AdventHealth recruiting for study of IDP-023 in progressive MS
Phase 1b clinical trial is now open to adults in Orlando; more sites expected
The AdventHealth Neuroscience Institute is recruiting patients for a Phase 1b clinical trial testing IDP-023, an off-the-shelf cell-based treatment that Indapta Therapeutics is developing for primary or nonactive secondary progressive multiple sclerosis (MS).
The company delayed the study’s expected launch in the second half of last year, but recruitment into the clinical trial (NCT06677710) is now open to adults with a diagnosis of primary or nonactive secondary progressive MS at AdventHealth in Orlando. Four additional sites are expected to open in the U.S.
The trial, dubbed IDP023-2-101, is recruiting an estimated 34 patients, ages 18-65, who’ve been treated with Ocrevus (ocrelizumab) in the past six months. Along with Ocrevus, all eligible patients will receive IDP-023 at one of three doses.
“We’re excited to be the only site in Florida and one of the first in the country to offer this groundbreaking clinical trial,” Anita Fletcher, MD, a neurologist who’s leading the trial in Orlando, said in a AdventHealth press release. “Studies like these are a key part of our commitment to finding new and better treatments that could improve the quality of life for patients suffering from MS.”
In MS, the immune system mistakenly launches an inflammatory attack that damages nerve cells in the central nervous system, which is made up of the brain and spinal cord. Immune B-cells are thought to cause most of the damage that leads to neurodegeneration.
IDP-023 aims to halt MS progression
In both primary and secondary progressive MS, symptoms gradually worsen over time. Unlike primary progressive MS (PPMS), which progresses steadily from its onset, secondary progressive MS (SPMS) usually develops from relapsing-remitting MS, where patients recover after periods when symptoms worsen or new ones appear.
While “there have been significant advancements in treating relapsing [MS],” Fletcher said, “most of the standard-of-care disease-modifying therapies available to us are not fully effective in slowing progression for PPMS or nonactive SPMS.” Ocrevus remains the only approved treatment in the U.S. for PPMS.
The available disease-modifying therapies “reduce inflammation in the central nervous system and, with the progressive forms of [MS], the primary challenge is nerve degeneration rather than inflammation,” said Fletcher, adding, the focus with IDP-023 “is to realign the patient’s immune system to slow or halt progression of the MS.”
Given as an infusion into the bloodstream, IDP-023 contains donor-derived natural killer (NK) cells, a type of immune cell that helps keep inflammation in check. The NK cells in IDP-023, called g-NK cells, develop in response to cytomegalovirus, a common virus.
These unique g-NK cells release more immune-signaling proteins called cytokines than regular NK cells. They also work better at eliminating cells that have been flagged by specific antibodies, which are produced by B-cells. The g-NK cells are also able to target and kill other immune cells implicated in the inflammatory attacks that drive MS. Altogether, this could help restore the immune balance, easing MS symptoms.
The IDP023-2-101 clinical trial has two parts. The first part will test different doses of IDP-023 in combination with Ocrevus and interleukin-2 (IL-2), a cytokine that helps NK cells grow and survive, while boosting their benefits toward a balanced immune system. The goal is to assess the therapy’s safety and find the best dose for the next part.
In the second part, researchers will watch for changes in autoreactive immune cells over two years after patients receive IDP-023 in combination with IL-2 and Ocrevus. The patients will receive IDP-023 for up to five days and may stay in the hospital for at least four. They’ll then return for checkups within a week or a month, then every three months for two years.
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