Immune Regulation Ltd has reported positive results from a Phase 1 study of its lead compound PIN201104 (‘1104).

Study C1104-001 was a First Time in Human, randomized, double blind, placebo controlled, parallel group study in healthy volunteers and patients with asthma to assess the safety, tolerability and pharmacokinetics of single ascending and repeat doses of ‘1104.

The Phase 1 trial recruited 94 subjects, including 16 mild asthmatics, administered with ‘1104 as a single ascending dose up to 8mg or repeat doses of 2mg on a single day or placebo and then followed for 21 days.

The Phase 1 trial confirmed the clean safety profile of ‘1104 seen in pre-clinical studies, with the drug having a side effect profile comparable to placebo; the majority of events were classed as mild and no serious or severe adverse events were reported. No dose limiting safety or tolerability was reported in the study and no injection site reactions were seen in the small cohort of healthy subjects receiving subcutaneous (s.c.) dosing. Pharmacokinetic data from the trial showed exposure to ‘1104 was in-line with expectations based on pre-clinical work and was similar in both healthy volunteers and mild asthmatics.

Based on these successful Phase 1 results, Immune Regulation is moving forward with a Phase 2a proof of concept study, due to commence in the second half of 2019.

Details of the Phase 1 (C1104-001) study include:

  • Single site study conducted by Parexel in the UK
  • 78 healthy volunteers (HV) and 16 mild asthmatics were enrolled
  • The trial advanced through eleven cohorts of HV (44 active, 22 placebo) with a dose range of 0.02ng to 8mg, administered as a single iv bolus injection.
  • Mild asthmatic patients received single iv doses of placebo, 2mg or 8mg (10 active, 6 placebo)
  • 6 HV (4 active, 2 placebo) received 2mg via a sc injection
  • 6 HV (4 active, 2 placebo) received 3 x 2mg doses 2 hours apart
  • Subjects were followed over 21 days post dose
  • Primary endpoints were safety and pharmacokinetic data

“These results for ‘1104 are a great validation of the safety of our immune-resetting platform. It is exciting to now be embarking upon the next stage of development and the data from this study will inform the preparations and protocols for our Phase 2a trial starting next year,” said Richard Nagle, CEO of Immune Regulation.