Discover what’s in store for today’s presentations at The American Academy of Neurology’s annual meeting, which will include data for a variety of neurological treatments.
The American Academy of Neurology’s (AAN) annual meeting highlights cutting-edge treatments and breaking data in the neurology field. This year’s meeting is from April 2 to 7, and Tuesday’s presentations include fascinating data for a variety of neurological treatments, including drugs for myasthenia gravis, Parkinson’s disease and traumatic brain injury motor deficits.
One of today’s notable presentations will be from Netherlands-based immunology company argenx. The company announced interim results from its ADAPT+ open-label extension study of Vyvgart, a drug that treats generalized myasthenia gravis (gMG), a chronic autoimmune disease where autoantibodies disrupt signals between nerves and muscles.
Vyvgart is already approved in Japan. In December 2021, Vyvgart was also approved by the U.S. Food and Drug Administration to treat gMG. Both approvals were given because of positive results in argenx’s Phase III ADAPT clinical trial, which showed that patients treated with Vyvgart performed better in activities of daily living compared to patients treated with placebo.
Now, the Phase III ADAPT+ extension study is focused on the long-term safety, tolerability and efficacy of Vyvgart. In the trial, 139 patients received at least one dose of the drug, 106 of whom are anti-acetylcholine receptor (AChR) antibody positive.
The interim results of ADAPT+ continue to show “consistent and clinically meaningful improvement on both the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales,” according to the press release. Additionally, the safety and tolerability profiles of long-term treatment continue to be favorable.
Pharma Two B will also present data today focused on efficacy and safety data from its recently completed Phase III, randomized controlled trial of P2B001 in the management of early Parkinson’s disease. The privately held company develops therapeutics based on reformulation and combinations of drugs that have already been approved for neurological indications.
P2B001 is a combination of pramipexole, rasagiline and titrated pramipexole-ER. The data came from a randomized, double-blind, parallel study of 544 patients with Parkinson’s disease. The study compared the treatment of P2B001 compared with each of its individual component drugs. The results showed that P2B001 helped manage Parkinson’s disease symptoms better than any individual component drug, and P2B001 also had fewer side effects such as sleepiness and hallucinations.
“We are very pleased to share the positive data from our well-designed, rigorous, active-controlled Phase III study of P2B001 with the many neurologists who are attending AAN,” said Dr. Warren Olanow, professor at the departments of neurology and neuroscience at Mount Sinai and CEO of Clintrex Research Corporation.
A third notable presentation at AAN will come from the SanBio Group. SanBio will present a one-year analysis of its Phase II STEMTRA trial. The trial compared the company’s SB623 drug compared to sham surgery in patients who have chronic motor issues from a traumatic brain injury.
SB623 is an investigational, regenerative drug that uses bone marrow stem cells to help heal the damaged area of the brain.
In the Phase II study, 46 patients with brain injury motor issues were treated with the drug. Patients who were treated with SB623 experienced improved motor function and better capacity for daily living compared to patients who underwent surgery without SB623. SB623 was well tolerated—not a single patient withdrew from the study because of adverse events.
“These data reaffirm the potential for SB623 to regenerate the brain after injury, an implication that would not only profoundly change the lives of those living with chronic traumatic brain injuries, but help shape the future of regenerative neurologic research,” said Keita Mori, CEO at SanBio.
Based on these positive results, SanBio plans to initiate a Phase III trial in the U.S. The company has already submitted an application of the drug in Japan as well.
