At the Endocrine Society’s Annual Meeting, or ENDO 2021, Amolyt Pharma (“Amolyt”) shared positive clinical data from a Phase 1 clinical trial evaluating AZP-3601 for patients with hypoparathyroidism. Although this trial was performed with healthy volunteers, researchers shared that AZP-3601 increased blood calcium levels for 24+ hours. Since hypoparathyroidism is characterized by low levels of calcium in the blood and bones, this data is certainly promising.
So what is AZP-3601? This peptide analog of parathyroid hormone (PTH) works to increase and maintain calcium levels in the blood. This not only helps reduce hypoparathyroidism symptoms, but works to prevent chronic kidney disease (CKD) by prompting the kidneys to absorb additional calcium. According to Amolyt, approximately 80% of patients with hypoparathyroidism are female and the condition raises the risk of osteoporosis. Thus, AZP-3601 is also designed to help maintain bone strength. Want to learn more about AZP-3601 and its available data? Head to the Amolyt website.
In the Phase 1 clinical trial, researchers seek to analyze the safety, efficacy, tolerability, pharmacodynamics, and pharmacokinetics of AZP-3601. The study, which is still ongoing, was initially made up of 4 cohorts. Participant ages ranged from 18 to 60. During the trial, patients either received a placebo or anywhere between 5-40 mg AZP-3601. Patients who received AZP-3601 saw heightened and sustained calcium levels. Additional data will be available later in 2021.
Hypoparathyroidism is a condition caused when the parathyroid glands fail to produce enough parathyroid hormone (PTH). Normally, PTH helps balance levels of calcium and phosphorus in our bodies. Since these vitamins play an important role in how our bodies work properly, unbalanced levels can cause health issues. In this case, hypoparathyroidism causes low calcium levels in the blood and bones, and high levels of phosphorus in the blood. Autoimmune conditions, cancer treatment, low magnesium levels, and surgical interventions can all cause hypoparathyroidism. Symptoms include:
- Brittle nails
- Dry, coarse skin
- Patchy hair loss
- Intense menstrual pain
- Anxiety and depression
- Muscle spasms, aches, and tremors
- Tingling/burning sensation in the toes, lips, and fingertips
- Irregular heartbeat
- Loss of kidney function
Learn more about hypoparathyroidism here.