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Immunovant, HanAll’s partner, Announces Topline data from Phase 2 for IMVT-1401 in TED

- Immunovant, HanAll Biopharma’s partner, announced the Topline results of Phase 2a clinical trial (ASCEND-GO1) conducted with thyroid eye disease (TED) patients.

- 4/7 patients (57%) improved by ≥ 2 points on the Clinical Activity Score (CAS) and 3/7 patients (43%) achieved a proptosis response

- Results establish first proof of concept for an anti-FcRn antibody in Thyroid Eye Disease


At 9:30 p.m. last night (8:30 a.m. on the 30th, EST), Immunovant, HanAll Biopharma’s global partner for the HL161 novel antibody drug, announced the results of the phase 2a clinical trial (ASCEND GO-1) conducted in North America regarding the treatment effect of HL161 (IMVT-1401) on thyroid eye disease (TED) through real-time web casting.


The multi-center, open-label, single-arm clinical trial evaluated two weekly 680mg subcutaneous doses of IMVT-1401 followed by four weekly 340mg subcutaneous doses of IMVT-1401 in seven adult patients with moderate-to-severe active TED.  A planned eighth patient enrolled in ASCEND GO-2 instead of ASCEND GO-1.  All patients in the trial have completed IMVT-1401 treatment and have entered the follow-up phase of the trial.  Mean reduction in total IgG levels from baseline to end of treatment was 65%.  As evaluated at the end of treatment, 4/7 patients (57%) improved by ≥ 2 points on the Clinical Activity Score (CAS).  Of six patients with baseline diplopia, 4/6 patients (67%) demonstrated improvement in diplopia.  3/7 patients (43%) were proptosis responders.  The safety and tolerability profile observed was consistent with the prior Phase 1 trial of IMVT-1401 in 99 healthy volunteers.  All AEs were mild or moderate and there were no headaches reported.c


HL161 is an anti-FcRn complete human antibody developed by HanAll Biopharma. Unlike intravenous infusion (IV infusion) or subcutaneous infusion (SC infusion), HL161 is being developed as a pre-filled syringe product that can be subcutaneously injected by patients. Through a license agreement in 2017, Immunovant holds the business rights for the North America, Europe, South and Central America, Middle East, and North Africa regions; Harbour BioMed holds the business rights for the Greater China region; and HanAll Biopharma holds the business rights for Asian regions except China, Oceania, and Eastern Europe. The three companies are producing synergy in the development of indications for at least five severe autoimmune diseases based on a global alliance.