Ascendis Pharma Bone Diseases A/s

Ascendis Pharma Growth Disorders A/s

Lars Holten-Andersen

Kennett Sprogøe

David Brian Karpf

Thomas Wegge

Guillaume Maitro

Joachim Zettler

Mathias Krusch

Felix Cleemann

Vibeke Miller Breinholt

Kennett Sprogoe

The present invention relates to pharmaceutical compositions comprising a controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate, or solvate thereof, for use in a method of treating, controlling, delaying or preventing a condition which can be treated, controlled, delayed or prevented with PTH, wherein the pharmaceutical composition comprising the controlled-release PTH compound is administered in accordance with a dosage regimen in which dose adjustment in response to hypocalcemia or hypercalcemia is performed in increments of no more than 25%.

Incremental dose finding in controlled-release PTH compounds

The invention provides a method of treating or controlling hypoparathyroidism in a human patient by administering to the human patient a pharmaceutical composition comprising a controlled-release PTH compound or a pharmaceutically acceptable salt thereof. The controlled-release PTH compound comprises a PTH moiety reversibly conjugated to a branched polyethylene glycol carrier. The composition is administered by subcutaneous injection no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered by subcutaneous injection at the same dosing frequency required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period.

Controlled-release PTH compound

The present invention relates to a pharmaceutical composition comprising a PTH compound, wherein after subcutaneous administration the pharmacokinetic profile of the PTH compound exhibits a peak to trough ratio of less than 4 within one injection interval.

PTH compounds with low peak-to-trough ratios

The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.

Dosage regimen for a controlled-release PTH compound

The present invention relates to a combination of a CNP agonist and at least one further biologically active moiety or drug for use in a method for the treatment or prevention of disorders that benefit from stimulating growth, pharmaceutical compositions comprising at least one CNP agonist, preferably controlled-release CNP agonist, wherein the pharmaceutical composition comprises at least one further biologically active moiety or drug, to using these pharmaceutical compositions as a medicament, to their use in the treatment of disorders that benefit from stimulating growth and to methods of preventing or treating a patient having a disorder that benefits from stimulating growth.

Growing community of inventors

Vanløse, Denmark

Lars Holten-Andersen