Claritas Pharmaceuticals Inc V.CLAS.H

From F&Q

[whisky11]

The immediate next step is to complete a Phase 1 clinical study to demonstrate that R-107 is safe in humans. This will be followed by Phase 2 and Phase 3 clinicals studies. It is anticipated that the FDA will allow an expedited clinical development pathway for R-107 in this indication.

• R-107 is Phase 1 Ready Right Now: To date, the development of R-107 has been largely funded by approximately $15 million of federal funds that were provided to Salzman Group under a grant provided by the U.S. Department of Health and Human Services.  In addition to this $15 million of federal funding, Salzman Group also invested approximately $5 million of its own funds in the preclinical development of R-107. At this point all pre-IND work is complete, including safety studies in two large animal species.
• Phase 1 Clinical Study: Claritas plans to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Administration (FDA) in support of the first-in-human Phase 1 clinical study. This Phase 1 study of intramuscular R-107 will be conducted at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia.