Lundbeck initiates a phase III trial with amlenetug for the treatment of Multiple System Atrophy

MASCOT, a global phase III randomized, double-blind, placebo-controlled trial, will assess the efficacy and safety of amlenetug in the treatment of Multiple System Atrophy (MSA)

H. Lundbeck A/S (Lundbeck) today announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial.

The trial builds on the encouraging results of the AMULET phase II trial showing consistent trend towards amlenetug slowing clinical progression in MSA patients despite the primary endpoint not meeting statistical significance and follows discussions with health authorities.

“This is an important step forward in our commitment to addressing the unmet needs of patients with Multiple System Atrophy. We are hopeful about the potential of amlenetug to slow the clinical progression of this devastating disease and look forward to advancing its development through the MASCOT trial,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck.

Amlenetug is an investigational human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein, thereby believed to prevent uptake and inhibit seeding of aggregation.

Amlenetug may offer a potential treatment option that slows clinical progression for people with MSA.

About the MASCOT trial (NCT06706622)
MASCOT is a phase III, interventional, randomized, double-blind, parallel-group, placebo-controlled, optional open-label extension trial that will be conducted in North America, Europe, and Asia.

The trial comprises 2 parts: A double-blind period where participants are randomized to receive either high or low doses of amlenetug, or placebo for 72 weeks, followed by an open-label extension period where all participants enrolled in the trial are offered treatment with amlenetug

The aim of the trial is to evaluate the efficacy, safety, and tolerability of amlenetug in patients with MSA. Amlenetug will be delivered as an intravenous infusion every four weeks.

About amlenetug
Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein and thereby is believed to prevent uptake and inhibit seeding of aggregation. Amlenetug has an active Fc region, which may increase immune-mediated clearance of α-syn/mAb complexes through microglia mediated uptake. Amlenetug is being developed by Lundbeck under a joint research and licensing agreement between Lundbeck and Genmab A/S. 

About Multiple System Atrophy
MSA is a rapidly progressing rare condition that causes damage to nerve cells in the brain. MSA is seriously debilitating and places a high disease burden on patients. Symptoms of MSA usually start between 55 and 60 years of age, and patients typically live for 6 to 9 years after symptom onset¹.

In a person with MSA, an abnormal build-up of the protein alpha-synuclein is thought to be responsible for damaging the areas of the brain that control balance, movement, and the body's normal functions¹. The symptoms of MSA are wide-ranging and include muscle control problems, similar to those of Parkinson's disease¹. Many different functions of the body can be affected, and symptoms including urinary incontinence, frequent falling, and unintelligible speech occur within 3 years of disease onset and are accompanied by reduced capacity to live independently. Death is often due to respiratory problems. Although there are many different possible symptoms of MSA, not everyone who is affected will experience all of them. There is currently no cure for MSA and no available treatment to slow its progression¹.
 

References:

1 – NHS: Multiple system atrophy - NHS (www.nhs.uk)

H. Lundbeck A/S (Lundbeck)

Contacts

About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Denmark

+45 3630 1311

info@lundbeck.com