Companies team to develop once-a-day hypoparathyroidism pill
Entera Bio, Opko partner on long-lasting hormone treatment
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Entera Bio and Opko Health are teaming up to develop a once-daily oral treatment for hypoparathyroidism, known as a long-acting parathyroid hormone analog (LA-PTH).
“Preclinical data of oral LA-PTH suggests that this program holds the potential to transform the hypoparathyroidism landscape,” Miranda Toledano, CEO of Entera, said in a press release from the companies.
Each company will have a 50% share in the program, and each will be responsible for half of its development costs. The pair said they expect to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) in late 2026.
Hypoparathyroidism is characterized by low levels of parathyroid hormone (PTH), a signaling protein that plays a crucial role in regulating calcium levels in the body. People with hypoparathyroidism typically develop low calcium levels, which can lead to hypoparathyroidism symptoms ranging from muscle cramps to seizures.
Oral alternative to PTH injection
Calcium and vitamin D supplements have long been the standard of care, but scientists have been developing PTH replacement therapies that aim to treat the disease by delivering a functional version of the PTH protein into the body.
The only PTH replacement therapy approved in the U.S. is Ascendis Pharma‘s Yorvipath (palopegteriparatide), which is administered daily by injection under the skin. Other PTH replacement therapies are in development, but these are also mainly given by injection.
Entera has been working for years to develop an oral alternative. The company was previously developing EB612, an experimental oral therapy designed to deliver a portion of the PTH protein into the body. Early clinical data suggested that the treatment was effective in helping people with hypoparathyroidism reduce their reliance on calcium supplements, but because the naturally occurring form of PTH is unstable in the body, EB612 needed to be taken four times a day.
The new collaboration will use Entera’s oral delivery technology to administer a modified version of the PTH protein developed by Opko. The modified protein is designed to be stable in the body, allowing for once-daily treatment in tablet form.
“We are pleased to expand our successful collaboration with Entera to advance this promising long-acting PTH program for hypoparathyroidism,” said Phillip Frost, MD, chairman and CEO of Opko Health. “Our goal is to provide patients with hypoparathyroidism a more convenient treatment option that eliminates the burden of daily injections while maintaining therapeutic efficacy.”
