A Phase III asset in the Amolyt development portfolio has the potential to significantly address unmet needs in patients with chronic hypoparathyroidism.
Through this acquisition, Alexion and AstraZeneca will be able to develop their rare disease portfolio beyond complement inhibition, building on their success in bone metabolism and rare endocrinology. AstraZeneca declared today that it has finalized a deal to buy Amolyt Pharma, a biotechnology business in the clinical stages that specializes on creating cutting-edge therapies for uncommon endocrine disorders.
In addition to strengthening the late-stage pipeline for AstraZeneca Rare Diseases, the proposed acquisition will add eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a unique mechanism of action intended to address important therapeutic objectives for hypoparathyroidism, to the company’s bone metabolism portfolio. Furthermore, Alexion is excited to welcome talent from Amolyt Pharma.
Significant dysregulation of calcium and phosphate is caused by a lack in parathyroid hormone (PTH) synthesis in patients with hypoparathyroidism. This dysregulation can result in life-altering symptoms and problems, including chronic kidney disease.With an estimated 115,000 cases in the US and 107,000 cases in the EU, mostly in women, it is one of the most common uncommon diseases known to science.
Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: “Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency. As leaders in rare disease, Alexion is uniquely positioned to drive the late-stage development and global commercialisation of eneboparatide, which has the potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation. We believe this programme, together with Amolyt’s talented team, expertise and earlier pipeline, will enable our expansion into rare endocrinology.”
Thierry Abribat, Chief Executive Officer, Amolyt Pharma, said: “We enthusiastically welcome the proposed acquisition of Amolyt by AstraZeneca, an organisation that shares our dedication to delivering life-changing treatments to people living with rare diseases. This agreement offers the opportunity to meaningfully advance our pipeline therapies. Strong Phase II data suggest eneboparatide has the potential to improve outcomes for patients and to shift the treatment paradigm for hypoparathyroidism, and we look forward to seeing the continued advancement of the Phase III trial.”
Eneboparatide is a PTH receptor 1 (PTHR1) agonist with a unique mode of action that has been logically created to address hypoparathyroidism’s therapeutic objectives.According to Phase II results, eneboparatide was able to normalize serum calcium levels and may be able to do away with the need for daily calcium and vitamin D supplements. The results indicated that eneboparatide normalized the calcium in the urine of persons with hypercalciuria and chronic hypoparathyroidism. Eneboparatide also maintained bone mineral density in hypoparathyroidism individuals, which is a significant potential advantage in people at risk for osteopenia or osteoporosis.
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