Merz Therapeutics Advances Migraine Research With Enrollment of First Patients in Two Global Phase III Clinical Trials for XEOMIN® (incobotulinumtoxinA)
Merz Therapeutics GmbH, a neurology-focused specialty pharmaceutical company, announced a significant advancement in its clinical research program with the enrollment of the first patients in two pivotal Phase III clinical trials: MINT-E (NCT07018700) and MINT-C (NCT07018713). These studies are designed to rigorously assess the efficacy and safety of XEOMIN® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults.
The milestone marks a new chapter in Merz Therapeutics’ efforts to address unmet needs in migraine management. With more than 1.1 billion people worldwide estimated to suffer from migraines, the condition represents not only a major medical challenge but also a profound social and economic burden.
“Despite the availability of multiple treatment options, the need remains for additional preventive therapies,” said Stefan König, Chief Executive Officer of Merz Therapeutics. “The initiation of the MINT trials is an important step toward delivering a new neurotoxin-based approach that could provide meaningful relief for patients who continue to struggle with recurrent and debilitating migraines.”
Details of the MINT Program
The MINT (Migraine Neurotoxin Trials) program consists of two large-scale, randomized, placebo-controlled Phase III studies that together will enroll approximately 1,770 adult patients across 120 clinical sites in North America and Europe.
- MINT-E (Episodic Migraine)
- Target enrollment: ~990 participants
- Population: Adults with episodic migraine, defined as fewer than 15 headache days per month, of which 6 to 14 are migraine days.
- MINT-C (Chronic Migraine)
- Target enrollment: ~780 participants
- Population: Adults with chronic migraine, defined as 15 or more headache days per month, of which at least 8 are migraine days, persisting for three or more months.
Both trials share a common primary endpoint: the change in monthly migraine days from baseline through Month 6.
Key secondary endpoints include:
- Reduction in monthly headache days
- Reduction in days requiring acute migraine medications
- Evaluation of migraine frequency during two-week intervals at the end of each injection cycle
Patient enrollment has already begun at multiple North American sites, while recruitment in Europe is expected to commence shortly. The studies will be conducted in strict alignment with U.S. Food and Drug Administration (FDA) guidelines and corresponding European regulatory frameworks.
“These trials were carefully designed with patients’ experiences in mind,” explained Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “By capturing real-world patterns of migraine attacks and incorporating endpoints that reflect both clinical outcomes and quality-of-life impacts, we hope to generate evidence that resonates with healthcare providers and patients alike.”
Migraine: A Global Burden
Defining the Condition
Migraines are a type of neurological disorder characterized by recurrent attacks of moderate to severe headache pain. Merz Symptoms often include nausea, vomiting, and sensitivity to light and sound, and in many cases, attacks are preceded by an aura, which may involve temporary visual disturbances or other sensory changes.
The duration of a migraine attack can range from four hours to three days, and for many sufferers, the unpredictability of onset contributes significantly to psychological stress and functional impairment.
Episodic vs. Chronic Migraine
- Episodic migraine: Occurs fewer than 15 days per month, but still imposes a serious burden on work productivity and daily living.
- Chronic migraine: Defined as occurring 15 or more days per month for at least three months. Patients in this category typically experience greater severity, higher disability levels, and increased healthcare utilization compared to those with episodic migraine.
Broader Impact
The burden of migraine extends far beyond physical pain. The disorder is associated with:
- Psychiatric comorbidities such as depression and anxiety
- Cognitive impairment during and between attacks
- Social isolation due to unpredictability and stigma
- Economic consequences, including missed workdays and increased healthcare expenditures
According to the Global Burden of Disease Study, migraine is among the top causes of years lived with disability (YLDs) worldwide, highlighting its significance as a public health issue.
XEOMIN®: A Potential New Preventive Option
What is XEOMIN?
XEOMIN® (incobotulinumtoxinA) is a highly purified botulinum toxin type A product currently approved in the United States and other markets for multiple Merz neurological and therapeutic indications.
Its approved uses include:
- Treatment of chronic sialorrhea (drooling) in adults and children aged 2 years or older
- Treatment of upper limb spasticity in both adults and pediatric patients (2–17 years, excluding cerebral palsy-related spasticity)
- Treatment of cervical dystonia (CD) in adults
- Treatment of blepharospasm (abnormal eyelid spasms) in adults
XEOMIN works by Merz temporarily blocking the release of acetylcholine, a neurotransmitter responsible for activating muscle contractions and glandular secretions. Its potential benefit in migraine prevention lies in its ability to modulate peripheral and central pain pathways by reducing excessive neural activity at neuromuscular junctions.
Why Migraine?
Botulinum toxin is already used in the U.S. for chronic migraine prevention (onabotulinumtoxinA, marketed as BOTOX®). However, Merz aims to introduce XEOMIN as a differentiated option, potentially offering:
- A cleaner formulation, free from complexing proteins, which may reduce the risk of neutralizing antibody formation
- A well-established safety profile from its use across multiple therapeutic areas
- An opportunity to provide choice and flexibility for both physicians and patients
If successful, the MINT trials could position XEOMIN as a competitive and complementary treatment in the migraine prevention market, which continues to evolve with new therapies including CGRP monoclonal antibodies and oral CGRP antagonists (gepants).
Designing Trials With Patients in Mind
Merz emphasizes that the MINT studies were built around real-world patient experiences. The trials incorporate endpoints beyond traditional headache frequency, capturing aspects such as:
- The need for acute rescue medications
- Patterns of attacks over time
- Quality-of-life measures that assess the ability to work, study, and engage in daily activities
The company has also made efforts to ensure diverse enrollment across North American and European populations, reflecting variations in migraine prevalence, healthcare systems, and treatment access.
Dr. Albrecht noted: “We deliberately included both episodic and chronic migraine populations in order to better understand XEOMIN’s utility across the full spectrum of disease severity.”
Safety Information for Patients
As part of its commitment to transparency, Merz highlighted important safety information regarding XEOMIN.
Key safety considerations include:
- Serious risks: Difficulty swallowing, speaking, or breathing due to toxin spread, which in rare cases may be life-threatening.
- Risk groups: Patients with pre-existing swallowing or breathing problems, neuromuscular disorders (such as ALS, myasthenia gravis, or Lambert-Eaton syndrome), or those with prior botulinum toxin exposure may face heightened risks.
- Potential systemic spread: Symptoms resembling botulism—such as generalized muscle weakness, double vision, drooping eyelids, or loss of bladder control—may occur hours to weeks after injection.
- Interactions with other medications: Antibiotics, muscle relaxants, allergy medications, or sleep aids may increase the risk of adverse reactions.
The most common side effects vary by indication but include:
- Dry mouth, diarrhea, and high blood pressure in chronic sialorrhea
- Nasal congestion, bronchitis, and seizure risk in upper limb spasticity
- Neck pain, swallowing difficulty, and muscle weakness in cervical dystonia
- Drooping eyelids and vision disturbances in blepharospasm
Merz advises patients to consult their healthcare providers before beginning XEOMIN therapy and to report any unusual or severe side effects immediately.
The Significance of the MINT Trials
The enrollment of patients in the MINT-E and MINT-C trials is more than a procedural milestone—it is an indication of Merz’s broader strategy to expand the therapeutic applications of XEOMIN while addressing unmet needs in neurology.
If the trials demonstrate positive outcomes, XEOMIN could become:
- An alternative neurotoxin-based preventive treatment for migraine
- A competitor to BOTOX® in the chronic migraine space
- A potential first-line or adjunctive preventive therapy alongside CGRP-targeting treatments
This development also reflects Merz’s ambition to strengthen its global neurology franchise, which currently spans spasticity, movement disorders, and sialorrhea.
As patient enrollment continues, the industry will watch closely for early data readouts and regulatory interactions. While results are not expected for some time, the initiation of these studies reinforces a growing recognition: migraine prevention remains an area of intense innovation and competition.
By pursuing migraine as a new frontier for XEOMIN, Merz Therapeutics is signaling its commitment to neurology and to the millions of people worldwide who endure the challenges of this disabling condition.
“Ultimately, our goal is to expand the treatment landscape so that every patient has access to the therapy that works best for them,” said König. “With MINT, we are one step closer to making that vision a reality.”
Migraines remain one of the most prevalent and disabling neurological disorders, affecting over a billion people worldwide. While new preventive treatments have entered the market in recent years, significant gaps persist in accessibility, efficacy, and tolerability.
The MINT-E and MINT-C trials represent Merz Therapeutics’ bold step toward addressing those gaps. By investigating the role of XEOMIN® (incobotulinumtoxinA) in migraine prevention, Merz is not only expanding the scientific understanding of neurotoxins but also striving to give patients and clinicians more options in the fight against migraine.
With rigorous trial designs, patient-centered endpoints, and a strong safety framework, the MINT program holds the potential to reshape the preventive migraine treatment paradigm—offering hope to millions who continue to live under the shadow of recurring, debilitating headaches.
