Azelon Pharmaceuticals has completed a phase 2a trial comparing nasal spray ZT-034 to Forteo administered by subcutaneous injection and placebo in women with low bone mass.
Patients in the phase 2 study, which saw the enrollment of 130 women with low bone mass in multiple centers across the US, received one of three treatments: nasal spray ZT-034, Forteo or a placebo.
The study aimed to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation.
P1NP levels stimulation indicates the amount of teriparatide that has been delivered by the formulation is sufficient to start the bone strength increasing process.
Azelon president and CEO Joan Lau said, "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."
ZT-034 is a nasal spray formulation of teriparatide (synthetic, PTH1-34) for the treatment of osteoporosis, and potentially offers a convenient alternative for patients at high risk of fracture compared to Forteo (rDNA origin, PTH1-34).
The company expects that results from the phase 2 clinical study of ZT-034 will available in the third quarter of this year.
