Monday, January 05, 2015

Phase 3 acne program opens for Sarecycline in the US

  • Actavis indicated at the end of 2014 that it will initiate a Phase 3 program of Sarecycline
  • The antibiotic is a dual, narrow-spectrum antibacterial and potent anti-inflammatory activity, being developed for the treatment of acne and rosacea
  • Shortly before the holidays, two large studies were posted to CTG
  • The first study is a 1000 patient US study comparing Sarecycline (1.5mg/kg once daily po) and placebo.  The primary endpoints will be absolute change in inflammatory lesions and Investigator Global Assessment at 12wks and will read out Oct 2015.  The second study is an identical study also being conducted in the US
Comment:  Sarecycline was developed from a collaborative agreement signed by Paratek and Warner Chilcott (now Actavis) in 2007.  The current studies are being led by Actavis; of note we understand Paratek still has rights to Sarecycline ex-US.  Further understanding of plans for development in other regions is required.  The narrow spectrum profile of Sarecycline is expected to limit antibiotic resistance.  Actavis and Paratek have also previously commented on the robust oral bioavailability, and favorable pharmacokinetic properties of Sarecycline.  One aspect of the Phase 3 program that is of note is that dosing is weight based and this could lead to a requirement for multiple dose strengths or scored tablets if approved

This alert is from our UpdatesPlus-Acne and Rosacea service.  UpdatesPlus offers A unique and affordable combination of information monitoring and expert analysis across 14 therapy areas [further information]

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