CHARLESTON, SC & SHEFFIELD, UK—AEterna Zentaris Inc., through its wholly-owned subsidiary Aeterna Zentaris GmbH, has initiated a preclinical development program for parathyroid hormone (PTH) fusion polypeptides with delayed clearance, based on intellectual property (IP) exclusively licensed from the University of Sheffield.
The first indication Aeterna plans to pursue, primary hypoparathyroidism, is an uncommon condition in which the body produces abnormally low levels of PTH. PTH is a key regulating hormone essential for calcium homeostasis and renal phosphate clearance, and for maintaining a balance of those two minerals in the body. If left untreated, primary hypoparathyroidism can cause effects like renal dysfunction, muscle cramping, twitching, seizures, and cardiac arrhythmias.
“We are continuing to advance on our stated goal of expanding our pipeline beyond diagnostics with multiple development programs in potentially high-value indications. With our well-established knowledge and expertise in the endocrinology space, we are executing on our goal of adding synergistic assets to our pipeline to execute on our pipeline expansion strategy,” stated Dr. Klaus Paulini, CEO of Aeterna. “We look forward to combining the expertise of the Aeterna scientific team with the University of Sheffield and Prof. Dr. Ross as we work towards our common goal of helping patients suffering from hypoparathyroidism, while also potentially unlocking significant value in this proprietary asset.”
Aeterna will collaborate with Prof. Dr. Richard J. Ross and his laboratory at the University of Sheffield to advance this potential therapeutic being studied for chronic hypoparathyroidism in adults. It uses a proprietary fusion protein consisting of a modified growth hormone binding protein (GHBP) linked to PTH1-34, with the goal of providing PTH1-34 with a delayed clearance of one or two weeks.
This new therapy approach has the potential for self-administration via a pharmaceutical pen, and to help patients maintain normal serum calcium and phosphate levels during chronic use. Aeterna, along with the University of Sheffield, will undertake certain additional confirmatory research studies prior to initiating formal preclinical toxicology and GMP studies, and finalizing plans for the potential initiation of human clinical trials.
“We are excited about the opportunity to work with Aeterna Zentaris to further research on this new concept of delayed clearance PTH molecules and potential therapeutic treatment options. We look forward working with Aeterna to further the development of PTH fusion polypeptides, which I believe have the potential to address an existing unmet medical need in the treatment of hypoparathyroidism, and may also have the potential in certain other conditions such as osteoporosis,” added Ross.
Under the terms of the license agreement, Aeterna gained worldwide rights to develop, manufacture, and commercialize PTH fusion polypeptides covered by the licensed patents for all human uses for an up-front cash payment of £100,000, and milestone payments to be paid upon the achievement of certain development, regulatory, and sales milestones — as well as low single digit royalty payments on net sales of those products, and certain fees payable in connection with sublicensing.
Aeterna will be responsible for development, manufacturing, approval, and commercialization of the licensed products. The company has also engaged the University of Sheffield under a research contract, the results of which will be included within the scope of the license agreement.