- 3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale was statistically significant vs. placebo (p = 0.029)
- 8.0-point mean improvement on Myasthenia Gravis Composite (MGC) scale was highly statistically significant vs. placebo (p = 0.006)
- Mean reductions in total IgG from baseline for the 340 mg and 680 mg cohorts were 59% and 76%, respectively
- IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs) and no withdrawals due to adverse events (AEs)
- Registration-enabling Phase 3 MG trial is expected to initiate in the first half of 2021
NEW YORK, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced positive topline results from ASCEND MG, a Phase 2a study of IMVT-1401 in patients with myasthenia gravis (MG).
The multi-center, randomized, placebo-controlled trial was designed to evaluate the safety, tolerability, pharmacodynamics, and efficacy of IMVT-1401 in patients with moderate-to-severe generalized MG. Results from the six-week treatment period included three arms: 340 mg IMVT-1401 weekly (N=5), 680 mg IMVT-1401 weekly (N=5), and placebo (N=5).
As evaluated in a pre-specified, pooled analysis of 15 patients who completed Day 42, IMVT-1401-treated patients (N=10) showed a mean 3.8-point improvement on the MG-ADL scale vs. a mean decline of +0.6 for placebo, a result that was statistically significant (p = 0.029). IMVT-1401-treated patients also showed a highly statistically significant improvement on the MGC scale, with an average improvement of 8.0 points vs. a mean decline of +1.4 for placebo (p = 0.006).
MG-ADL responder rates, defined as the percentage of patients showing a > 2-point improvement, were 60% for IMVT-1401-treated patients vs. 20% for placebo. MG-ADL deep responder rates, defined in the study as the percentage of patients showing a > 6-point improvement, were 40% for IMVT-1401-treated patients vs. 0% for placebo. MGC deep responder rates, defined in the study as the percentage of patients showing a > 10-point improvement, were 40% for IMVT-1401-treated patients vs. 0% for placebo.
Consistent with previously reported Phase 1 results, IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs), no withdrawals due to adverse events (AEs), and no imbalance in headaches. Mean reductions in total serum IgG from baseline for the 340 mg and 680 mg cohorts were 59% and 76%, respectively.
"We are absolutely thrilled with the results of this trial," said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. "The clinical benefits we observed in this trial provide strong support that IMVT-1401 might ultimately become a best-in-class anti-FcRn agent for MG patients. Importantly, IMVT-1401 was delivered by subcutaneous injection, opening the future possibility of at-home, self-administered treatment rather than infusion center-based treatment. We look forward to engaging with the FDA later this year on the design of our Phase 3 registrational program in MG."
After taking into consideration the impact of COVID-19 and the validation of the anti-FcRn mechanism in MG as discussed in its June 29th press release, Immunovant elected to unblind the study after 15 of an anticipated 21 patients had completed the six-week treatment course.
"Although this small Phase 2a study was designed principally to evaluate safety and tolerability, as well as changes in IgG antibodylevels, it is extremely encouraging to see such promising early results on a range of MG outcome measures," said Michael Benatar, M.D., M.S., Ph.D., Chief of the Neuromuscular Division at the University of Miami. "Results of this study will provide critical insights for the design and implementation of a pivotal phase 3 study," he added.
Immunovant will host a conference call on Tuesday, August 25 at 8:30am EDT. Following prepared remarks, the call will include a live question-and-answer session for the investment community. To access the webcast, please visit Immunovant's website at www.immunovant.com. Participants may also dial in using the numbers provided below:
Toll Free: 1-877-407-9039