Clinical Trials

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Enobia Pharma is investigating ENB-0040 for potential use in HPP. Phase 2 clinical trials are ongoing in infants with
hypophosphatasia (HPP) and are planned for children with HPP and adults with HPP-related osteomalcia. A Phase 1 safety trial in adult HPP patients has been completed.

Phase I study in adult HPP patients (completed)

Study design
  • 1-month, open-label protocol and tested repeat doses.
  • Patients received an IV ENB-0040 infusion of 3 mg/kg followed by weekly SC injections of 1 mg/kg (n=3) or 2 mg/kg (n=3)

In June 2009, data from a completed Phase 1 safety trial in adults were presented at the Endocrine Society’s Annual Meeting (ENDO 2009)56.


Phase I/II efficacy trial in severely affected infants (ongoing)

Study design
  • 6-month, open-label protocol involving 4 patients with potentially lethal HPP (ages 6-36 mo) with provisions for dose increases based on clinical response and pharmacokinetic (PK) data.

Clinical Trials.gov ID: NCT00744042
Link: www.clinicaltrials.gov/ct2/show/NCT00744042?term=enobia&rank=1

In June 2009, interim data from an ongoing efficacy trial in infants were presented at the Endocrine Society’s Annual Meeting (ENDO 2009)57, 58.


Phase II trial in children

Study design
  • A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Children With Hypophosphatasia (HPP)

Clinicaltrials.gov ID: NCT00952484
Link: http://www.clinicaltrials.gov/ct2/show/NCT00952484?term=hypophosphatasia&rank=2


Future Studies:

A multicenter, baseline-controlled, open-label study in adults with HPP-related osteomalacia.
  • Check back soon for more details