September 26, 2026 – Aspartes Pharmaceuticals Announces Completion of Phase 1 Clinical Study Evaluating ASP-001 ODT Formulations.

Phase 3 Clinical Trial – ASP-001

We are currently developing a Phase 3 clinical trial evaluating ASP-001, our lead investigational therapy targeting the hemiplegic, dystonic and paroxysmal attack features of AHC.

[Enrollment in Part 2 & Part 3 starting Q4 2025]

Part 1: Planned delivery within 72 hours. This open-label, ascending dose finding study recruited acutely hypertensive women diagnosed with preeclampsia (PE) and gave birth within 72 hours. The DM199 dose gradually increased in 10 cohorts of three patients each, starting with an intravenous loading dose, followed by subcutaneous administration. DiaMedica reported positive results from Part 1a of its Phase 2 trial in July 2025, showcasing statistically significant reductions in blood pressure and dilation of intrauterine arteries. Additionally, DM199 did not cross the placental barrier, representing a significant potential safety advantage over other therapies in development.

Join the Clinical Trial to Study the Potential Benefits and Safety of a New Investigational Skeletal Muscle-Targeted Drug

The SYNAPSE-CMT Study is evaluating an investigational drug called ignaseclant in adults with Charcot-Marie-Tooth Disease in clinical sites located in the US, Europe and Canada.

The main purpose of this study is to learn how the study drug (ignaseclant) works and how safe the study drug is compared with placebo.

You may be able to take part in the SYNAPSE-CMT Trial if you are:

• 18 to 70 years of age
• Diagnosed with any genetically confirmed CMT 1 or CMT 2 subtype (note that this current study does not include patients with CMT 1X)
• Able to perform certain physical tests without the use of an ankle/foot brace (orthopedic inserts are allowed)
• Can attend 6 different in-clinic visits over a period of approximately 8 weeks (depending on scheduling)

You may be able to take part in the SYNAPSE-CMT Trial if you are:

• 18 to 70 years of age
• Diagnosed with any genetically confirmed CMT 1 or CMT 2 subtype (note that this current study does not include patients with CMT 1X)
• Able to perform certain physical tests without the use of an ankle/foot brace (orthopedic inserts are allowed)
• Can attend 6 different in-clinic visits over a period of approximately 8 weeks (depending on scheduling)

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you. It is important to note that future studies are being considered which will include expanded eligibility criteria specific to wider age ranges, use of an ankle/foot brace and additional subtypes.

There is no cost to participate in this study, and your reasonable travel costs will be reimbursed (flight, mileage, hotel, parking, meals).

For more information and to request involvement in this important Charcot-Marie-Tooth disease clinical trial, including cities/states of clinical trial sites and contact information for clinical coordinators, please visit clinicaltrials.gov or email NMD Pharma at: clinicaltrials@nmdpharma.com