• Response to treatment at Month 18 as measured by the Neurologic Impairment Score - Lower Limb (NIS-LL) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Change from Baseline to 18 months in the Total Quality of Life (TQOL) score, as measured by the Norfolk QOL-DN. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  

• Change from Baseline through Month 18 in "+7 composite score" as measured by nerve conduction studies (NCS), vibration detection threshold (VDT) and heart rate response to deep breathing (HRDB) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Change from Baseline through Month 18 in heat pain and cooling thresholds as measured by Quantitative Sensory Testing (QST) utilizing CASE IV [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Change from Baseline through Month 18 in modified Body Mass Index (mBMI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• TTR stabilization through Month 18. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  

Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.