APVO210, an antibody to treat autoimmune and inflammatory diseases such as lupus, has entered a Phase 1 clinical trial to test its safety and tolerability in healthy volunteers, announced its developer Aptevo Therapeutics.
Conducted in Australia, the study (NCT03768219) is meant to determine APVO210’s optimal dose and regimen for use in future studies.
Clinical trials have extensively explored interleukin-10 (IL-10), an important suppressor of inflammation, as a potential approach to prevent autoimmune and inflammatory reactions. However, these studies failed to show clinical benefit, which researchers attribute to the possible stimulatory effect of the molecule on some immune cells, which reduces its therapeutic effects.
To address this issue, Aptevo designed APVO210 to deliver a modified form of IL-10 to immunosuppressive cells only, impairing the signaling molecule from activating other kinds of immune cells.
“APVO210 has the potential to harness the desired anti-inflammatory effects of IL-10 without promoting concomitant undesired pro-inflammatory responses,” Jane Gross, PhD, chief scientific officer of Aptevo, said in a press release. “We are very excited to begin our clinical development program for APVO210 to determine if the preclinical properties observed to date can be replicated in a clinical setting.”
The ongoing Phase 1 trial will be conducted in two parts. First, up to 64 healthy volunteers will receive a single dose — ranging from 2 mcg/kg up to 320 mcg/kg — of APVO210 or a placebo.
In the second part, the trial will include up to 40 healthy volunteers who will be randomized to a placebo or multiple ascending doses of APVO210, ranging from 40 mcg/kg to 360 mcg/kg, given once or twice a week for more than four weeks.
In this part of the trial, the recommended dose of APVO210, or placebo, will be given for 12 weeks by intravenous infusion to provide detailed long-term data on APVO210’s safety and preliminary efficacy.
Aptevo expects to report preliminary safety data during the third quarter of 2019, and additional results in the fourth quarter of 2019.
“If demonstrated to be safe and effective in a clinical setting, we believe that APVO210 could represent a potentially groundbreaking new approach in the treatment of various IL-10-mediated autoimmune diseases,” said Scott Stromatt, MD, chief medical officer of Aptevo.