Neurizon

We are pleased to announce that Neurizon Therapeutics initiated two pharmacokinetic (PK) studies to support the lifting of the clinical hold on our NUZ-001 IND application. Following ongoing engagement with the US FDA, we have submitted a formal request for advice detailing the two short-term PK studies required to generate additional animal exposure data. These studies are expected to address the FDA's data requirements and facilitate NUZ-001’s entry into the HEALEY ALS Platform Trial in H2 CY2025. Dr. Michael Thurn, MD & CEO of Neurizon Therapeutics, commented: "These studies reflect our proactive approach to addressing regulatory requirements and our unwavering commitment to advancing NUZ-001 as a potential treatment for MND/ALS and other neurodegenerative diseases." We look forward to sharing further updates as we progress toward bringing new hope to the MND/ALS community.

Today is Rare Disease Day – a day to raise awareness and advocate for the 300 million people worldwide living with a rare disease. Rare diseases are often complex, life-threatening, and overlooked, with patients facing limited treatment options and long diagnostic journeys. Fast facts about rare diseases: 🔹 72% of rare diseases are genetic, and many remain poorly understood. 🔹 Less than 5% of rare diseases have an approved treatment. 🔹 By 2030, the number of people affected by rare diseases is projected to exceed 500 million worldwide, highlighting the growing need for research, advocacy, and innovation. Amyotrophic Lateral Sclerosis (ALS) is one such rare disease – a progressive neurodegenerative disorder that impacts motor neurons, leading to loss of movement, speech, and eventually, life. Despite being rare, ALS has a devastating impact on patients, families, and caregivers, with an urgent need for innovation in treatment. On this Rare Disease Day, we stand with the rare disease community—patients, caregivers, researchers, and advocates—who work tirelessly to drive progress. Together, we can make a difference. #RareDiseaseDay #ALS #NeurodegenerativeDiseases #NeurizonTherapeutics #NUZ-001

This webinar was EPIC…

Still time to register for this exclusive Fierce Biotech event and learn about the latest breakthroughs in the ALS development with Neurizon and Ncardia.

We look forward to connecting with industry leaders and experts, and sharing the latest discoveries in the Neuroscience field at #BioNeuroscience conference next week. If you are attending, please reach out to Dr Michael Thurn and Sergio Duchini who will be representing Neurizon and discussing our latest progress in bringing NUZ-001 forward as a potential ALS/MND therapy to patients.

Walking Together for the ALS/MND Community 💙 This weekend, the Neurizon Therapeutics team proudly joined the MND Relay, walking side by side with patients, families, and advocates in the fight against motor neurone disease (MND/ALS). More than just a race, this event symbolizes endurance, resilience, and hope—values that drive our mission every day. As a company dedicated to advancing innovative treatments for ALS, we are committed not only behind the scenes but also in the community. We’ve volunteered, raised funds, and taken meaningful steps—both on the track and in our work—to bring new possibilities to patients who need them most. To everyone fighting this battle, we walk with you. And to the incredible MND Relay community and MND Victoria, thank you for inspiring us to push forward. #MND #ALS #HorizonOfHope #NeurizonTherapeutics #NeurodegenerativeDiseases #MakeItMatter #MNDRelay

A recent paper published in Nature Aging by Dr. Sabrina Paganoni and colleagues underscores the groundbreaking impact of the HEALEY ALS Platform Trial—a game-changing approach that accelerates discoveries and improves trial efficiency. This innovative model has the potential to revolutionize how we bring new treatments to patients with MND/ALS faster. At Neurizon Therapeutics, we are honored to be part of this pioneering effort as we prepare to evaluate NUZ-001 in this Trial. We believe this collaboration brings us another step closer to offering new hope to patients and their families. #ALSResearch #HEALEYALSTrial #NeurizonTherapeutics #HorizonOfHope #NeurodegenerativeDiseases

We look forward to joining Ncardia for an exclusive Fierce Biotech webinar about the latest in ALS research and drug development. Join us on Feb 20th at 1 PM ET and hear from the global leaders Dr. Michael Thurn and Jeroen De Groot who are driving the innovation in this field. Register at https://lnkd.in/eXQW9CVp #ALS #MND #NeurodegenerativeDiseases #innovation #NeurizonTherapeutics #Ncardia

Our CEO, Dr. Michael Thurn, recently spoke with Sean Boss about the significance of our newly granted U.S. patent for NUZ-001, reinforcing our position in the fight against neurodegenerative diseases, and in particular ALS/MND. This is a crucial step forward in our mission to bring transformative therapies to patients in need. Watch the full interview here: https://lnkd.in/gkc6BUsD

We are thrilled to announce that the United States Patent and Trademark Office (USPTO) has granted a patent covering the use of our lead drug candidate, NUZ-001, in neurodegenerative diseases, such as ALS/MND.   🔹 Extends IP protection in the U.S. until 2039 for NUZ-001 and related compounds targeting mTOR pathway-related diseases 🔹 Strengthens commercial potential and lays a solid foundation for future commercial discussions 🔹 Follows FDA Orphan Drug Designation (ODD) granted in May 2024, further reinforcing our IP estate and market position   This milestone propels our mission forward as we advance NUZ-001’s clinical development for ALS/MND and other neurodegenerative diseases.   Read the full press release at: https://lnkd.in/e3cSKCpi