Antibe Therapeutics Announces Completion of Validation Studies of ATB-346, Progression to Phase 2 Clinical Trials
21 Dezembro 2015 - 10:45AM
Business Wire
Antibe Therapeutics Inc. ("Antibe") (TSXV: ATE, OTCQX: ATBPF)
announced today the completion of the previously announced
validation studies being performed on the Company's lead drug,
ATB-346. These studies were initiated as a consequence of ATB-346
inducing an elevation of liver enzymes in some subjects taking the
higher doses of the drug (750 and 1500 mg/day), and were aimed at
gaining a better understanding of the drug's potency, absorption,
metabolism and excretion characteristics. The results of these
studies support progression to Phase 2 of development of this drug
in patients with osteoarthritis.
In the first set of studies, as previously announced, the
suppression of the activity of the cyclo-oxygenase (COX) enzyme,
which accounts for the anti-inflammatory and pain-killing effects
of ATB-346 (and all other NSAIDs), was substantially greater and
longer lasting than had been predicted from the monitoring of blood
naproxen levels. NSAIDs are well known to cause liver damage in
some patients when taken at high doses.
In the second set of studies, rats were administered ATB-346, in
which the hydrogen sulfide-releasing portion of the molecule was
'tagged' with a radioactive marker, thereby allowing it to be
tracked after it was administered to each rat. This enabled
monitoring of the excretion of ATB-346 and of its metabolites, and
any accumulation of the drug in particular organs (such as the
liver). There was no significant retention or accumulation of the
radiolabel in any tissues, with more than 99% being excreted in
urine. In rats treated daily with ATB-346 for four days, less than
one-tenth of 1% of the radiolabel remained in the liver 8 hours
after the final administration of the drug. Additionally, levels of
retention of the radiolabel in other organs, including the kidney,
stomach, small intestine and lungs, were extremely low. These
studies also identified a number of metabolites of ATB-346, all of
which were rapidly cleared.
The results of these studies warrant the continuation of
development of ATB-346. They suggest that ATB-346 may be effective
at lower doses than previously expected -- doses that were observed
to be safe and well tolerated in the Phase 1 study. The studies
also suggest that ATB-346 will produce beneficial effects with only
once-daily dosing. Accordingly, Antibe plans to move forward with
Phase 2 studies and will submit an application to Health Canada in
early 2016.
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation.
Antibe's technology involves linking a hydrogen sulfide-releasing
molecule to an existing drug to produce a patented, improved
medicine. Antibe's lead drug ATB-346 targets the global need for a
safer non-steroidal anti-inflammatory drug (NSAID) for chronic pain
and inflammation. ATB-352, the second drug in Antibe's pipeline,
targets the urgent global need for a safer analgesic for treating
severe acute pain, while ATB-340 is a GI-safe derivative of
aspirin. www.antibethera.com.
Antibe's subsidiary, Citagenix Inc., is a leader in the sales
and marketing of tissue regenerative products servicing the
orthopedic and dental marketplaces. Since its inception in 1997,
Citagenix has become the largest source of knowledge and experience
in the Canadian medical device industry when it comes to bone
regeneration and is known as a valuable reference and resource by
clinicians. Operating in Canada through its direct sales teams, and
a network of distributor partnerships around the world, Citagenix
Inc. is active in 15 countries. www.citagenix.com.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) and no stock exchange, securities commission or
other regulatory authority accepts responsibility for the adequacy
or accuracy of this release nor approved or disapproved of the
information contained herein.
Forward-Looking Information
This news release includes certain forward-looking statements
which may include, but are not limited to, information on drug
development. Any statements contained herein that are not
statements of historical facts may be deemed to be forward-looking,
including those identified by the expressions “will”, “anticipate”,
“believe”, “plan”, “estimate”, “expect”, “intend”, and similar
expressions. Forward-looking statements involve known and unknown
risks and uncertainties that could cause actual results,
performance, or achievements to differ materially from those
expressed or implied in this news release. Factors that could cause
actual results to differ materially from those anticipated in this
news release include, but are not limited to, not achieving
commercial revenue from Antibe’s anti-inflammatory and pain drugs,
not achieving the milestone specified in the license agreement,
risks associated with drug development generally, not obtaining
future financing on adequate terms, or at all, anticipated sales
not achieving expected volumes and not obtaining TSX Venture
Exchange final approval for any pending transactions. The sections
on risks contained in the Company's Prospectus and annual
Information Circulars are expressly incorporated herein. Antibe
Therapeutics Inc. assumes no obligation to update the
forward-looking statements or to update the reasons why actual
results could differ from those reflected in the forward-looking
statements except as required by applicable law.
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Antibe Therapeutics Inc.Dan Legault, 416-473 4095Chief Executive
Officerdan.legault@antibethera.com
Antibe Therapeutics (TSXV:ATE)
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