dyspnea the AAT group scored 11.58 vs 11.78 for placebo,
p=0.0817
-
0-10 for sputum volume the AAT group scored 1.27 vs 1.38
for placebo, p=0.0334,
-
0-14 days for sputum volume the AAT group scored 1.23 vs 1.32 for
placebo, p=0.0595
In addition, the inhaled AAT group had a lower percentage of patients
who experienced all 3 symptoms during the first exacerbation (type I
exacerbation) of the first exacerbation versus the placebo group (18.8%
vs. 31.3%, p=0.06).
Key highlights of the updated data set include:
-
Statistically significant lung function efficacy
-
Change in the nature of exacerbations (reduction in number of Type 1-
exacerbations (trend) and reduction in dyspnea score (statistically
significant)
-
The trial did not achieve statistical significance in primary endpoint
of time to first exacerbation
-
The drug is safe and tolerable
Key comments by the KOLs who participated in the panel discussion:
“The lung function results seen in this study are striking and the
change is quite rapid. This is the first time a controlled randomized
study in AATD has demonstrated actual efficacy in lung function, the
gold standard endpoint in respiratory trials,” said Kenneth R. Chapman,
M.D., Director, Canadian Registry Alpha-1 Antitrypsin Deficiency, Asthma
and Airway Centre, Toronto Western Hospital, University of Toronto,
Toronto, Canada.
“These results reinforce the known anti-inflammatory effects of AAT on
neutrophil migration and elastase release, and thereby, on inflammation
in the lung. This is a very important finding as it could be applicable
in a number of respiratory conditions where lung inflammation exists,”
explained Gerry McElvaney, M.D., Professor of Medicine at Royal College
of Surgeons in Ireland (RCSI), Dublin Ireland.
“The change in lung function would support the use of this treatment in
our AATD patient population and I would be most interested in seeing the
long-term benefits of this therapy in these patients,” stated Jan Stolk,
M.D., Department of Pulmonology, Leiden University Medical Center,
Leiden, The Netherlands.
“The study has shown that inhaled AAT has the capacity of changing the
nature of exacerbation events. The results indicated that the treatment
lead to exacerbations with fewer symptoms. This change was associated
with a benefit in lung function which may explain the effect,” noted
Robert A. Stockley, M.D., Lung Investigation Unit, Queen Elizabeth
Hospital, Birmingham University, Birmingham, United Kingdom.
“We are especially pleased to report updated results from our European
Phase 2/3 clinical study, which showed clinically and statistically
significant improvements in spirometric measures of lung function and
complementary efficacy in the severity of the first exacerbation. These
data are particularly exciting as they demonstrate clinical primacy in
efficacy for inhaled AAT specifically and in AATD in general,” stated
David Tsur, co-founder and Chief Executive Officer of Kamada.
“We continue with our plans to submit a Marketing Authorization
Application with the European Medicines Agency for approval of our
inhaled AAT by year-end 2015 and are confident that the totality of this
data set will support our efforts to bring inhaled AAT to the market
place in order to provide an adequate, efficacious, safe and easy-to-use
answer to the current unmet medical need of these orphan patients.
“We remain committed to the AATD patient community and appreciate the
ongoing support for and recognition of these positive data from the
leading clinicians in the field and from patient advocacy groups
worldwide,” concluded Mr. Tsur.
About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan
indications, and has a commercial product portfolio and a robust
late-stage product pipeline. The Company uses its proprietary platform
technology and know-how for the extraction and purification of proteins
from human plasma to produce Alpha-1 Antitrypsin (AAT) in a
highly-purified, liquid form, as well as other plasma-derived proteins.
AAT is a protein derived from human plasma with known and
newly-discovered therapeutic roles given its immunomodulatory,
anti-inflammatory, tissue-protective and antimicrobial properties. The
Company’s flagship product is Glassia®, the first and only liquid,
ready-to-use, intravenous plasma-derived AAT product approved by the
U.S. Food and Drug Administration. Kamada markets Glassia in the U.S.
through a strategic partnership with Baxter International. In addition
to Glassia, Kamada has a product line of nine other injectable
pharmaceutical products that are marketed through distributors in more
than 15 countries, including Israel, Russia, Brazil, India and other
countries in Latin America, Eastern Europe and Asia. Kamada has five
late-stage plasma-derived protein products in development, including an
inhaled formulation of AAT for the treatment of AAT deficiency that
completed pivotal Phase 2/3 clinical trials in Europe and entered Phase
2 clinical trials in the U.S. Kamada also leverages its expertise and
presence in the plasma-derived protein therapeutics market by
distributing 10 complementary products in Israel that are manufactured
by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of
Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E
of the U.S. Securities Exchange Act of 1934, as amended, and the safe
harbor provisions of the U.S. Private Securities Litigation Reform Act
of 1995. Forward-looking statements are statements that are not
historical facts, such as statements regarding assumptions and results
related to financial results forecast, commercial results, timing and
results of clinical trials and EMA and U.S. FDA authorizations.
Forward-looking statements are based on Kamada’s current knowledge and
its present beliefs and expectations regarding possible future events
and are subject to risks, uncertainties and assumptions. Actual results
and the timing of events could differ materially from those anticipated
in these forward-looking statements as a result of several factors
including, but not limited to, unexpected results of clinical trials,
delays or denial in the U.S. FDA or the EMA approval process, additional
competition in the AATD market or further regulatory delays. The
forward-looking statements made herein speak only as of the date of this
announcement and Kamada undertakes no obligation to update publicly such
forward-looking statements to reflect subsequent events or
circumstances, except as otherwise required by law.
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