Annexon Touts Final Huntington's Trial Data Confirming No New Safety Issues

Annexon Touts Final Huntington's Trial Data Confirming No New Safety Issues

Annexon Inc ANNX shared final data from the Phase 2 trial for ANX005 in patients with or at risk for Huntington's disease, which causes a progressive breakdown of nerve cells in the brain. 

  • The 28 patients were dosed for six months and followed for three more. The goal of the study was safety and tolerability.
  • ANX005 demonstrated full and durable C1q target inhibition as measured by two biomarkers.
  • Results showed stabilization of disease progression in the overall population for the entire nine months of the study.
  • Related: Annexon's Interim Mid-Stage Results On Huntington's Disease Candidate Fails To Cheer.
  • Three dropouts were potentially linked to the treatment. The adverse events experienced by the three patients included a case of systemic lupus and idiopathic pneumonitis, a type of noninfectious pneumonia. But no serious cases of infection or death were reported.
  • According to the final data release, the case of lupus resolved after treatment stopped, while the idiopathic pneumonitis event "improved" once dosing ceased. 
  • The third patient experienced hemolytic anemia, which was asymptomatic and also resolved with the end of treatment. 
  • Annexon plans to talk with regulators in the U.S. and the EU to discuss the design of a well-controlled confirmatory trial.
  • ANX005 is also tested for amyotrophic lateral sclerosis, Guillain Barré syndrome, and warm autoimmune hemolytic anemia.
  • Price Action: ANNX shares are up 16.3% at $3.78 during the market session on the last check Tuesday.

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