Strategic Collaboration
Conservation of Capital: To conserve capital, Claritas is collaborating with Salzman Group, Ltd. of Israel (“Salzman Group”) and other companies for the manufacture of R-107, and the design and completion of clinical studies to demonstrate the safety and efficacy of R-107 in several diseases.
Collaboration with Salzman Group: Claritas has entered into a strategic collaboration under which Salzman Group will make available to Claritas its full capabilities, including expertise in working with nitric oxide and nitric oxide releasing compounds. Specifically, Salzman Group will provide a platform of services, including expertise in the manufacture of R-107, design of clinical studies, and interactions with regulatory bodies in the U.S., Australia, and the EU. Significant economic and process benefits that Claritas will realize from this collaboration include:
Economic Benefits: Access to Salzman Group’s research scientists and drug development experts on a part time basis provide a lower cost structure than Caritas would incur by hiring its own team of such experts.
Manufacturing Know-How: 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 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.
Legacy Knowledge: Working with the same team that successfully completed the preclinical work required to advance R-107 into human clinical testing ensures continuity of that work in the most efficient and risk-avoidant manner possible.
Collaborations with Scientia Clinical Research and DataPharm in Sydney, Australia
The Australian R&D Rebate: Claritas is initiating clinical studies in Sydney, Australia in order to receive the 43% R&D cash rebate that is provided by AusIndustry to encourage companies to engage in research and development work benefiting Australia.
Next Steps with Scientia and DataPharm: The immediate next step in the development of R-107 will be completion of a first-inhuman Phase 1 clinical study. This Phase 1 clinical study will be conducted at Scientia Clinical Research in Sydney, and will be managed by DataPharm, an Australian contract research organization.