Abstract: Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Type:
Grant
Filed:
March 22, 2023
Date of Patent:
May 7, 2024
Assignee:
Radius Health, Inc.
Inventors:
Greg Williams, Naveen Palwai, David Hanley
Abstract: Disclosed herein is a method of treating cardiomyocyte reperfusion injury associated with an ischemic myocardial event. The method includes administering to a subject in need thereof an effective amount of a abaloparatide to a subject in need thereof prior to performing reperfusion, concurrent with performing reperfusion, or both. Further provided is a method of treating cardiomyocyte reperfusion injury associated with cardiac transplant. The method includes contacting a donor heart with an effective amount of abaloparatide.
Type:
Application
Filed:
January 5, 2024
Publication date:
May 2, 2024
Applicant:
Radius Health, Inc.
Inventors:
Beate Klara Maria Mannstadt, Bruce Mitlak
Abstract: Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Type:
Grant
Filed:
October 21, 2022
Date of Patent:
December 5, 2023
Assignee:
Radius Health, Inc.
Inventors:
Greg Williams, Naveen Palwai, David Hanley
Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.
Abstract: Disclosed herein is an improved process for preparing abaloparatide. The process generally utilizes solid phase peptide synthesis employing an Fmoc-protection scheme. Incorporating a systematic recoupling step of a glutamine residue (Gln16) has been found to minimize the formation of an undesirable des-Gln16 abaloparatide impurity, which is often obtained in significant quantities in the conventional process.
Abstract: Disclosed herein is an improved process for preparing abaloparatide. The process generally utilizes solid phase peptide synthesis employing an Fmoc-protection scheme. Incorporating a systematic recoupling step of a glutamine residue (Gln16) has been found to minimize the formation of an undesirable des-Gln16 abaloparatide impurity, which is often obtained in significant quantities in the conventional process.
Abstract: Provided herein are methods of accelerating long bone fracture healing that include daily administration of a therapeutically effective amount of abaloparatide in combination with a surgical intervention for a long bone fracture. The daily administration is initiated prior to, at the time of, or following, surgical intervention for the long bone fracture and accelerates long bone fracture healing.
Type:
Application
Filed:
July 3, 2023
Publication date:
November 2, 2023
Applicant:
Radius Health, Inc.
Inventors:
Beate Klara Maria Mannstadt, Bruce Mitlak
Abstract: Provided herein are methods for increasing bone mineral density, treating osteoporosis and the like, that include administration of abaloparatide in combination with denosumab.
Type:
Application
Filed:
July 22, 2022
Publication date:
October 19, 2023
Applicant:
Radius Health, Inc.
Inventors:
Gary Hattersley, John A. Yates, Bruce Mitlak
Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.
Abstract: Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Type:
Grant
Filed:
April 1, 2021
Date of Patent:
October 10, 2023
Assignee:
Radius Health, Inc.
Inventors:
Greg Williams, Naveen Palwai, David Hanley
Abstract: Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Type:
Application
Filed:
March 22, 2023
Publication date:
September 7, 2023
Applicant:
Radius Health, Inc.
Inventors:
Greg Williams, Naveen Palwai, David Hanley
Abstract: Disclosed are PTHrP analogue formulations for transdermal delivery of a therapeutically effective amount of a PTHrP analogue, as well as transdermal patches prepared using these formulations, methods of preparing the disclosed formulations and patches, and methods of using these formulations and patches to treat osteoporosis, osteopenia, osteoarthritis, and/or bone fracture, improve bone mineral density (BMD), improve trabecular bone score (TBS), and treat, prevent, and/or reduce bone fractures.
Type:
Application
Filed:
November 4, 2022
Publication date:
September 7, 2023
Applicants:
Radius Health, Inc., Kindeva Drug Delivery L.P.
Inventors:
Gary Hattersley, Alan Harris, Jamal Saeh, Ehab Hamed, Kenneth Brown, Daniel Dohmeier, Joan Moseman, Ying Zhang, Lisa Dick
Abstract: The present disclosure is directed to methods (e.g., in vitro methods) for detecting the presence of neutralizing antibodies to PTH or PTHrP analog in a sample. The in vitro method comprises the steps of obtaining a sample from a subject; contacting the sample with a cell; measuring cyclic adenosine monophosphate (cAMP) levels; and detecting the presence of neutralizing antibodies, when cAMP levels are reduced relative to a negative control sample without neutralizing antibodies. An in vitro method of detecting the presence of neutralizing antibodies in a sample from a subject treated with Abaloparatide is also provided. Further provided herein is a kit for carrying out the methods described herein comprising components required to carry out the obtaining, contacting, measuring and detecting steps and instructions for use.
Abstract: The present disclosure is directed to methods (e.g., in vitro methods) for detecting the presence of neutralizing antibodies to PTH or PTHrP analog in a sample. The in vitro method comprises the steps of obtaining a sample from a subject; contacting the sample with a cell; measuring cyclic adenosine monophosphate (cAMP) levels; and detecting the presence of neutralizing antibodies when cAMP levels are reduced relative to a negative control sample without neutralizing antibodies. An in vitro method of detecting the presence of neutralizing antibodies in a sample from a subject treated with Abaloparatide, is also provided. Further provided herein is a kit for carrying out the methods described herein comprising components required to carry out the obtaining, contacting, measuring and detecting steps and instructions for use.
Abstract: Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Type:
Application
Filed:
October 21, 2022
Publication date:
February 23, 2023
Applicant:
Radius Health, Inc.
Inventors:
Greg Williams, Naveen Palwai, David Hanley
Abstract: Disclosed herein is a method for preventing or reducing bone fractures in an overweight subject. The method comprises administering to the subject a therapeutically effective amount of an osteoanabolic agent.
Abstract: The present disclosure is directed to methods (e.g., in vitro methods) for detecting the presence of neutralizing antibodies to PTH or PTHrP analog in a sample. The in vitro method comprises the steps of obtaining a sample from a subject; contacting the sample with a cell; measuring cyclic adenosine monophosphate (cAMP) levels; and detecting the presence of neutralizing antibodies when cAMP levels are reduced relative to a negative control sample without neutralizing antibodies. An in vitro method of detecting the presence of neutralizing antibodies in a sample from a subject treated with Abaloparatide, is also provided. Further provided herein is a kit for carrying out the methods described herein comprising components required to carry out the obtaining, contacting, measuring and detecting steps and instructions for use.
Abstract: Provided herein are methods of enhancing spinal fusion and bone formation in subjects with spinal fractures, deformities or instability in the spine. The method includes administering (e.g., subcutaneously or transdermally) a therapeutically effective amount of abaloparatide to the subject.
Type:
Application
Filed:
March 11, 2022
Publication date:
June 23, 2022
Applicant:
Radius Health, Inc.
Inventors:
Beate Klara Maria Mannstadt, Bruce Mitlak
Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.
Abstract: The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.