Annovis Bio Releases Promising Phase III Parkinson’s Data

[ChucklesUSA]

globenewswire.com/news-rele...

[LeharLover62]

This looks very promising. Some people are concerned that they didn’t meet the primary endpoint, but cognitive improvement is huge!

[park_bear]

Annovis missed their endpoints in the intent to treat population. They got good results in a post hoc subgroup of patients more than 3 years past diagnosis. This makes sense as a subgroup because early patients have mild symptoms making it hard to demonstrate much improvement. Also early patients only progress slowly so there will not be much progression in the placebo group either. (For these reasons I believe IKT is making a mistake by only taking unmedicated patients in their trial). I do find this result encouraging.

changes-in-mds-updrs-after-treatment-with-10mg-or-20mg-buntanetap

[WinnieThePoo in reply to park_bear]

The results suggest the possibility of efficacy. At least there is no dose inconsistency this time. But it's a contrived post hoc.The normal consensus backed by clinical trial is that PD progresses linearly during the first 5 years. It doesn’t hardly move inperceptably for 3 years and then leap off a Cliffe.

There were 168 patients in the over 3 years group. So about 300 on the excluded under 3 years group.

I think we need to see the unedited full trial top line data before we jump to conclusions. The fact that Annovis have delayed it's release for so long and opted for this post hoc analysis first is a concern

Inhibikase 201 trial is a phase 2,not a phase 3

[park_bear in reply to WinnieThePoo]

You are right to want to see the full data. Interestingly, the intent to treat group UPDRS part III response to 20 mg was the same as the subgroup. The difference was the overall group responded to placebo equally, whereas the subgroup did not respond to placebo at all. This strikes me as a better result than a non response to treatment.

ITT response

[MBAnderson]

They led us to believe there would be an open label extension if the results were good.

We'll see if they honor that.

Also, I suggested they measure results/improvement using digital wearables which have been show to be much more accurate then interviewing subjects.

[park_bear in reply to MBAnderson]

Maria said there would be an open label extension

[Ctime in reply to MBAnderson]

Q1 of 2025 is the open label trial

[Farooqji]

They have scheduled a webcast on July 2

zoom.us/webinar/register/WN...

[LeharLover62 in reply to Farooqji]

I signed up to listen…

we tried to get Buntanetap under right to try from them and I really think it should be made available now, as cog impairment is untouchable otherwise.

[redhawk1]

A little “Hope” is a beautiful thing!!!

[MBAnderson]

I. for one , am greatly relieved that they are committed to an open label extension. I was impressed by her remarks. Wee-ha. A solid reason for hope - even for us old timers.

[LeharLover62]

I watched the investor presentation just now, and she’s probably going to apply for FDA approval in October, even though she says that’s aggressive. They also will seek approval to open label it, which means trial participants can continue to get the drug.

[MBAnderson in reply to LeharLover62]

I thought she said we'd get it until it's approved.

[Ctime in reply to MBAnderson]

I heard that the open label would be starting Q1 2025, 6 moths prescription or supply with 6 month check ins. Continued until the drug was commercially available

[ChucklesUSA in reply to LeharLover62]

Maria said she welcomed the support of patient advocacy groups in making the application to the FDA. She indicated some had already reached out to ask how they can help. So, if you want access to the drug, ask your organization what they are doing to support to approval.