Immune Regulation has announced positive results from a Phase I study of its lead compound PIN201104 (‘1104).
First-in-human trial C1104-001 was carried out in healthy volunteers and patients with asthma to evaluate the safety, tolerability and pharmacokinetics of single ascending and repeat doses of ‘1104.
It followed a randomised, double-blind, placebo-controlled, parallel-group design.
The single site study was conducted by Parexel in the UK.
A total of 94 subjects including 16 mild asthmatics were administered with ‘1104 as a single ascending dose up to 8mg or repeat doses of 2mg on a single day, or placebo.
Patients were then followed for 21 days.
Immune Regulation CEO Richard Nagle said: “These results for ‘1104 are a great validation of the safety of our immune-resetting platform.”
The trial confirmed the clean safety profile of ‘1104 seen in pre-clinical studies, with the drug found to have a side effect profile comparable to placebo.
Reported side-effects were generally mild and no serious or severe adverse events were recorded.
No dose-limiting safety or tolerability was reported and no injection site reactions were seen in the small cohort of healthy subjects who received subcutaneous (s.c.) dosing.
The trial’s pharmacokinetic data showed exposure to ‘1104 was in-line with expectations based on pre-clinical work.
It was also similar in both healthy volunteers and mild asthmatics.
Based on the successful Phase I results, Immune Regulation now plans to proceed with a Phase IIa proof of concept study, set to start in the second half of next year.