The clinical trial: “A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia (ACH)” will have a new cohort of up to 60mg/kg. This information was obtain in the clinicaltrial.gov page.
Cohort 4 has recently begun with a 30mg/kg/subcutaneous injection daily. And now, a cohort 5 is planned too.
Cohort: is any group of people who are linked in some way and followed over time.
BMN-111 Phase 2
Estimated Primary Completion Date:December 2018 (Final data collection date for primary outcome measure)
Estimated Study Completion Date: January 2019
Experimental: BMN 111 – Subcutaneous Injection, open-label sequential cohort dose-escalation study. BMN 111 will be administered as a morning dose in one of the following daily dosing regimens:
• Cohort 1: 2.5 microgram/kg, Cohort 2: 7.5 microgram/kg, Cohort 3: 15.0 microgram/kg, Cohort 4: 30.0 microgram/kg and Cohort 5: up to 60.0 microgram/kg
Phase 3 will probably start in the first trimester of 2016. The inclusion and exclusion criteria for phase 3 have not been revealed yet.