To date, all trial participants have reached the six-month stage, and one out of four have completed the full 12-month study.
“With an urgent need for a new treatment for Lupus which is safe and effective, we are observing an ever increasing focus from the market, the scientific community and patient groups on Lupuzor as we get closer to completing this pivotal Phase 3 study,” Tim McCarthy, chairman of ImmuPharma, said in a press release.
After the trial completion, the company expects to gather sufficient safety and efficacy information to support a regulatory submission to the responsible entities in the United States and Europe.
Lupuzor, also known as IPP-201101 or rigerimod, was designed to modulate the activation of auto-reactive T-cells — cells that attack the body’s own tissues. Contrary to other immune-modulating drugs, the approach allows healthy immune cells to remain active, avoiding foreign attacks and potential infections.
Initiated in June 2016, the Phase 3 clinical trial of Lupuzor (NCT02504645) is being conducted in 30 clinical centers around the world, with 200 lupus patients participating. The study is testing the safety and efficacy of Lupuzor in combination with standard of care therapies, compared to standard of care alone.
Participants were randomly assigned to receive either 200 micrograms of Lupuzor under the skin, or a placebo, every four weeks.
At the time of the analysis, on September 15, 2017, all trial participants had passed the six months of treatment, and 26 percent had completed the planned 52-weeks of the study. The findings support the safety of Lupuzor in lupus patients, which is in accordance with previous results from a Phase 2b study (2007-004892-21).
In the coming months, the company expects all participants will reach the 12-month milestone. Top-line results to be released in the first months of 2018 are expected to support a marketing submission to the regulatory entities.
The U.S. Food and Drug Administration (FDA) has granted the drug fast-track designation, which expedites the approval process by shortening review periods. The FDA also approved a Special Protocol Assessment (SPA) for the drug’s clinical trials, which means the regulatory agency will accept the trials’ results if they are positive.
“We are delighted with the progress of the Lupuzor Phase 3 trial and are looking forward with confidence and planning for a successful outcome for the study,” Robert Zimmer, MD, PhD, president and chief scientific officer of ImmuPharma, said in another press release.
“In consultation with our regulatory advisors, we are now completing the required regulatory dossiers to be submitted to the FDA and EMA as part of their approval process. We are keen to ensure that there are no delays in submission to enable us to fully exploit our ‘fast track’ status, previously granted by the FDA, so that the Company’s package will be reviewed within 6 months of submission,” Zimmer added.