We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Kalytera Therapeutics Inc | TSXV:KLY | TSX Venture | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.045 | 0.04 | 0.045 | 0 | 01:00:00 |
Highlights
R-107 is a Nitric Oxide-Releasing Compound
R-107 is a liquid, nitric oxide-releasing compound with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.
The License Amendment
Claritas initially licensed R-107 from the Salzman Group for the treatment of COVID-19 and other viral infections under a License Agreement dated July 16, 2020 (the “License Agreement”). Claritas and the Salzman Group have now entered into the License Amendment to include the grant from the Salzman Group to Claritas of an exclusive, worldwide license to develop and commercialize R-107 for the treatment of pulmonary diseases, including PAH and PPHN.
Claritas Will Develop R-107 as a Nitric Oxide Therapy for Treatment of PAH
“R-107 is a technology that transforms nitric oxide therapy from an impractical, expensive, and difficult to administer inhalation therapy, into a practical treatment that can be administered by capsule or by injection,” stated Robert Farrell, Claritas’ President and CEO. “It has been demonstrated that nitric oxide is clinically effective in the treatment of PAH.2 For this reason, we have now acquired exclusive, worldwide rights to develop R-107 as a nitric oxide therapy for PAH.”
Exceptionally Positive Data from the Evaluation of R-107 in a Validated Animal Model of PAH
As previously disclosed, R-107 was evaluated in a validated animal model of PAH. The data from this study are unprecedented in the scientific literature, and suggest that R-107 is a potentially revolutionary new treatment for PAH.
Following are additional details regarding these data:
Mr. Farrell went on to say, “Based on the exceptionally positive data we saw in the validated animal model of PAH, we believe that R-107 could become a best-in-class, front-line therapy for PAH. If we can demonstrate similar data with R-107 in a Phase 2a clinical study in humans, we believe that R-107 will be viewed as a potentially valuable pharmaceutical asset that we might seek to out-license or sell. We will complete our Phase 1 clinical study by Q1 next year, and we expect to complete the Phase 2a study of R-107 in the treatment of PAH in 2022.”
Mr. Farrell concluded, “With the addition of R-107 for treatment of PAH, Claritas now has two programs addressing large commercial markets. In addition to our program developing R-107 for treatment of viral infections, including COVID-related lung disease, we now also have a potential breakthrough product that could provide unrivalled results in treatment of PAH.”
Pulmonary Arterial Hypertension (“PAH”)
PAH is a critical unmet medical need. PAH is characterized by high blood pressure in the arteries of the lungs. It is a serious condition that makes it difficult for blood to flow through the lungs, which, in turn, forces the heart to work harder than normal. It is a chronic and progressive disease. Over time, PAH will worsen, and may limit physical activities. Patients have a poor prognosis and low survival rate. There is currently no cure for PAH, although there are several approved drugs that can ease the symptoms of the disease. However, all of the currently approved drugs have significant side effects that limit their acceptability. The current market for such drugs exceeds $6 billion per year, and the market is projected to grow to $9.8 billion per year by 2027.3
Claritas’ Development Plan for R-107 in PAH is Designed to Expedite the Monetization of this Asset by Year-End 2022.
Claritas expects to complete the Phase 1 clinical study of R-107 in Q1 2022, and complete of a small Phase 2a clinical study of R-107 in hospitalized patients in 2022.
The Phase 2a clinical study will be conducted in Australia in hospitalized patients in the catheterization laboratory to establish proof of concept that R-107 is effective in reducing blood pressure in the lungs. Patients will be on study for 24-hours. Due to the short duration of the study and the relatively small number of patients that will be enrolled in the study, the Company believes that the study can be conducted at a single site, and completed within no more than one-month.
Demonstration of proof of concept could provide the scientific foundation for immediate sale or strategic licensing of the asset on highly favorable terms. If Claritas is able to demonstrate a drop or reversal of blood pressure similar to what was demonstrated in the validated animal model of the disease, the Company believes that R-107 will be viewed as a significantly valuable pharmaceutical asset, and achievement of the Phase 2a endpoints should constitute a major inflection point in value.
Terms of the License Amendment
Under the terms of the License Amendment, Claritas has agreed to provide the following compensation to Salzman Group:
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 focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people's lives.
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
1 Pulmonary Arterial Hypertension Market Size Worth $9.8 Billion By 2027, Grand View Research, February 2020
2 Nitric Oxide and Pulmonary Arterial Hypertension, Glob Cardiol Sci Pract. 2017 Jun 30; 2017(2): 14.: Adrian H. Chester, Magdi H. Yacoub, and Salvador Moncada
3 Pulmonary Arterial Hypertension Market Size Worth $9.8 Billion By 2027, Grand View Research, February 2020
1 Year Kalytera Therapeutics Chart |
1 Month Kalytera Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions