IMVTW Immunovant Inc

Item 8.01Other Events.

On March 30, 2020, Immunovant issued a press release announcing initial results from its ASCEND GO-1 trial.

The ASCEND GO-1 trial is an open label single-arm Phase 2a clinical trial of IMVT-1401 in Canada in patients with moderate-to-severe active thyroid eye disease (“TED”, formerly referred to as Graves’ ophthalmopathy). Seven patients were dosed weekly with subcutaneous injections for six weeks. Patients received a 680 mg dose for the first two administrations of study followed by a 340 mg dose for the final four administrations. All patients have completed the six-week treatment phase of the trial, and have entered the 12-week follow-up phase.

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”).  Clinicians use CAS to measure disease activity in TED patients and is based on seven parameters, including spontaneous pain behind the eye, pain with eye movement, redness of the eyelids, redness of the conjunctiva, swelling of the eyelids, swelling of the caruncle and swelling of the conjunctiva. A score is calculated based on the number of parameters that are positive with scores of four or above considered to be cases of active disease. Of six patients with baseline diplopia, 4/6 patients (67%) demonstrated improvement in diplopia.  3/7 patients (43%) were proptosis responders, defined as the percentage of patients with a greater than or equal to 2 mm reduction in proptosis in study eye without deterioration in fellow eye.  The safety and tolerability profile observed was consistent with the prior Phase 1 trial of IMVT-1401 in 99 healthy volunteers.  All adverse events were mild or moderate and there were no headaches reported.

In addition, Immunovant has updated its anticipated clinical development timelines, in light of the significant uncertainty regarding the impact of the recent COVID-19 pandemic. Immunovant anticipates reporting top-line results from its ASCEND-MG trial, a Phase 2a clinical trial of IMVT-1401 in patients with myasthenia gravis, in the third quarter of calendar year 2020. Immunovant currently remains on track to report initial results from its Phase 2a trial of IMVT-1401 in patients with warm autoimmune hemolytic anemia by the end of calendar year 2020. Immunovant currently plans to report top-line results from its ASCEND GO-2 trial, a Phase 2b clinical trial of IMVT-1401 for TED in the United States, Canada and Europe, in the first half of calendar year 2021.

This Current Report on Form 8-K contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Immunovant makes regarding the timing, progress and reporting of results of its clinical programs are forward-looking. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others, the availability of data from clinical trials; the continued development of Immunovant’s product candidates; Immunovant’s scientific approach and general development progress; and the potential impact of the recent COVID-19 pandemic on Immunovant’s clinical development plans and timelines. These statements are also subject to a number of material risks and uncertainties that are described under the section titled “Risk Factors” in Immunovant’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on February 14, 2020, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.