Beyond Achondroplasia

Growing together with Clara

New cohort revealed for phase 2 of BMN-111

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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.

One Comment

  1. Thanks for the update. But inworry about timelines and whether to risk it ans wait for Vosoritide or whether to start limb lengthening. 2019 is far……

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