First Patient Dosed in Phase 2 Trial of Oral Treatment to Ease Inflammation in Parkinson’s

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by Forest Ray PhD |

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FHL-301 trial being planned

Alkahest announced the dosing of a first patient in the Phase 2 trial for its Parkinson’s therapy AKST4290, an oral tablet aiming to ease the inflammation that can aggravate disease symptoms.

The efficacy and safety trial, called AKST4290-211 or TEAL (2019-001657-42), will measure AKST4290’s benefits in motor function and activities relevant to daily life in treated patients relative to those given a placebo, the company said in a press release.

AKST4290 is designed to block the protein eotaxin. Eotaxin accumulates in the bloodstream as we age, and is believed to cause increased inflammation.

Inflammation has long been observed in the brains of people with Parkinson’s, but only recently has the idea that it drives disease progression gained traction. Scientists now speculate that the alpha-synuclein clumps that accumulate inside neurons and are a hallmark of the disease, trigger the body’s inflammatory response.

An inflammatory response is a vital part of the immune system. But a prolonged response, as occurs in Parkinson’s, damages cells to promote progression.

Because the way in which AKST4290 modulates inflammation is not unique to Parkinson’s, it holds the potential to reduce inflammation associated with other age-related diseases. It is also being tested in a Phase 2 trial (2019-002821-31) for age-related macular degeneration.

The TEAL trial is the first testing AKST4290 as a potential Parkinson’s treatment.

The randomized and double-blind trial, taking place in Europe, will enroll about 120 patients on a stable dopamine-based medication like levodopa. All will be randomly assigned to either 400 mg of AKST4290 (200 mg twice a day) or a placebo for 12 weeks, then followed for another 30 days.

The primary endpoint, or the main result to be measured at the end of the trial, will be changes in motor function during off periods at week 12. These are periods characterized by the reappearance or worsening of symptoms due to a gradual decline or waning in a dopamine medication’s effectiveness. Motor function will be measured using the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 3.

Other endpoints include the compound’s safety and tolerability, as well as various clinical and functional features of an on-medication state.

Requests for more information about the trial, which may open test sites in the U.S., can be sent to Alkahest using this email address.

Few new treatment options for Parkinson’s have been approved since the introduction of dopamine promoters.

The trial is funded in part by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), which has also supported trials into several of Alkahest’s other Parkinson’s therapy candidates.

“Patients’ greatest unmet need is a therapy that prevents, slows or halts the progression of Parkinson’s disease. AKST4290 presents a novel approach toward that goal, and we’re keen to better understand its potential impact for the millions living with this disease and their loved ones,” Todd Sherer, chief executive officer of The Michael J. Fox Foundation, said in the release.