Halozyme initiates Phase I study of bisphosphonate program

This study will explore the safety, tolerability and pharmacokinetics of subcutaneous (SC) administration of a bisphosphonate plus recombinant human hyaluronidase enzyme (rHuPH20). Currently, injectable bisphosphonates must be administered intravenously.

This Phase I dose ranging clinical trial will assess the safety, tolerability and pharmacokinetics of a bisphosphonate with and without co-administration of rHuPH20 across a range of bisphosphonate concentrations and volumes and various rHuPH20 doses. The study will also compare SC administration of a bisphosphonate plus rHuPH20 to IV bisphosphonate alone.

Jonathan Lim, president and CEO of Halozyme Therapeutics, said: “We are pleased that the first clinical trial is underway for our bisphosphonate program, our third proprietary product development initiative to enter clinical studies. The bisphosphonate program joins insulin, for diabetes, and Chemophase, for superficial bladder cancer, our other two proprietary programs in clinical development.

“The goal of Halozyme’s bisphosphonate program is to provide an alternative dosage formulation that may offer greater convenience, compliance and tolerability to patients for the treatment of osteoporosis.”