SAN DIEGO, March 6, 2017 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today reported that its
wholly-owned subsidiary, Aires Pharmaceuticals, Inc., has entered
into an agreement with the University of
Pittsburgh related to a Phase 1/2 open-label safety and
proof of concept clinical trial of the Company's lead product
candidate, AIR001, for the treatment of Pseudomonas
aeruginosa (P. aeruginosa) infection in cystic
fibrosis (CF) patients. The study is being conducted by the
University of Pittsburgh and the
University of Pittsburgh Medical
Center. Mast's subsidiary will provide study drug and nebulizers
for the study, but no direct financial support.
"We are excited that CF experts at University of Pittsburgh wish to study the
therapeutic potential of AIR001 in this patient population," stated
Brian M. Culley, Chief Executive
Officer of Mast Therapeutics, Inc. "We believe this initiative
opens an entirely new area of potential clinical and commercial
opportunity for AIR001 and enjoys synergy with the pipeline of our
anticipated reverse merger partner, Savara Inc."
"AIR001 may represent a new therapeutic approach for the
treatment of chronic infection in CF patients because it has
demonstrated broad in vitro antimicrobial activity against
P. aeruginosa and other airway pathogens," stated
Edwin L. Parsley, D.O., Chief
Medical Officer of Mast Therapeutics, Inc. "The antimicrobial
activity of nitrite increases under anaerobic and acidotic
conditions such as those found in the CF airways, and in
non-clinical studies, AIR001 has been shown to prevent P.
aeruginosa biotic biofilm growth on the surface of primary CF
airway cells," continued Dr. Parsley.
The objective of the open-label Phase 1/2 study is to determine
the safety of AIR001, a sterile, proprietary sodium nitrite
solution for intermittent inhalation, administered in a dose
escalation manner to adults with CF and P. aeruginosa airway
infection. The study also aims to explore the effects of AIR001 on
measures of lung function, exhaled airway nitric oxide, and
bacterial density. Under the agreement with the University of Pittsburgh, the Company has rights to
use the de-identified data and study results for potential
regulatory submissions.
About Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder that results in
persistent lung infections and permanent and progressive
respiratory disability. CF affects mostly the lungs, but also the
pancreas, liver, kidneys, and intestines. In the lungs of CF
patients, mucus plugs the airways and allows the development of
bacterial biofilms, resulting in chronic infection. Such infection
leads to bronchiectasis, or damaged airways, obstructive lung
disease, and ultimately death from chronic respiratory failure. CF
is a rare, or orphan, disease, affecting approximately 30,000
people in the United States
according to the Cystic Fibrosis Foundation Patient Registry.
About AIR001
AIR001 is a sodium nitrite solution for intermittent inhalation
via nebulization. Nitrite is a direct vasodilator and can be
recycled in vivo to form nitric oxide (NO) independent of
the classical NO synthase (NOS) pathway. Nitrite mediated NO
formation has several beneficial effects, including dilation of
blood vessels and reduction of inflammation and undesirable cell
growth and has demonstrated encouraging results in Phase 2 clinical
trials conducted to date in patients with heart failure with
preserved ejection fraction (HFpEF).
In cystic fibrosis (CF), chronic airway infection results
in cycles of airway inflammation and bronchiectasis that
ultimately lead to early death from respiratory failure.
Pseudomonas aeruginosa (P. aeruginosa) is the most common
infectious pathogen in CF, and once chronic airway infection
is established, P. aeruginosa becomes difficult to eradicate
because of resistance mechanisms including bacterial
growth in biofilms. The high metabolic activity of P.
aeruginosa and with neutrophilic interaction results
in biofilm growth that is largely anaerobic and
which confers resistance to many antibiotics. Bacteria growing
in biotic biofilms can be greater than 100-fold more resistant
to antibiotics. In work by Zemke et. al., nitrite
prevented 99% of biofilm growth. Notably, nitrite resulted in
inhibition of P. aeruginosa growth on primary CF airway
cells at concentrations achievable clinically with AIR001. The
inhibitory effect of nitrite on bacterial oxygen consumption and
biofilm growth did not require nitric oxide (NO) as an
intermediate, as chemically scavenging NO did not block growth
inhibition. These data suggest an NO-radical
independent nitrosative or oxidative inhibition
of respiration as the mechanism of action of nitrite on biotic
biofilms. Thus AIR001 may provide a novel therapy for chronic
P. aeruginosa infection in conditions such as CF and non-CF
bronchiectasis.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical
company headquartered in San Diego,
California. The Company's lead product candidate, AIR001, is
a sodium nitrite solution for intermittent inhalation via
nebulization in Phase 2 clinical development for the treatment of
heart failure with preserved ejection fraction (HFpEF). More
information can be found on the Company's web site at
www.masttherapeutics.com. Mast Therapeutics™ and the
corporate logo are trademarks of Mast Therapeutics, Inc.
The Company has entered into a definitive merger agreement with
Austin, Texas-based Savara Inc.
Under the terms of the agreement, upon the closing of the merger,
the operations of the Company and Savara would be combined and the
stockholders of Savara would be the majority owners of the combined
company. The combined company would focus on the development and
commercialization of novel therapies for the treatment of serious
or life-threatening rare respiratory diseases. Subject to approval
of the Company's and Savara's stockholders and the satisfaction or
waiver of other conditions, the merger is expected to close in Q2
2017.
Safe Harbor Statements
Additional Information about the Proposed Merger and Where to
Find It
In connection with the proposed merger with Savara, the Company
has filed relevant materials with the Securities and Exchange
Commission, or the SEC, including a registration statement on Form
S-4 that contains a prospectus, proxy statement and information
statement. Investors and security holders of the Company are
urged to read these materials when the registration statement
becomes effective because they contain important information about
the Company, Savara and the proposed merger. The proxy
statement/prospectus/information statement and other relevant
materials, and any other documents filed by the Company with the
SEC, may be obtained free of charge at the SEC web site at
www.sec.gov. In addition, investors and security holders may
obtain free copies of the documents filed with the SEC by the
Company by directing a written request to: Mast Therapeutics, Inc.
3611 Valley Centre Drive, Suite 500, San
Diego, California 92130, Attn: Investor Relations. Investors
and security holders are urged to read the proxy
statement/prospectus/information statement and the other relevant
materials when they become available before making any voting or
investment decision with respect to the proposed merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
The Company and its directors and executive officers and Savara
and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of the Company and Savara in connection with the proposed
transaction. Information regarding the special interests of these
directors and executive officers in the proposed merger are
included in the proxy statement/prospectus/information statement
referred to above. These documents are available free of charge at
the SEC web site (www.sec.gov) and from Investor Relations at the
Company at the address described above.
Participants in the Solicitation
The Company and its directors and executive officers and Savara
and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of the Company and Savara in connection with the proposed
transaction. Information regarding the special interests of these
directors and executive officers in the proposed merger are
included in the joint proxy statement/prospectus referred to above.
These documents are available free of charge at the SEC web site
(www.sec.gov) and from Investor Relations at the Company at the
address described above.
Forward Looking Statements
The Company cautions you that statements in this press release
that are not a description of historical fact are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements may be identified by
the use of words referencing future events or circumstances such as
"expect," "intend," "plan," "anticipate," "believe," and "will,"
among others. Such statements include, but are not limited to,
statements regarding the structure, timing and completion of the
Company's proposed merger with Savara; the Company's expectations
regarding the capitalization, resources and ownership structure of
the combined organization; the nature, strategy and focus of the
combined organization; the safety, efficacy and projected
development timeline and commercial potential of any product
candidates; and the expectations regarding voting by the Company's
and Savara's stockholders. The Company may not actually achieve the
proposed merger with Savara, or any plans or product development
goals in a timely manner, if at all, or otherwise carry out the
intentions or meet the expectations or projections disclosed in the
Company's forward-looking statements, and you should not place
undue reliance on these forward-looking statements. Because
such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon the Company's current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with stockholder approval of and the ability to consummate the
proposed merger through the process being conducted by the Company
and Savara, the ability to project future cash utilization and
reserves needed for contingent future liabilities and business
operations, the availability of sufficient resources for combined
company operations and to conduct or continue planned clinical
development programs, the timing and ability of the Company or
Savara to raise additional equity capital to fund continued
operations; the ability to successfully develop any of the
Company's or Savara's product candidates, and the risks associated
with the process of developing, obtaining regulatory approval for
and commercializing drug candidates that are safe and effective for
use as human therapeutics. Risks and uncertainties facing the
Company are described more fully in the Company's periodic reports
filed with the SEC available at www.sec.gov. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date on which they were made. The Company undertakes
no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they were
made, except as may be required by law.
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SOURCE Mast Therapeutics, Inc.