Investigational therapy AD-214 raised no safety concerns in preliminary studies in non-human primates, and AdAlta, the therapy’s developer, is now planning to launch a Phase 1 clinical trial in humans, the company announced.
AD-214 is a modification of AdAlta’s original lead candidate for the treatment of pulmonary fibrosis (PF), AD-114. AD-214 contains two i-bodies — modified antibodies — that specifically target the protein CXCR4. The therapy is primarily being developed for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
Researchers at AdAlta have now completed three studies in non-human primates. One study tested a single dose of AD-214, while the two others tested multiple doses over the course of a month — tested doses were 10, 30, and 100 mg/kg. The goal of these studies was to evaluate the safety of the compound and its pharmacology (the therapy’s effects and properties).
Results from these studies showed that AD-214 was safe and well-tolerated, with no deaths or adverse events reported. No signs of overt toxicity were seen when AD-214 was given intravenously (into the vein) at the highest dose (100 mg/kg). In addition, researchers saw no changes in body weight, nor in respiratory, cardiovascular, neurological, and ophthalmology tests.
There were, however, some reported increases in white blood cell counts immediately after treatment, but they returned to normal within a day. There were also decreases in the levels of certain blood proteins, such as albumin, which were described as “slight” and “completely reversible.”
Based on these results, the company is planning to advance the development of AD-214 into Phase 1 trials in humans within the first few months of 2020.
Bulk manufacturing of AD-214 for Phase 1 trials was completed and done under Good Manufacturing Practice (GMP) conditions, a requirement for regulatory submissions to the U.S. Food and Drug Administration and other agencies.
“We are pleased to reach both the toxicology and GMP drug substance manufacturing milestones on schedule and with expected results, enabling us to progress AD-214 into safety studies in humans as an important next step in bringing a much-needed new therapeutic option to fibrosis patients, and in demonstrating the safety of the i-body as a platform,” Tim Oldham, managing director and CEO of AdAlta, said in a press release.
“We also look forward to additional pharmacokinetic and pharmacodynamic information from this study in the near future,” he added.