ImmuPharma also announced that database lock of the trial is expected by April 6. This milestone prevents unauthorized or unintended alterations to the information obtained during the double-blind study (NCT02504645). This is especially relevant for double-blind trials, in which investigators do not know if they are using the treatment candidate or a placebo.
The 52-week study, which began in June 2016, evaluated the effectiveness and safety of Lupuzor plus standard therapy in SLE patients. The trial was conducted at 30 centers worldwide.
A total of 200 adults were randomly assigned to receive 200 micrograms of Lupuzor or placebo under the skin every four weeks for 48 weeks. All patients also received the standard therapy.
In January 2018, ImmuPharma announced the trial’s completion. Results showed a robust safety profile over one year of treatment with Lupuzor, also known as IPP-201101.
“With the continued robust safety record of [Lupuzor] achieved over this trial, we look forward with confidence to reporting top line results in the near future,” Tim McCarthy, chairman of ImmuPharma, said in a press release.
The company also announced that, following requests from both patients and researchers, it was initiating an extension study with participants from the Phase 3 trial, who will receive Lupuzor plus standard therapy for an additional six months. Data analysis in this follow-up study will be independent from that of the Phase 3 trial, the company said.
Lupuzor is intended to regulate the immune system without affecting healthy cells, allowing them to remain active to fight infections. The investigational medication inhibits the activation of auto-reactive T-cells — a type of white blood cell — which attack the body’s own tissues. ImmuPharma says that Lupuzor’s ability to avoid targeting healthy cells makes it different from other immune-modulating therapies.
ImmuPharma announced the recent updates after they were informed of them by Simbec-Orion, the company conducting the research.
Lupuzor had been granted fast track designation by the U.S. Food and Drug Administration, which is intended to speed up development and approval of new treatments that meet unmet medical needs. The FDA had also approved a special protocol assessment for Lupuzor’s clinical trials, which means the agency will accept the studies’ results if they are positive.