KLY Kalytera Therapeutics Inc

Claritas Pharmaceuticals, Inc. (formerly Kalytera Therapeutics, Inc.) (TSX VENTURE: KLY and OTC: KALTF) (the "Company" or "Claritas") today announced that it has entered into a Strategic Collaboration Agreement (the Collaboration Agreement”) with the Salzman Group, Ltd. (“Salzman Group”), and is in the process of entering into similar agreements with other companies, to expedite the development of the Company’s breakthrough nitric oxide-releasing compound, R-107.

Strategic Collaboration with Salzman Group

To conserve capital and expedite the development of R-107, Claritas is collaborating with the Salzman Group and other companies for the manufacture of R-107, and for the design and completion of clinical studies to demonstrate the safety and efficacy of R-107 in the treatment of COVID-19, influenza, and other viral infections.

Under the Collaboration Agreement, Salzman Group will make available to Claritas the full capabilities of Salzman Group, including its expertise in working with nitric oxide and nitric oxide releasing compounds. Key members of the Salzman Group include the following research scientists, each of whom has deep expertise with nitric oxide:

• Andrew Salzman, M.D., Chairman of Salzman Group, was, in 1990, the first physician to administer inhaled nitric oxide to a human patient. Dr. Salzman received his undergraduate degree from Yale University and his medical degree from Harvard Medical School. Over the last 25 years, Dr. Salzman has received funding for 135 NIH, DARPA, and BARDA grants totaling $160 million and venture capital funding of $100 million. This funding has supported research and drug development activities in the field of nitric oxide, resulting in 200 scientific publications and 50 patents, spanning work in ischemia-reperfusion injury, intestinal mucosal biology, pulmonary arterial hypertension, autoimmune disease, infectious disease, and mechanisms of pro-inflammatory gene expression. Dr. Salzman has taken 12 of his pharmaceutical inventions from the bench into the clinic.
• Garry Southan, Ph.D., Drug Development Consultant, trained under Nobel Laureate John Vane in the biology and chemistry of nitric oxide; was the Principal Investigator on multiple federal and private R&D projects to develop novel nitric oxide therapies; and is the inventor of the first selective inducible nitric oxide synthase inhibitor. Dr. Southan has worked with Dr. Salzman for 25 years, moving 12 small molecules from the preclinical to clinical phases throughout his career.
• Prakash Jagtap, Ph.D., Medicinal Chemistry Consultant, inventor of the R-107 molecule that led to an award of a USD $84.9 million BARDA contract to develop R-107 as an antidote to chlorine inhalation lung injury. Dr. Jagtap has over 50 patents co-invented with Dr. Salzman, and has co-developed over 8 small molecules with him over his career.
• Yousif Sahly, Ph.D., Salzman Group’s Director of Quality Control, trained at Massachusetts Institute of Technology and has over 25 years of experience in small molecule drug development. Dr. Sahly was the former Director of Metabolism and Pharmacokinetics at Pfizer and Director of Analytical Research and Development at Teva. He oversaw all analytical work on innovative drug development at Teva. Dr. Sahly has led the GMP analytical and GLP bioanalytical studies carried out on R-107 since 2018.
• Gali Guzikevich, Ph.D., Salzman Group’s Director of Quality Assurance, trained at the Weizmann Institute of Science and served as the Director of Quality Assurance and Regulatory Affairs at Teva for over 15 years. Dr. Guzikevich manages the Quality Assurance of both the GMP and GLP Salzman Group laboratories, where R-107 studies have been performed.
• Amos Rosenthal, Ph.D., Salzman Group’s Head of Chemistry, earned his doctoral degree at the Swiss Federal Institute of Technology and his post-doctoral fellowship at Université Toulouse III - Paul Sabatier. Dr. Rosenthal has published several articles in peer-reviewed journals, including in Science. Dr. Rosenthal is leading the GMP process scale-up development of R-107 from gram to kilogram, for commercial production.
• Iris Maimon, Ph.D., Salzman Group’s Director of Drug Development, earned her doctoral degree and post-doctoral degree from the Weizmann Institute of Science. Dr. Maimon’s expertise is in the field of acute lung injury and pulmonary hypertension pharmacology. She has been leading the R-107 preclinical development program since its inception.

Salzman Group will also provide a platform of services, including expertise in the manufacture of R-107, design of clinical studies, and consulting services in connection with Claritas’ interactions with regulatory bodies in the USA, Australia, the UK, and the EU.

The significant benefits that Claritas will realize from this collaboration include:

• Access to Salzman Group’s research scientists and drug development experts on a part-time basis, which will provide a lower cost structure than the Company would incur by hiring its own team of such experts;
• Continuation of in-process work with the same team of Salzman Group researchers that invented R-107, and developed the know-how for the manufacturing process that will enable Claritas to produce R-107 quickly and at scale, without the delays that would result from of transferring this know-how to a third-party contract manufacturer; and
• Continuation of work with the same team that successfully completed the preclinical work required to advance R-107 into human clinical testing.

“Nitric oxide has a well-documented safety profile and has been demonstrated to be effective against a wide variety of viruses,” stated Dr. Andrew Salzman, Chairman of the Salzman Group. “Nevertheless, nitric oxide has not been developed as an antiviral agent due to the fact that it is a gas, and must be administered by inhalation therapy. Our group has worked to design a nitric oxide releasing compound to overcome these issues. This multi-year effort was successful, and resulted in the invention of R-107, which can be administered orally as a capsule, or nasally through use of a nasal spray, or by injection.”

Dr. Salzman continued, “We are delighted to be working with Claritas to develop R-107, not only as a therapy for vaccine-resistant COVID-19 infection, but also as a broad-spectrum antiviral drug for the treatment and possible prevention of future viral outbreaks, including viruses that cause influenza and the common cold.”

Future collaborations with CMAX and PCI Pharma Services

Claritas will initiate human clinical studies in Australia in order to receive the 43% R&D tax credit refund that is provided by the Australian government to encourage companies to engage in research and development work benefiting Australia.

The Phase 1 clinical study of intramuscular R-107 will be conducted at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia. Claritas is in discussions with CMAX regarding a strategic collaboration, under which CMAX will use best efforts to expedite the completion of the Phase 1 study. Claritas is also engaged in similar discussions with PCI Pharma Services, an Australian company that will provide formulation and logistical services in connection with the Phase 1 study.

Professor Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society is working with Salzman Group and 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 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.

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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