Ascendis Pharma A/S Announces Dosing of Subjects in Phase 1 Trial of TransCon PTH
The single and multiple ascending dose phase 1 trial is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of TransCon PTH in healthy adults. The trial evaluates single ascending doses and ten multiple daily doses of TransCon PTH.
“This phase 1 trial will provide us key insights regarding the potential of TransCon PTH as a treatment for hypoparathyroidism. By replacing PTH at physiological levels, we have designed TransCon PTH to normalize serum and urinary calcium levels, as well as serum phosphate levels, and to improve quality of life,” said
About Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of PTH resulting in low calcium and elevated phosphate levels in the blood. In the short term, symptoms include weakness, muscle cramps, abnormal sensations such as tingling, burning and numbness (paresthesias), loss of memory, impaired judgment, and headaches. This complex disorder can increase the risk of major long-term complications, such as extraskeletal calcium deposition, including within the brain, the kidneys, and the lens of eye, leading to impaired renal function and quality of life.
Hypoparathyroidism affects approximately 77,000 patients in the U.S., the majority of whom develop the condition following damage or accidental removal of the parathyroid glands during thyroid surgery.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) insights we may obtain from our Phase 1 study of TransCon PTH, (ii) whether we can advance TransCon PTH directly into a Phase 3 pivotal program following our Phase 1 study of TransCon PTH, (iii) our potential to become a leading, integrated rare disease company; (ii) our product pipeline; (iv) our ability to apply the TransCon technology platform to build a leading rare disease commercial company and (v) our expectations regarding our ability to create therapies with potential for best-in-class efficacy, safety and/or convenience. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the
Internal contact:Scott T. Smith Chief Financial Officer (650) 352-8389 ir@ascendispharma.com Investor contact:Patti Bank Westwicke Partners (415) 513-1284 patti.bank@westwicke.com Media contact:Ami Knoefler SparkBioComm (650) 739-9952 ami@sparkbiocomm.com