Claritas Provides Update Regarding Phase 1 Clinical Study
18 November 2021 - 11:15PM
Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF)
(the "
Company" or "
Claritas")
today provided an update regarding the expected time to completion
of its Phase 1 clinical study of R-107, the Company’s proprietary,
liquid, nitric oxide-releasing compound (the “
Phase 1
Study”).
Phase 1 Study to be Completed at
Scientia Clinical Research
Claritas is focused on completing the Phase 1
Study as quickly as possible. Due to the inability of CMAX Clinical
Research (“CMAX”) to provide an assurance that the
Phase 1 Study will be completed during Q1 2022, Claritas has
terminated its agreement with CMAX, and has entered into a Clinical
Trial Research Agreement with Scientia Clinical Research
(“Scientia”), a state-of-the-art clinical trials
facility with a focus on first-in-human and first-in patient
clinical studies located in Sydney, Australia. Scientia possesses
world-class clinical trial expertise and conducts a wide range of
clinical trials, with a focus on early-stage clinical research.
Scientia will use best efforts to complete the Phase 1 Study during
Q1 2022.
“The Australian Taxation Office provides a
rebate to Australian companies of 43.5% of qualifying R&D
expenditures. The availability of such R&D rebates was an
important factor in our decision to have our Australian subsidiary,
Claritas Australia Pty. Ltd., conduct the Phase 1 Study in
Australia. However, many other companies are conducting clinical
trial research in Australia for the same reason, creating an
increased demand for services and consequent delays in completion
of clinical studies. We were unwilling to delay the completion of
the Phase 1 Study beyond the end of Q1 2022, and for this reason we
have moved the Phase 1 Study from CMAX in Adelaide to Scientia in
Sydney,” stated Robert Farrell, President and CEO of Claritas. “At
Scientia we will be able to complete the Phase 1 Study by Q1 2022.
Following completion of the Phase 1 Study, we will initiate our
planned Phase 2a study of R-107 in treatment of pulmonary arterial
hypertension (“PAH”), and apply for U.S.
governmental grant funding for the further development of R-107 for
treatment of COVID associated lung disease.”
About Claritas PharmaceuticalsClaritas
Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company
focused on developing and commercializing therapies for patients
with significant unmet medical needs. Claritas leverages its
expertise to find solutions that will improve health outcomes and
dramatically improve people's lives.
- Website
Home: https://claritaspharma.com/
- News and
Insights: https://claritaspharma.com/news/
-
Investors: https://claritaspharma.com/investors
Cautionary StatementsNeither
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
unfavorable results. Claritas undertakes no obligation to comment
on analyses, expectations or statements made by third parties, its
securities, or financial or operating results (as applicable).
Although Claritas 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 Claritas’ 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.
Claritas 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 InformationRobert
FarrellPresident, CEO(888) 861-2008info@claritaspharma.com
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