Foralumab Clinical trials

Completed Phase 1 Clinical Trial: Nasal Administration of Foralumab for the Treatment of Multiple Sclerosis

The completed Phase 1 clinical trial of Foralumab in healthy volunteers was a single center, single arm, ascending dose study in which low doses (10, 50 and 250 µg/dose) of Foralumab and placebo were nasally administered for 5 consecutive days. Subjects were monitored for tolerance and immunological effects. The primary endpoint of the Phase 1 study is safety, tolerability and biomarkers of immunomodulation of clinical responses of intra nasally administered Foralumab. Interim results have indicated no drug-related safety issues so far. Topline results were reported on September 10, 2019. All nasal doses were well tolerated. Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 µg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses. These results suggested stimulation of Tregs that are needed to provide clinical benefits. Phase 2a trials will be initiated in Q4 2020 for the treatment of MS.

Completed Phase 1 Clinical Trial: Oral Administration of Foralumab in Healthy Volunteers

An enteric-coated capsule formulation has been developed for oral administration of Foralumab. cGMP manufacturing of clinical trial materials for a Phase 1 study has been completed. The Phase 1 clinical trial for Foralumab in healthy volunteers is a single-center, single-arm, ascending dose study in which low doses (1.25, 2.5 and 5.0 mg/dose) of Foralumab and placebo were orally administered. The primary endpoint of the Phase 1 study was safety and tolerability of oral Foralumab in humans. A Phase 1 trial of the oral, enteric capsule formulation of Foralumab in healthy subjects was initiated on December 2, 2019. Results of the Phase 1 Trial were reported on January 20, 2020 The proprietary oral formulation, comprising the lyophilized and stabilized free-flowing powder of formulated Foralumab encapsulated in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial. Based on the positive outcome of the Phase 1 trial, a Phase 2 trial in Crohn’s Disease patients is expected to begin in Q2/Q3 2021.

Prior Novimmune Clinical Trials using Intravenous Foralumab

Intravenous Foralumab has been studied in one Phase 1 and two Phase 2 clinical trials (Crohn’s disease https://clinicaltrials.gov/ct2/show/NCT00630643 and patients With Acute Renal Allograft Rejection https://clinicaltrials.gov/ct2/show/NCT00805909) conducted by Novimmune. A total of 68 patients were administered Foralumab:

• The short-term tolerability profile of Foralumab was very similar to those reported with other anti-CD3 antibodies and no new emerging concerns have been identified.
• Total daily doses of up to 1mg (~ 500 µg/m2) per patient were generally well tolerated without corticosteroid premedication with reduction in the Crohn’s Disease Activity Index (CDAI) scores in patients.
• The most common adverse events following exposure to Foralumab were Infusion Related Reactions (IRRs).
• A clear reduction of IRRs was observed with steroid pre-medication up to 2.5 mg/dose for 5 consecutive days.
• Therefore, usage of steroid pre-medication allows the administration of higher doses.
• Both the magnitude and duration of CD3 modulation increased in a dose related manner
• No anti-drug antibodies were detected