We are leveraging the ACC technology platform to develop a treatment for Hypoparathyroidism, a rare endocrine disorder characterized by decreased function of the parathyroid glands with underproduction of the parathyroid hormone. This metabolic disease can lead to low levels of calcium in the blood (hypocalcemia), high levels of calcium in the urine (hypercalciuria) as well as bone, muscular and neurological abnormalities. The condition can be inherited (primary Hypoparathyroidism), but is more often encountered after thyroid or parathyroid gland surgery (secondary Hypoparathyroidism). Currently, there are no FDA-approved calcium-supplement drugs indicated for the treatment of Hypoparathyroidism, which affects approximately 180,000 people word-wide.
Amorphical’s ACC clinical development program for Hypoparathyroidism includes a completed phase I study conducted at Rambam Medical Center in Israel. The preliminary results indicated that ACC was generally well tolerated and led to normalized calcium blood and urine levels after reducing the calcium dose by half for all subjects.
Currently (September 2017), following the FDA approval states that our IND application is cleared to proceed with the Phase II/III Clinical Trial, Amorphical is preparing to execute a multicentre global study to evaluate the safety and efficacy of ACC as a treatment of hypocalcemia associated with hypoparathyroidism
For more information on the study results, please contact us.