Claritas (Formerly Kalytera Therapeutics) Cites Breakthrough Data by Massachusetts General Hospital and Others Demonstrating the Effectiveness of Nitric Oxide as a Potential Therapy for COVID-19 Infection and Validating the Potential of R-107 in this Indication

SAN FRANCISCO, March 02, 2021 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (formerly Kalytera Therapeutics, Inc.) (TSX VENTURE: KLY and OTC: KALTF) (the "Company" or "Claritas") today announced that compelling data demonstrating that nitric oxide achieved viral clearance in severe and critical COVID-19 patients validates the potential of the Company’s proprietary nitric oxide releasing compound, R-107, as a therapy for coronavirus and COVID-19 infection.

Breakthrough Data with Nitric Oxide in COVID-19

R-107 is a nitric oxide-releasing compound. Nitric oxide is being evaluated by both industry and academic groups as a potential treatment for COVID-19 infection. Initial data from some of these studies have been announced. These data are exceptionally positive.

• Data from a clinical study conducted by Massachusetts General Hospital (“Mass General”) in pregnant patients with severe and critical COVID-19 infection demonstrated viral clearance by 22 days after COVID-19 diagnosis in 5 of 6 patients who received inhaled nitric oxide gas, but no other antiviral medication.¹
  
  

• In vitro data from studies conducted by Know Bio, LLC demonstrate that nitric oxide can inhibit viral reproduction of SARS-CoV-2, the coronavirus that causes COVID-19. Multiple nitric oxide-releasing compounds were tested against wild type SARS-CoV-2 virus. The result was a greater than 99.9% reduction in virus observed after 24 hours, versus virus observed in untreated cells.²
  
  

• Uppsala University in Sweden announced in vitro data demonstrating the dose dependent antiviral effect of nitric oxide on SARS-CoV-2 replication.³ "To our knowledge, nitric oxide is the only substance shown so far to have a direct effect on SARS-CoV-2," stated Åke Lundkvist, a professor at Uppsala University, who led the study.
  
  

• Novan, Inc., a North Carolina based biotech company announced positive in vitro results showing the potential efficacy of nitric oxide as an antiviral against SARS-CoV-2, the virus that causes COVID-19 infection. Novan’s studies were conducted at the Institute for Antiviral Research at Utah State University.
  

The data announced by Mass General are of particular interest. Six pregnant patients with severe and critical COVID-19 infection began rescue therapy with inhaled nitric oxide within 48 hours from hospital admission. The treatment was well tolerated, and no side effects were observed. By day 22, five of the six patients, who received no other antiviral medication, tested negative twice for SARS-CoV-2. All six patients were discharged, and have now delivered healthy, COVID-19 free, infants. These data represent a breakthrough in the potential treatment of COVID-19 infection.

“Based on the positive outcomes observed in the Mass General study, as well as the data from Know Bio’s studies, which have provided definitive evidence that nitric oxide inhibits viral reproduction of SARS-CoV-2, we are convinced that development of R-107 for coronavirus and vaccine-resistant COVID-19 infection should become the Company’s priority,” stated Robert Farrell, Claritas’ President and CEO. “A COVID-19 treatment will be essential to manage illness resulting from vaccine-resistant strains of the virus, as well as potentially providing a rescue therapy for patients who did not receive a vaccine or for whom the vaccine was not effective. R-107, if approved, may play an important role in reducing overall COVID-19 mortality rates.”

Professor Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society is working with Claritas, and has read and approved of the scientific disclosure in this news release. Professor Cuzzocrea has deep expertise regarding the medical use of nitric oxide and nitric oxide donors, and has published more than 600 papers on nitric oxide. He has conducted research and experiments with nitric oxide and nitric oxide donors since 1994, and worked closely as an advisor with the Salzman Group team that designed and invented R-107.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

About Claritas Pharmaceuticals

Claritas Pharmaceuticals, Inc. ("Claritas") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing and delivering innovative human therapeutics. 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.

• 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

¹ Mass General study shows the benefits of inhaled nitric oxide therapy for pregnant patients with severe and critical COVID-19: https://www.massgeneral.org/news/press-release/nitric-oxide-benefit-pregnant-covid-patients
² KNOW Bio Announces Breakthrough Nitric Oxide Discovery to Combat COVID-19 – First definitive demonstration of nitric oxide efficacy against the SARS-CoV-2 virus – KNOW Bio, LLC press release – Sep 10, 2020
³ Redox Biology, 2020 Oct; 37: 101734, Mitigation of the replication of SARS-CoV-2 by nitric oxide in vitro, Dario Akaberi, Janina Krambrich, Jiaxin Ling, Chen Luni, Göran Hedenstierna, Josef D. Järhult, Johan Lennerstrand, and Åke Lundkvist