NTI ASD patients still being treated after 90 weeks
Our biotech Investment, Neurotech International (ASX: NTI) just put out an update from its Autism Spectrum Disorder (ASD) clinical trials.
NTI is currently running a world-first Phase II/III clinical trial based on its cannabinoid drug therapy, NTI164.
Results from the Phase II/III clinical trial are due later in Q1/early Q2-2024.
Leading up to the extended clinical trial, NTI had run a Phase I/II clinical trial - the primary objective for that was to show the safety and efficacy of NTI’s drug following ~30 days of use.
Today, NTI confirmed that 11 of the patients who had participated in the Phase I/II clinical trial had just passed the 90 week mark of using NTI164.
A major milestone considering the intended goal for the initial trials was to just establish safety/efficacy.
Our key takeaways from today’s announcement were as follows:
- 11 of the patients enrolled in NTI’s initial Phase I/II clinical trial have now passed the 90-week mark using NTI’s drug.
The fact that patients have continued using the drug beyond the intended Phase I/II clinical trial period tells us that the drug is having a positive impact on their lives.
Some of the feedback from the patient’s parents seems to back that up as well:
- Safety and tolerability profile for all patients is looking good even at the 90 week mark.
NTI also confirmed that all of the patients that are continuing to use NTI164 are showing stable blood chemistries as well as normal liver and kidney function.
NTI also mentioned that “caregiver and clinician reports remain positive with symptomatic improvement maintained at 90 weeks” another datapoint that backs up the impact NTI164 is having on the patients using it.
- NTI’s study is now the longest ever examining the safety of a cannabinoid drug treatment for ASD.
Hitting the 90 week mark makes it the longest ever safety study for a cannabinoid-based drug in treating ASD.
The significance of this is that NTI can use all of the longer term data when it builds a case to present to regulators.
At the end of the day regulators like the FDA look at data in a wholistic matter - the more positive datapoints the stronger a case is for a drug to be approved for a specific use.
Things like long term safety data can be a major positive when a biotech is looking to go through all of the regulatory approval hurdles.
Why we think the Phase I/II clinical trial is a major catalyst for NTI -
A few weeks back we covered why we think the Phase I/II clinical ASD trials could be a big catalyst for NTI.
Check out our detailed note here - NTI autism clinical trial results in next 8 weeks - can it save billions of dollars in NDIS funding needs?
What’s next for NTI?
Catalyst 🔄 - Phase I/II Rett Syndrome clinical trial (results in Q1 CY2024)
A trial on another child neuropsychiatric disorder called Rett Syndrome - Neuren Pharmaceuticals re-rated ~1300% on commercialisation of its treatment for this disorder.
We think NTI could be safer than Neuren’s treatment and if it works better or similar, hopefully, re-rate accordingly.
Catalyst 🔄 - Phase II/III trial for Autism Spectrum Disorder (results in Q1/Early Q2 2024)
After promising Phase I/II trial results, we see this trial as potentially opening more doors when it comes to commercialisation.
