The study was a three-month multi-center open-label design.
#Specialized globe daily 2 trial#
We look forward to results from Cohort 2, which will inform the design of a Phase 3 trial as we work to advance this promising therapeutic peptide through an efficient late-stage development plan.”Īt the end of the treatment period, active vitamin D and oral calcium were discontinued in 90% and 80% of patients, respectively, while mean AdsCa remained within the target range.Ģ4-hour urinary excretion of calcium was rapidly normalized in all cases including in patients with hypercalciuria at baseline.īone turnover biomarkers P1NP and CTX slightly increased after two weeks of treatment and remained within their mid-normal range through the end of the study, consistent with a balanced increase in bone turnover.ĪZP-3601 was well tolerated with no serious adverse events and only mild to moderate adverse events. “The data demonstrate that the mechanism of action of AZP-3601 translates into important potential clinical benefits for patients with hypoparathyroidism, in particular those with or at risk of developing hypercalciuria, osteopenia or osteoporosis, who represent the majority of patients with this disease. “We are very pleased with the compelling results from the first patient cohort of this ongoing trial,” said Mark Sumeray, M.D., chief medical officer of Amolyt Pharma. AZP-3601 was well tolerated and demonstrated a favorable safety profile. Normalization of urinary calcium was rapidly achieved in all patients, including those with hypercalciuria at baseline, together with restoration of balanced bone resorption/formation activity. 12, 2022 (GLOBE NEWSWIRE) - Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced positive efficacy and safety data from the first cohort of its ongoing Phase 2a study of AZP-3601 in patients with hypoparathyroidism at the American Society for Bone and Mineral Research 2022 Annual Meeting (ASBMR), which is being held September 9-12 in Austin, TX.ĭuring three months of treatment with AZP-3601, mean serum calcium levels were maintained within the target range and allowed for the discontinuation of oral calcium and active vitamin D supplementation in most patients.
Company to host Key Opinion Leader webinar today, September 12, at 1:30 pm CT/2:30 pm ET.
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