Results of Phase II Study of New Drug for Osteoporosis Treatment-Oral PTH Announced!

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Introduction: Oral parathyroid hormone (PTH 1-34, tablet) EB 613 achieved the main efficacy results in a phase 2 dose study involving low bone mineral density (BMD) postmenopausal women
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The adverse reactions are similar to the injectable PTH 1-34 teriparatide approved for the treatment of osteoporosis
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Teriparatide can reduce the risk of vertebral fractures by 80%, but the route of administration by injection may affect drug compliance, especially for elderly patients
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For this reason, researchers designed this oral dosage form PTH-drug code EB 613
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Arthur C.
Santora, chief medical officer of Entera Bio, MD, reported the results of the six-month study at an oral meeting of the American Association for Bone and Mineral Research (ASBMR 2021 Annual Meeting)
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The investigator said: "If the drug proves effectiveness and safety in a larger phase 3 trial, it may become the first oral bone-building (anabolic) therapy for osteoporosis
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" The research reached the main point.
Research Results-Bone Formation Markers Researchers conducted Phase 2 studies at four locations in Israel from June 2019 to May 2021
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Recruited female participants aged ≥50 years old, entered menopause at least 3 years early, accompanied by osteoporosis or low bone density, average age 61 years, average body mass index 25~27 kg/m^2, average spine T score It is -2.
2~-2.
45
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161 participants were randomly divided into groups.
43 took placebo and the others took oral PTH at doses of 0.
5 mg/d (n=25), 1.
0 mg/d (n=29), 1.
5 mg/d (n=28) , 2.
5 mg/d (n=19) or the dose is titrated from 1.
5 mg/d in the first month to 2.
5 mg/d, the dose in the second month is 2 mg/d, and the dose in the 3-6 months It is 2.
5 mg/d (n=17)
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A period of 6 months
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Compared with patients receiving placebo, the bone formation marker P1NP of women in the drug treatment group increased significantly from baseline to 3 months, reaching the main results of the study
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From the baseline examination to 6 months, the serum level of bone resorption marker CTX decreased by 21%, the serum level of P1NP increased in the first month, and then decreased to the baseline level in the sixth month
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Secondary study results-BMI In the secondary results, compared with the placebo group, women who took 2.
5 mg/d oral PTH for 6 months had a significant increase in BMD [lumbar (3.
8%), total hip (1.
4%), and femur Neck (2.
4%)]
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The researchers said: "The key to this study is that oral PTH once a day may produce the same bone density effect as subcutaneous injection of parathyroid hormone
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Drug safety The safety of oral PTH is the same as that of subcutaneous administration of parathyroid hormone.
The adverse reactions are headache, nausea, dizziness and dizziness, and no hypercalcemia caused by treatment
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Source: American Society of Bone and Mineral Research (ASBMR 2021) Annual Meeting: Presented October 1 and 4, 2021.