risvodetinib Phase 2 clinical trial fails. - Cure Parkinson's
risvodetinib Phase 2 clinical trial fails.
Thanks for this info. You are amazing! How do you find all these sources? Also please pray for me. I get DBS tomorrow . I have a very good surgeon. Am hoping this works ! CL had almost stopped working altogether. I’ve tried many alternatives and add-ons with no luck. After DBS if it does not work, the last alternative is Vyalev. My big fears are infection, bad constipation or becoming less functional than I am now (walker, terrible sciatica . Toe, hip and shoulder dystonia, constipation, frequent dizzy spells, can’t drive, shuffling )
Thanks. My prayers are with you deep from my heart. In my opinion you should prefer Vyalev over DBS. They are working on improved version and hopefully it will resolve the infection issues
I highly respect your opinion! But I feel I cannot physically or mentally wait any longer. My surgeon pointed out that vyalev will still be an option.
Wishing you good results with the DBS. 🤞
Poorly done trial. They should have allowed longer than 12 weeks in these very early stage patients. A pity because this was a promising treatment.
I agree. This is proposed as a disease modifying treatment. There is no way to assess that over such a short period. Unfortunately this drug company is bleeding cash and can't afford to put resources into a longer trial or pursue the potential of this drug.
The development stage biotechs are always bleeding cash. So now they're switching attention to something that is not as far along. Just no excuse.
The cash strapped company has just raised $ 200 million from a small group of professional investors with experience of new drug development. The cancer drug needs a relatively short low cost phase 3 to license and would then generate the sort of revenue that means it is not a cash strapped company and could afford a proper phase 3 over a 2 year trial.
It was a phase 2 trial and met all of its primary endpoints. It will cost a small fortune to do a phase 3 and prioritising the cancer drug will fund that phase3
They are not currently planning a phase 3: inhibikase.com/investors/se... "will pause further development of risvodetinib as it focuses its resources on advancing lead program IkT-001Pro in pulmonary arterial hypertension (“PAH”) and will consider its strategic options for the risvodetinib program."
>met all of its primary endpoints.
Uh-huh: "The primary endpoints of this trial were safety and tolerability"
But: "did not demonstrate an improvement in the top hierarchical efficacy measure, which was the sum of Parts 2 and 3 of the Movement Disorder Society Universal Parkinson’s Disease Rating Scale (“MDS-UPDRS”) at any dose group (50mg, 100mg or 200mg) versus placebo"
A disappointing result and they responded accordingly.
> prioritising the cancer drug
It is not a cancer drug. PAH is not cancer.
Sorry, I cannot respect a company that does a trial that is so obviously inadequate that an onlooker such as myself could say so ahead of time. Good luck to you if you are invested. Taking this one off my watch list.
Yes. Sorry PB - slightly casual referencing. IKT-001Pro for PAH is a cardiac drug. Only IKT-001Pro for CML is a cancer drug. Both require relatively short development times - relative to a disease modifier liket risvo - which might need 5 years in total (I would have thought a minimum of 2 years clinical time, plus set up , analysis and publication time
You have commented before about 12 weeks, and I have commented before that it was a phase 2 trial. As such, it plainly succeeded and met all of its primary endpoints. So there was nothing inadequate about it. It was 100% fit for purpose, and avoided wasting resources looking for positive therapeutic benefits it couldn't utilise at that stage of development. Of course, I'm not denying IKT HOPED for a positive symptomatic result, akin to the unblinded early partipants. They were HOPING that it would demonstrate symptomatic relief - they could licence for that, and then after 5 years of "in the field" trials, if the drug users appeared to progress less than others, they could licence for disease modification
That "on the cheap" "round the back door" option, affordable by cash-strapped micro biotechs like IKT, is no longer available So its fair to say it was a DISAPPOINTMENT . But that's not a failure. And it's not how the company described it in its 8k filing.
"Analysis of alpha-synuclein pathology using skin biopsy suggests a treatment dependent reduction in neuronal alpha-synuclein deposition in cutaneous nerve fibers across all doses."
In the circumstances, they have pause development of Risvo, for which they had run out of money, and which probably needs 3-5 years and north of $200 million, in favour of another drug with a shorter development time, lower cost, and for which enough money was recently , specifically raised.
That pause seems sensible (utterly unavoidable). 4 obvious strategic options suggest themselves - I'll put them in my next response
The strategic options are
1) dump it because its a failure
2) Sell it to a bigger pharma for them to develop
3) Some sort of partnership arrangement with big Pharma
4) wait until they have funds flow from IKT-001Pro, and resume development themselves
You have assumed they picked No1. I very much doubt it, looking at the pipeline section of the website. I doubt they are so cash-strapped they can't afford to update that. If I were IKT, and I were looking at option 4 (or indeed 2 or 3), and I could raise the money ( a big IF - although a relatively small amount of money) I would run open-ended, open label trials of maybe 50-100 participants. They wouldnt get it licenced, but they would tell you whether its worth investing in phase 3
Given recent regime changes at Washington and Kennedy junior, I would think they probably want any such activities to be in Europe. That probably applies to the IKT-001Pro trials as well
IKT' description of IKT-001Pro
(Very odd - the system kept having a problem with the page when I tried to add this to my other post)
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