Babba, Interesting. I think I have covered it at the fringe in passing before but certainly not thoroughly!
Also for sure, a couple of hours study aint going to really cover it in any sort of depth but high level at least, it actually does sound ok. It is very early stage of course, as we all know, anything just leaving pre clinical stage and on to Phase 1 has a few years to go!
This is what I've always said, one day there genuinely will be some competition but I believe the window of opportunity for us with iPPS will be fairly substantial!
The market is simply huge.
So in a nutshell, Proteases are basically Enzymes. Enzymes breakdown proteins. This class of drug you have posted essentially attempts to inhibit the action of proteases. In other words they attempt to disrupt the unwanted biological processes. So for example, find (or build!) a Protease Inhibitor to bring down inflammation or effectively slow down cartilage degradation.
There is some evidence that certain proteases are really efficacious in certain roles and the FDA are certainly looking at this whole area more closely. Not only that but there have been some successful protease based drugs, some have been out there for quite some time, check out Table 1.
1
One of the above, as an example, Zenpep, has a 7.7 rating out of 10. Most people don't experience side effects with this drug.
Another example is Metalyse which has some three times the number of patients experiencing the positive end point against not utilising the drug. Again, some will experience side effects etc. However, importantly, "...patients taking TNK don't have a better functional outcome, the phase 2b CHABLIS-T II trial showed".
2In this particular case timing seems to be very important:
"Evidence shows IV TNK is noninferior to alteplase in patients with acute ischemic stroke presenting within 4.5 hours after stroke onset. However, only a very limited number of patients receive IV thrombolytic treatment within this time frame, so efforts are underway to expand that time frame".
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So this study you have posted about Babba has a route of administration being Intra-articular. This has it's own set of disadvantages, painful application, possible infections and single site targeting to name a few.
Of course a drug for OA involving proteases may be really effective but that's what the clinical studies are there for, to show the positive effects against placebo and determine if there are any safety issues. This will take them some time! That's where we already know a lot about PPS...it's been out there for decades already. We just have to start it (P3) and complete it...
The super thing for us is that once our P3 starts, it ain't going to be YEARS away for the readout...it will be months! The actual trial (subject to approval) will have a read out after 6 months (Day 168) ...yes the majority, if not all, patients have to reach that point, but if the data holds up like it has with 005...like it has with 008 and like it has with the other studies and even SAS and EAP....well that's worth waiting for and that shouldn't be all that far away.
Ahh what's that famous saying:
Be on the watch out for competition...we want to hear about it...to compare, understand and be aware of what's out there.
Thanks for posting and sharing it with us.
Ref
1)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4503466/2)
https://www.medscape.com/viewarticle/tenecteplase-effective-stroke-later-time-window-2024a10004k5?form=fpf
(20min delay)