Azelon Pharmaceuticals, Inc. announced the completion of a phase 2a trial comparing nasal spray ZT034 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. The phase 2 study enrolled 130 women with low bone mass in multiple centers across the United States. Patients received one of three treatments: nasal spray ZT034, 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. Azelon owns worldwide rights to ZT034, a nasal spray formulation of teriparatide (synthetic, PTH134) 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, ZT034 potentially offers a convenient alternative for patients at high risk of fracture compared to Forteo (rDNA origin, PTH134), the standard of care treatment that is delivered via subcutaneous injection. ZT034 has demonstrated a promising profile in initial human safety and pharmacology studies. Complete efficacy and safety results from the phase 2 clinical study of ZT034 are expected in the third quarter of this year.

Azelon Pharmaceuticals, Inc. has also announced the appointment of Don Hayden as Executive Chairman and Joan Lau as president and CEO of company. Dr. Lau succeeds Brian MacDonald who will remain on as a senior clinical advisor to the company. Hayden spent 25 years with Bristol-Myers Squibb, most recently as Executive Vice President and President, Americas, overseeing two major pharmaceutical units and two healthcare businesses with combined annual sales in excess of $10 billion. Among other board positions, he is Chairman of Insmed and is Lead Director at Amicus . Dr. Lau previously was CEO of Locus Pharmaceuticals, a venture backed drug discovery company. Prior to Locus, she held positions of increasing responsibility at Merck.

Azelon Pharmaceuticals, formerly Zelos Therapeutics, Inc. announced the appointment of industry veteran Don Hayden as Executive Chairman and Joan Lau as president and CEO of Azelon. Dr. Lau succeeds Brian MacDonald who will remain on as a senior clinical advisor to the company. Mr. Hayden spent 25 years with Bristol-Myers Squibb, most recently as Executive Vice President and President, Americas, overseeing two major pharmaceutical units and two healthcare businesses with combined annual sales in excess of $10 billion. Dr. Lau previously was CEO of Locus Pharmaceuticals.