--Collaborative Medicinal Development LLC (CMD), announces that it was awarded a AU$1 million grant from FightMND to support a Phase 2 study of CuATSM for treatment ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease, or Motor Neuron Disease (MND).
The Background
In 2016, FightMND helped to support the phase 1 clinical trial of CuATSM where it was given to MND patients as a therapeutic for the first time. The primary objective, as per any phase 1 trial, was to assess safety and tolerability of the drug and, if possible, identify a dose that could be taken to the next round of testing. By assessing the drug at a number of different doses the trial successfully identified a recommended dose for phase 2 testing. Although a Phase 1 study is not designed to prove efficacy, signals of disease modification were demonstrated. Accrual to the Phase 1 study is now completed.
The Plan
The next step in development is to perform a randomized, double blind, placebo controlled study. "With FightMND's generous second grant, the Phase 2 study will start later in 2019" said Dr. Craig Rosenfeld, the CEO of CMD. Phase 2 study details will be posted on https://clinicaltrials.gov/ in the next few months.
CMD's goal is to advance a disease modifying therapy for ALS and to have CuATSM approved by the FDA.
FightMND
"FightMND is dedicated to finding an effective treatment or cure for MND, also referred to as ALS or Lou Gehrig's disease," said Rebecca Sheean, Ph.D., Research Manager of FightMND. "FightMND's support for CMD to perform a Phase 2 study of CuATSM is consistent with our goals. We are excited that our support for CMD has allowed CuATSM to advance towards this next phase of clinical testing and hopefully towards a disease modifying therapeutic for patients with ALS."
About CuATSM
CuATSM is a once daily oral medication. The effectiveness of CuATSM was replicated in four mouse models of ALS. Further, the therapeutic potential of CuATSM in ALS was corroborated at three independent sites.
About Amyotrophic Lateral Sclerosis (ALS)
ALS is a progressive and fatal neurodegenerative disease characterized by muscle weakness resulting from degeneration of motor neurons. Patients usually die of respiratory failure within 2 to 3 years of symptoms onset. There is an urgent unmet medical need for disease-modifying therapies in ALS.
