Enobia Pharma is investigating A subcutaneous enzyme replacement therapy with affinity for bone that is currently in clinical trials.ENB-0040 for potential use in HPP. Phase 2 A research study that uses consenting human subjects to test the safety and efficacy of new therapeutic interventions and diagnostic tests.clinical trials are ongoing in infants with
A rare, inherited, and sometimes fatal metabolic bone disease characterized by poor bone mineralization and profound skeletal defects.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)
- 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)
- 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.
A research study that uses consenting human subjects to test the safety and efficacy of new therapeutic interventions and diagnostic tests.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, The study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.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:
- Check back soon for more details