Skye Biosciences (NASDAQ: SKYE) has announced that the Cohort Review Committee (CRC) has approved opening the second cohort of the CBeyond Part C Expansion study of nimacimab in obesity, based on favorable safety data from the first four participants in Cohort 1.
According to Skye, the CRC approved enrollment in Cohort 2 (600 mg IV) based on a favorable safety review of the first participants who completed four weeks of treatment in Cohort 1 (400 mg IV).
In a statement, Punit Dhillon, President and CEO of Skye, commented, “CRC approval to open Cohort 2 and escalate the dose to 600 mg IV once-weekly is an important step in the understanding of nimacimab’s superior safety profile versus small molecule CB1 inhibitors, and importantly provides an opportunity to obtain additional safety and PK data at these higher drug exposures. 400 mg IV is the highest dose we have ever tested with nimacimab and we are encouraged that no neuropsychiatric adverse events have been reported to date. Enrollment into the Expansion Study continues to progress well, and we look forward to evaluating the PK profile of these higher doses once they are available.”
