Amolyt Pharma Raises Funding to Help Develop Eneboparatide

Funding will be used in Phase 3 testing of treatment, formerly called AZP-3601

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by Patricia Inácio, PhD |

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Amolyt Pharma has raised €130 million (roughly $138 million) to support the clinical development of eneboparatide, previously AZP-3601, the company’s experimental therapy for hypoparathyroidism.

The funding will be used in Phase 3 testing of the treatment and will also help develop AZP-3813 for acromegaly, which occurs when too much growth hormone is produced, according to a press release.

“We are very pleased to complete this large Series C financing, which will enable us to build on our momentum with eneboparatide and accelerate the growth of Amolyt Pharma and its pipeline globally,” said Thierry Abribat, PhD, founder and CEO of Amolyt.

A feature of hypoparathyroidism is low parathyroid hormone (PTH) levels, which leads to a shortage of calcium and vitamin D and a rise in phosphorus.

Eneboparatide works to mimic PTH’s function. Since excessive PTH can have detrimental bone effects, eneboparatide was designed to be quickly eliminated.

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The therapy’s safety and effectiveness were assessed in adults with hypoparathyroidism in a Phase 2 trial. Twelve hypoparathyroidism patients received subcutaneous (under-the-skin) injections of eneboparatide once a day for four weeks at a starting dose of  20 micrograms (mcg).

During this period, both calcium and vitamin D supplements were progressively discontinued.

Data from this first group also showed eneboparatide normalized calcium levels, with more than 80% of patients being able to discontinue standard supplement therapy. Urinary calcium levels, often elevated in hypoparathyroidism patients, were also normalized.

A second group of 16 patients were given eneboparatide over a similar period. Dosing began at 10 mcg that could be increased to 20 mcg after two weeks. Patients were able to adjust their daily dose to a maximum of 80 mcg in a two-month extension period.

After three months, 93% (13 of 14 participants) had stopped taking both vitamin D and calcium. Blood calcium levels remained within the target range.

The 24-hour urinary calcium was rapidly normalized in all but one patient, including in those with urine calcium levels at the start of the study.

Also, bone turnover (when bone is reabsorbed followed by replacement with new bone) improved, as shown by normalized levels of P1NP and CTX markers.

The financing was led by Sofinnova Partners and co-led by Intermediate Capital Group (ICG).

“With its unique mechanism of action, Amolyt’s lead compound eneboparatide has the potential to significantly improve the lives of patients with hypoparathyroidism,” said Sofinnova Crossover I fund partner Cédric Moreau, who will join Amolyt’s board of directors. “With this Series C financing, we believe that Amolyt’s seasoned and passionate management team will be well-positioned to further evaluate eneboparatide’s differentiated profile through late-stage development and continue to grow its internal pipeline. We are committed to helping Amolyt become a leader in the rare endocrine space.”

Toby Sykes, managing director at ICG, will also join the board. A number of other investors participated in the funding round.

“We are thankful to Sofinnova Partners and ICG for co-leading this financing round, and to all our new and existing investors for their confidence in our team and for their support of our strategy to build a global and sustainable rare disease company. This investment will allow us to continue working tirelessly on bringing novel, life-changing treatments to patients with rare endocrine and related diseases,” Abribat said.