FDA lifts partial clinical hold on Vigil Neuroscience's TREM2 antibody, removing dosing cap

30 Mar 2023
endpts.com
Phase 1IPO
When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level. More than a year later, the FDA has lifted the hold. Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord. “Although we believe that 20 mg/kg is a clinically relevant dose in ALSP, we are very pleased that the hold has been lifted as we believe it’s important to maintain optionality to develop treatments that support patients suffering from both rare and common neurodegenerative indications,” president and CEO Ivana Magovčević-Liebisch said in a statement. The biotech has tested the drug among both healthy volunteers and patients with ALSP in trials conducted in the US and Australia, where it’s been exploring doses above the 20 mg/kg threshold, up to 60 mg/kg. Data from the ongoing Phase I trial helped convince the FDA, according to the company. Stifel analyst Paul Matteis noted that ultimately, the higher doses may not be necessary, but it’s hard to tell until Vigil tests it. “That said, for monoclonal antibodies in the brain, more (up to a certain point) is often better, and given the safety so far, it seems reasonable that Vigil would continue to dose escalate further as trials in ALSP/Alzheimer’s progress,” he wrote. Vigil licensed VGL101 alongside a small molecule TREM2 agonistTREM2 agonist from Amgen after the big drugmaker decided to exit neuro. TREM2, believed to be a microglia sensor involved in transmitting signals to cells, is a target also being chased by companies like Alector .
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