Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF)
(the "
Company" or "
Kalytera")
today announced that it has initiated a food effect study
(“
Study KAL-07”), as part of its lead product
development program evaluating cannabidiol (“
CBD”)
for the prevention of acute graft versus host disease
(“
GVHD”).
Study KAL-07 is being initiated pursuant to
written guidance received from U.S. Food and Drug Administration
(the “FDA”). The FDA is requiring that the
Company complete a study in healthy volunteers to assess the effect
of food intake on the absorption of oral CBD, prior to initiation
of a Phase 3 registration study. The initiation of Study KAL-07
will satisfy this FDA requirement, and bring the Company’s program
in prevention of acute GVHD another step closer to initiation of
the pivotal registration study.
“Study KAL-07 is an important part of our
overall Phase 2 program,” stated Robert Farrell, President and CEO
of Kalytera. “Our goal is to complete all prerequisite work
required by the FDA so that we can initiate registration testing as
soon as possible. We anticipate that we will complete Study KAL-07
by the end of the second quarter this year.”
Kalytera’s Phase 2 program in prevention of GVHD
consists of three separate clinical studies: (1) Study
KAL-05; (2) Study KAL-07; and (3)
Study KAL-08.
Study KAL-05Study KAL-05 is the
Company’s ongoing open label, multicenter study to evaluate
multiple doses of CBD for the prevention of acute GVHD following
allogeneic hematopoietic cell transplantation, commonly referred to
as bone marrow transplantation. The study is evaluating the PK
profile, safety, and efficacy of CBD at doses of 75, 150, and 300
mg twice daily (“BID”). It is anticipated
that Study KAL-05 will be complete later this year, and will
provide support for the planned Phase 3 registration study required
for regulatory approval by the FDA.
Study KAL-07Study KAL-07, the
“food effect study”, is a double blind, randomized, two period, two
treatment, fixed sequence, crossover (fed versus fasted)
study to evaluate the effect of food on the pharmacokinetics of
CBD, along with robust ECG monitoring in 32 healthy volunteers.
This study is being conducted at a single site in Melbourne,
Australia.
FDA guidelines also require that a proposed new drug be
evaluated for its effects on cardiac rhythm. This evaluation is
typically done in a separate study known as a QT or QTc study. To
save time and expense, Kalytera is including a robust ECG
evaluation of each subject enrolled in Study KAL-07. By including
this evaluation in the design of Study KAL-07, the Company will be
able to complete another critical study evaluation on the pathway
to registration, without having to initiate a separate QT or QTc
study for this purpose.
Study KAL-08Study KAL-08, the
“drug-drug interaction study”, is a second healthy volunteer study
that has been requested by the FDA. This drug-drug interaction
study will measure the effect of certain anti-fungal drugs upon
metabolism of CBD, and the Company anticipates that it will
complete Study KAL-08 during the third quarter this year .
This study will also be conducted at a single site in Melbourne,
Australia.
GVHDPatients receiving bone
marrow transplants are at high risk of developing acute GVHD, a
life-threatening complication that occurs when the transplanted
donor cells attack the patient’s organs, including the skin, GI
tract, liver, lungs, and eyes. It is estimated that up to 50% of
patients who undergo a bone marrow transplant from a sibling donor,
and up to 70% of patients who undergo a bone marrow transplant from
an unrelated donor, will develop some level of GVHD. There are
currently no FDA approved therapies for either the prevention or
treatment of acute GVHD.
Kalytera’s Novel, Proprietary CBD
Formulation for Prevention of GVHDThe CBD drug product
that Kalytera is evaluating for prevention of GVHD is a novel and
proprietary formulation designed to overcome issues of poor oral
bioavailability and stability.
One of challenges seen in development of CBD as
an orally administered pharmaceutical is the issue of poor oral
bioavailability caused by first pass metabolism. First pass
metabolism occurs when CBD is absorbed from the GI tract and is
then delivered to the liver by the portal vein. A
significant fraction of CBD is then metabolized in
the liver before it reaches systemic circulation, thereby
reducing the oral bioavailability of the drug.
To overcome this issue, Kalytera has developed a
formulation of CBD that is intended to by-pass first pass liver
metabolism. Kalytera’s formulation is designed to allow CBD to be
absorbed directly into the circulatory system through the ileum
intestine, without first passing through the liver, thereby greatly
enhancing the oral bioavailability of this CBD formulation.
CBD is also known to be unstable, leading to
drug degradation over time. Stability is a critical quality
attribute directly linked to potency, purity and safety, and
therefore it was important that Kalytera find a way to overcome the
instability of CBD during storage. The company’s novel formulation
is designed to overcome this important issue, and this has been
successfully demonstrated in stability studies conducted by the
Company.
CBD is a non-psychotropic ingredient of cannabis
that does not cause euphoria or cognitive effects. Kalytera is the
exclusive licensee of two issued U.S. patents covering the use of
CBD in the prevention and treatment of GVHD, and is also the
exclusive licensee of pending patent applications in other
jurisdictions for the use of CBD in the prevention and treatment of
GVHD.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. is pioneering the development of CBD
therapeutics. Through its proven leadership, drug development
expertise, and intellectual property portfolio, Kalytera seeks to
establish a leading position in the development of CBD medicines
for a range of important unmet medical needs, with an initial focus
on GVHD and treatment of acute and chronic pain.
Website Home: https://kalytera.co/News and Insights:
https://kalytera.co/news/Investors:
https://kalytera.co/investors/
Cautionary Statements Neither TSX Venture
Exchange nor its Regulation Services Provider (as that term is
defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.
This
press release may contain certain forward-looking information and
statements ("forward- looking information") within the meaning of
applicable Canadian securities legislation, that are not based on
historical fact, including without limitation in respect of its
product candidate pipeline, planned clinical trials, regulatory
approval prospects, intellectual property objectives and other
statements containing the words "believes", "anticipates", "plans",
"intends", "will", "should", "expects", "continue", "estimate",
"forecasts" and other similar expressions. Readers are cautioned to
not place undue reliance on forward-looking information. Actual
results and developments may differ materially from those
contemplated by these statements depending on, among other things,
the risk that future clinical studies may not proceed as expected
or may produce unfavourable results. Kalytera undertakes no
obligation to comment on analyses, expectations or statements made
by third parties, its securities, or financial or operating results
(as applicable). Although Kalytera believes that the expectations
reflected in forward-looking information in this press release are
reasonable, such forward-looking information has been based on
expectations, factors and assumptions concerning future events
which may prove to be inaccurate and are subject to numerous risks
and uncertainties, certain of which are beyond Kalytera's control.
The forward-looking information contained in this press release is
expressly qualified by this cautionary statement and is made as of
the date hereof. Kalytera disclaims any intention and has no
obligation or responsibility, except as required by law, to update
or revise any forward-looking information, whether as a result of
new information, future events or otherwise.
Contact Information Robert Farrell President,
CEO (888) 861-2008 info@kalytera.co
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