Novel drug and trial design generate unique clinical supply management challenges. OrthoTrophix began a two-part, phase 2 clinical trial in February 2014. The first part tested the drug’s safety and efficacy in 27 patients with mild to moderate osteoarthritis in both knees. In addition to safety, the study looked at whether the peptide drug reduced pain and improved function.
In this blog post, we will discuss how OrthoTrophix and Sherpa worked through the clinical supply challenges presented by a frozen drug (Download it now).
FROZEN PEPTIDE DRUG TREATS CARTILAGE DEGENERATION
Osteoarthritis affects around 30 million Americans, causing pain and severe disability. Unfortunately, there are few treatments. Many rely on over-the-counter analgesics to manage their pain. Some ultimately opt for joint replacement surgery.
To better help patients, OrthoTrophix is developing a peptide drug designed to regenerate cartilage. The company hopes this approach will restore function.
OrthoTrophix conducted a two-part, phase 2 trial to demonstrate the drug’s safety and efficacy. This required a complex clinical study design that relied on advanced clinical supply logistics. Because the drug for this trial was a frozen liquid, storage, packaging and delivery were quite challenging. In addition, patients in the trial received the active drug in one knee and a placebo in the other. The study required that each patient receive four injections, one week apart. The packaging had to make it easy for physicians to inject the correct knee with the correct agent.
Sherpa Clinical Packaging’s advanced cold chain logistics ensured each vial was kept at the appropriate temperature throughout storage, labeling and delivery to clinical sites. In addition, Sherpa stepped up to the challenge of labeling frozen vials, a difficult task not widely available. To ensure each trial participant always received the drug/placebo in the correct knees, Sherpa designed a simple but sophisticated package that provided color coded and serial number information on each vial.
The close partnership between OrthoTrophix and Sherpa ensured that both arms of the trial were completed without any of the vials getting mixed-up. In addition, the peptide drug proved both safety and efficacy in the Phase II trial. There were no severe adverse events and function was significantly increased in the drug-treated knees.
For an in-depth look intothe OrthoTrophix project, download the full case study.