I am writing to see if anyone else is aware of this new very promising clinical trial for ALS. I believe this could be the drug we have been waiting for all these years. Please contact your clinic or doctor to see if they are recruiting now for this trial. I would love to be in this trial but am excluded because of 7 year symptom onset.
What can we do as ALS patients to bring this drug to market is quickly as possible. One thing ee can do is volunteer for the trial and another is to contact the CEO of neutraltus.
Here are some of the points you might include in your e-mail. The CEO, e-mail address is at the end of this post.
1) Pursuing a drug for ALS, even though the market is much smaller than for many ailments.
2) For the atypical speed with which they completed phase I and progressed to phase II for NP001.
3) For expanding their inclusion criteria to 36 months post-onset (was only 24 months).
4) Please have their Data Safety Monitoring Board (DSMB) frequently and closely monitor the results to detect the apparent effectiveness of NP001 and consider changing to open label as quickly as possible, as it may be unethical to continue placebo for 1/3, while many seem to be improving on the drug (and not just experiencing slowed disease progression). The ALSFRS-R scale is crude and may not enable indications of subtle, but real, improvements which do not result in a whole point increase in the scale, but will over a longer period result in possible gains or slowed/no loss.
5) Please consider extended open label use for the volunteers of the study at a minimum, and consider compassionate use to anyone disqualified from the likely future phase III.
6) Express that the ALS community is very excited about about the few reports of effectiveness through either forums or other communication. It may help Neuraltus Pharmaceuticals secure any necessary additional investment funding, if necessary and essential to continue their momentum towards phase III and FDA approval.
Direct Email for Andrew Gengos firstname.lastname@example.org
. Thanks for being so patient with this new first long post.