- The MG-ADL (myasthenia gravis activities of daily living) index, which assesses the effect of improvement in symptoms as experienced by a patient, increased by an average of 3.8 points, which is a statistically significant improvement in comparison to the placebo group (p=0.029).
- The MGC (myasthenia gravis composite) index, which combines the value measured by a physician and the effect of improvement in symptoms as experienced by a patient, increased by an average of 8 points, which is a statistically significant improvement in comparison to the placebo group (p=0.006).
- For HL161, there were no cases of suspension of administration due to a serious adverse reaction matching the results of the Phase 1 clinical trial or an adverse reaction. Also, the result indicated safety and excellent tolerability for the drug.
- Phase 3 clinical trials for the new drug permit are expected to begin in the first half of next year.
On the 25th (local time), Immunovant, HanAll Biopharma’s global partner for HL161 (INN: Batoclimab), announced the Phase 2 clinical trial results for HL161 for myasthenia gravis through a press release and a conference call.
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.
Immunovant has announced a plan to increase the three disease indications (myasthenia gravis, thyroid eye disease, and warm antibody autoimmune hemolytic anemia) to six, which leads to expectations for the application of HL161 to a number of autoimmune diseases.
The MG-ADL (Myasthenia Gravis Activities of Daily Living) index is an endpoint for myasthenia gravis recognized by the FDA. This is an eight-question survey to ask patients about MG symptoms, such as on the eye, respiratory system, and limbs. MGC (Myasthenia Gravis Composite) is an index combining the physician’s opinion and the patient’s self-assessment. This is an endpoint to measure the frequency and severity of abnormal symptoms in relation to ten items.