Claritas Provides Update Regarding Phase 1 Clinical Study

Rhea-AI Summary

Claritas Pharmaceuticals, Inc. (OTC: KALTF, TSX VENTURE: CLAS) announced a change in its Phase 1 clinical study of R-107 due to delays at CMAX Clinical Research. The company has terminated its agreement with CMAX and signed a new contract with Scientia Clinical Research in Sydney, Australia, which has the requisite expertise to complete the study by the end of Q1 2022. The decision was influenced by the Australian Taxation Office's R&D rebate program. Following the Phase 1 completion, Claritas plans to launch a Phase 2a study targeting pulmonary arterial hypertension (PAH) and seek U.S. grant funding for COVID-related lung disease development.

Positive

• Transition to Scientia Clinical Research expected to expedite Phase 1 study completion by Q1 2022.
• R&D rebates from the Australian Taxation Office may enhance financial efficiency.

Negative

• Delays in the original Phase 1 study at CMAX could reflect project management challenges.
• Increased competition for clinical trial services in Australia may pose future risks.

SAN FRANCISCO and TORONTO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- 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 Pharmaceuticals
Claritas 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 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 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 Information
Robert Farrell
President, CEO
(888) 861-2008
info@claritaspharma.com

FAQ

What is the purpose of the Phase 1 study for R-107?

The Phase 1 study aims to evaluate the safety and pharmacokinetics of R-107 in humans.

When will the Phase 1 study of R-107 be completed?

Claritas expects the Phase 1 study to be completed by the end of Q1 2022.

What are the next steps after the Phase 1 study of R-107?

Following the Phase 1 completion, Claritas plans to initiate a Phase 2a study focusing on pulmonary arterial hypertension.

How does the Australian Taxation Office R&D rebate impact Claritas Pharmaceuticals?

The R&D rebate reduces qualifying research expenditure, potentially improving financial outcomes for Claritas.

What competitive challenges does Claritas face in conducting its clinical trials in Australia?

The increasing demand for clinical trial services in Australia presents risks of delays and resource allocation challenges for Claritas.