EU agency say no trials of mesdopetam in children are needed

28 January 2025

A large bell marked with the word 'update' in all capital letters is flanked by two smaller ringing bells.

The European Medicines Agency (EMA), which evaluates the safety and efficacy of new drugs in the European Union, has waived a requirement that would have had Irlab Therapeutics conducting clinical trials testing mesdopetam — its therapy candidate for levodopa-induced dyskinesia, or uncontrolled, involuntary movements common in Parkinson’s disease patients — in children.

The decision follows the recommendation of the EMA’s Pediatric Committee and frees the company from the obligation of submitting pediatric investigation plans for the new drug. Such testing would otherwise be compulsory before an EU marketing authorization application could be submitted.

The waiver recommendation may be given to pharmaceutical companies in cases in which developing a certain drug for children is not appropriate or feasible.

“We are pleased that EMA has confirmed that pediatric studies evaluating mesdopetam are not needed to support a market authorization application for Parkinson’s disease,” Kristina Torfgård, PhD, Irlab’s CEO, said in a company press release. According to Torfgård, Irlab already had received a similar decision from the U.S. Food and Drug Administration (FDA).

Recommended Reading

A close-up image of a handshake between two people, one wearing a watch.

IRLAB ramps up for mesdopetam Phase 3 program in Parkinson’s

Developer planning Phase 3 trial of mesdopetam in adults

Parkinson’s is caused by the progressive loss of dopaminergic neurons, which are the nerve cells responsible for producing the signaling molecule dopamine. Reduced dopamine signaling ultimately gives rise to most of the disease’s symptoms.

The mainstay treatment for Parkinson’s is levodopa, a medication that provides a molecule that cells can use to produce dopamine. Although levodopa is effective at easing Parkinson’s motor symptoms, its long-term use frequently leads to dyskinesia, or uncontrolled movements, and so-called off periods, or times when symptoms are not well controlled between doses.

Mesdopetam, formerly IRL790, is an Irlab therapy that’s designed to block the activity of a dopamine receptor called D3, which has been linked with levodopa-induced dyskinesia.

In a Phase 2b clinical trial (NCT04435431) in adults, the treatment’s higher dose — 7.5 mg, given twice daily — was shown to ease levodopa-induced dyskinesia relative to a placebo. It increased patients’ good on time and reduced off times and dyskinesia severity compared with the placebo. Good on time is defined as periods in which symptoms are well-controlled without dyskinesia, while off times are periods when symptoms are not well-controlled.

Since we have previously received a corresponding decision from the … [FDA], the decision from EMA means we can now focus our development efforts entirely on activities in more relevant patient groups.

The company is now preparing a Phase 3 clinical trial to test mesdopetam’s efficacy in adults with Parkinson’s who have at least two daily hours of dyskinesia. Participants will receive the treatment at a dose of 7.5 mg, twice daily, or a placebo, for about three months.

Besides its anti-dyskinetic effects, mesdopetam also has been shown to reduce signs of psychosis in a mouse model of Parkinson’s. Psychosis is a common nonmotor symptom of the disease, characterized by hallucinations — seeing, hearing, or feeling things that do not exist — and/or delusions.

According to Torfgård, the EMA decision will allow Irlab to better advance the experimental therapy.

“Since we have previously received a corresponding decision from the … [FDA], the decision from EMA means we can now focus our development efforts entirely on activities in more relevant patient groups,” Torfgård said.

The post EU agency say no trials of mesdopetam in children are needed appeared first on Parkinson's News Today.

https://parkinsonsnewstoday.com/news/eu-agency-waives-pediatric-trials-mesdopetam-parkinsons/

Parkinsons News Today

Categories

0 Comments

Submit a Comment

Parkinsons, Odd behaviour and Medications

Parkinsons, Odd behaviour and Medications

Do you have a friend or loved one with Parkinsons ? You reckon that would be bad enough ? Is their behaviour a bit (or a lot or even dangerously) out of character? It may be the drugs they are taking and not their real self or the disease!Please read ALL of this post...

Introduction and Excuse me!

Introduction and Excuse me!

Pardon me, while I get this social media enterprise working. It has taken me 12 months to get this far with this editorial labyrinth. My former pre Parkinson’s self would have had this whipped up in a week or two, reality changes ability, however I won’t let it kill...

They Call me Shuffles

They Call me Shuffles

    A diagnosis with Parkinson's changes a lot of things: Motor function, non-motor functions, but maybe even more powerful is the changes in social interactions. I personally don't mind being called "Shuffles" now, I did at first (8 or so years ago I think), I...