Ascendis Pharma ($ASND) is aiming to raise at least $112 million (€102 million) to move its long-acting growth hormone through a late-phase trial. The offering is intended to give Ascendis the means to carry out a Phase III growth hormone deficiency study while advancing other candidates that have yet to enter the clinic.
Copenhagen, Denmark-based Ascendis is offloading more than 6 million shares for $19 a pop. That would see Ascendis net $112 million, after costs, although the total could increase if the underwriters take up an option on additional shares. Either way, Ascendis is set to add a considerable sum of money to its cash pile. Ascendis closed out June with €91 million in the bank.
The money will go toward a Phase III trial of TransCon Growth Hormone. Ascendis is set to enroll the first patient in the study by the end of the year. Over the duration of the 52-week trial, Ascendis is looking to show that its once-weekly growth hormone formulation can hold its own against Pfizer’s ($PFE) Genotropin. If its drug triggers comparable improvements in annualized height velocity, Ascendis thinks the compliance benefits of the once-weekly regimen will enable it to take market share.
Ascendis is tackling the Phase III without the support of a larger partner. As such, the Danish drug developer will need deep pockets to activate approximately 100 sites, enroll 150 patients, treat them over the course of a year and package the data up for regulators. Study completion is currently penciled in for December 2018. A clearer picture of how the trial is progressing is due to emerge when Ascendis provides an update on enrollment in the first half of next year.
If the trial is a success, it will provide Ascendis with its first commercial product and raise hopes for its pipeline of assets based on the same TransCon technology. The technology takes a drug and renders it inactive. Once administered, the formulation releases the original active molecule over time. In doing so, Ascendis thinks it can create sustained-release formulations of existing drugs. Some of the $100 million will go toward work to apply the technology to parathyroid hormone and c-type natriuretic peptide.
Ascendis also has partnerships with Genentech and Sanofi ($SNY). Genentech turned to Ascendis for help making a formulation of age-related macular edema drug Lucentis that needs administering as rarely as twice a year. And Sanofi is running preclinical tests on long-acting diabetes treatments.