Frequently Asked Questions
What is TW001?
TW001 is a drug that is currently being developed by Treeway for the treatment of ALS. The active ingredient in TW001 is edaravone.
What is Treeway’s role in developing this medicine?
Treeway is the pharmaceutical company that develops TW001 for the treatment of ALS.
When will TW001 be on the market?
TW001 can only be allowed on the market after it has received market authorization by the EMA (in Europe) or FDA (US) who will grant access based upon the efficacy and safety results of our clinical studies.
What is the difference between oral and intravenous administration?
Intravenous administration means the drug is given by injection into a vein. When a drug is taken orally, it is taken through the mouth.
What is a clinical study?
A clinical study involves research, using human volunteers/patients (also called
participants), that is intended to add to medical knowledge. There are two main types
of clinical studies: clinical trials (also called interventional studies) and observational
What are the first results of the (small) clinical studies?
The first small clinical studies showed that TW001 was safe and well tolerated and reached the concentrations in the blood that are considered needed to achieve a therapeutic effect.
Can I participate in the upcoming large efficacy TW001 clinical trial, how do I sign up and what are the requirements?
The requirements to participate are still under discussion and will be announced when the clinical trial has been approved by the medical ethical committee. You can also register your interest in a clinical trial via www.tricals.org.
What is being studied in the TW001 clinical trial?
The effect of TW001 on disease progression of ALS will be studied.
When does the clinical study start?
The clinical study will start after approval by the competent medical ethical committees in the participating centres.
I live outside Europe. Can I participate in the large efficacy TW001 trial?
The large efficacy TW001 study is a European study so only people living in the proximity of one of the participating sites can participate.
TW001 PHASE 3
What does it mean if a drug is in phase 3 of development?
During the phase 1 trials the safety, tolerability and concentrations in the blood of TW001 were tested. In the phase 3 clinical trial Treeway will test whether TW001 is effective in slowing the disease progression.
What is the difference between Radicut® and TW001?
Both Radicut® and TW001 contain the same active ingredient, edaravone. Radicut® is approved in Japan for the indication ALS and in the USA it is approved under the name Radicava®. TW001 is currently in clinical stage. Radicut® is given by injection into the vein (intravenously) and with drug holidays. TW001 is a formulation of edaravone that is envisaged to be taken orally without drug holidays.
What is MCI-186?
MCI-186 is the code name given by Mitsubishi Tanabe for the development of Radicut in the indication ALS
What is the difference between PMA (Progressive Muscular Atrophy) and ALS (Amyotrophic Lateral Sclerosis)?
In PMA only the lower motor neurons are affected. In ALS both the upper and the lower motor neurons are affected. Common ALS encompasses both upper and lower motor neurons and the patients with this are affected from their head to their toes. PMA involves only the lower, which includes extremities, torso and lungs.
What is TRICALS?
Treeway is the first biotech company that cooperates with TRICALS, the Treatment Research Institute for the cure of ALS. TRICALS is an international, online platform for people with ALS. Together with ALS centres and the pharmaceutical industry, people with ALS will stand together to find a better treatment for this devastating disease. For more information: www.tricals.org
(this page will soon be available in Dutch).