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2008
28 August 2008: Announcement no. 2, 2008: Zealand Pharma today announced that Dr. David H...
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Product Pipeline
Zealand's Pipeline comprises 1 compound in phase III, 2 compounds in phase II, 3 compounds ...
ZP2307
Zealand’s novel PTH(1-17) analogue, ZP2307, is the smallest PTH agonist with demonstrated anabolic effect in vivo.
Postmenopausal Osteoporosis is caused by the lack of estrogen. Estrogen levels in rats can be reduced experimentally by ovariectomy (OVX). As a consequence of this operation, rats develop osteopenia, which in many aspects resembles human osteoporosis. According to the FDA and EMEA guidelines, the OVX rats is considered the state-of-the-art model for experimental demonstration of efficacy of new investigational compounds. We have shown that ZP2307 reverses OVX-induced bone loss in old female OVX rats as demonstrated by a marked stimulation of Bone Mineral Density (BMD) and mechanical bone strength.
Increased blood calcium levels is considered critical for the predominant adverse effects associated with treatment with PTH(1-34) and PTH(1-84). These include nausea, headache and leg cramps. We have shown that ZP2307 administered in a broad dose range once daily in OVX rats elicited maximal stimulation of bone strength in absence of the marked increases in serum calcium seen with PTH(1-34).
Thus, we expect that ZP2307 will provide effective treatment of osteoporosis but with better tolerability and safety than currently marketed PTH analogues.
Pharmacological studies in ovariectomized (OVX) rats with moderately severe osteopenia showed that ZP2307 over a broad dose range reversed OVX-induced bone loss and increased Bone Mineral Density (BMD) and bone strength.
ZP2307 has entered preclinical development in 2008. Zealand Pharma plans to conduct safety and toxicology studies to enter into Phase I study, designed to evaluate safety, tolerability and pharmacokinetics of ZP2307.
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