Azelon Pharmaceuticals, Inc., a biopharmaceutical company developing treatments for osteoporosis, has completed phase II a trial comparing nasal spray ZT-034 to Forteo administered by subcutaneous injection and placebo in women with low bone mass. Following data collection and analysis, the clinical results are expected in July.

Few alternatives are available for women who seek anabolic treatments that can build new bone. Parathyroid hormone (PTH) analogs such as teriparatide are an important but underutilized therapeutic option for osteoporotic patients at high risk of fracture.

“Teriparatide is a very effective therapy for patients with severe osteoporosis and at risk of fractures but it is not widely used, in part because of the need for daily injections in the abdomen or thigh,” said Dr Robert Lindsay, MD, Chief of Internal Medicine, Helen Hayes Hospital New York. “With nasal spray teriparatide, we can reach an effective concentration quickly in a more convenient formulation.  The convenience of nasal spray administration hopefully will encourage many patients who are candidates for teriparatide therapy to begin treatment.”

The phase II study enrolled 130 women with low bone mass in multiple centers across the United States. Patients received one of three treatments: nasal spray ZT-034, Forteo or a placebo. The objective of the study is to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation.  Stimulation of P1NP levels indicates that the amount of teriparatide that has been delivered by the formulation is sufficient to begin the process of increasing bone strength.

“With the last patient visit completed, we have taken an important step toward moving nasal spray ZT-034 into the final stage of clinical testing,” said Joan Lau, PhD, president and CEO.

Azelon owns worldwide rights to ZT-034, a nasal spray formulation of teriparatide (synthetic, PTH1-34) for the treatment of osteoporosis. Teriparatide is an effective bone formation agent but the need for daily injection as required with currently marketed formulations is a barrier to use. As a nasal spray, ZT-034 potentially offers a convenient alternative for patients at high risk of fracture compared to Forteo (rDNA origin, PTH1-34), the standard of care treatment that is delivered via subcutaneous injection. ZT-034 has demonstrated a promising profile in initial human safety and pharmacology studies. Complete efficacy and safety results from the phase II clinical study of ZT-034 are expected in the third quarter of this year.