Happy New Year All !!!I am expecting 2023 to be an exciting year as 2022 was the go/no-go period for the ace in the hole - the modified formulation for OTENA.
Sure ... nothing is a slam dunk in drug development ... but ... nothing at ATE could move forward until a determination was made ... crystalline or amorphous? They kept it hidden really well - hats off !!!
Even the path for chronic pain was on-hold, waiting for this determination. I think chronic also has one additional determination ... being ... are we a daily chronic pain drug or are we for flare-ups only? That depends on the following ... is a pause requried between chronic regimens and how big does that pause have to be to reset the liver?
Did IBD need to wait as well ? Not sure why this one paused and a Q2 update never came. Then the update was moved to P3 and further to P4. As we best understand now, a decision was made. Are we waiting for the patent to be completed before we get the update? Most likely!
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We know the path for acute pain, so I won't put much time into that discussion.
The only think I want to say here is ... 40.4% is the likely switch rate to our OTENA-acute if it proves to be successful. That's 50% of post-op and 30% of all other indications we are chasing. Much more inline with what I expected than the 15% we were eyeing for chronic pain. Then again - the patent for the old chronic pain drug was only going to be 5 years in the USA - hardly any time to make a full switch-over for the patient population. Maybe that's why we were looking at only 15% back then.
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For chronic pain, we learned something new in 2022 ...
"Using anti-inflammatory drugs and steroids to relieve pain could increase the chances of developing chronic pain ..."
Interesting! If true, having protective and reparative effects from H2S (at the cell level) could play very nicely into our hands. We have a chance to buck this trend, IMO.
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The other thing we learned in 2022 was ... new IBD patients are also using painkillers at the same time. Watch closely for our IBD update to see where we are positioned and what our drug can do for pain. We know ATB-429 was an iron scavenger (closely related to pain relief) ... so ... what will the new IBD drug look like? Can it replace the need for additional pain medication? Will OTENA be a bettter replacement if pain medications are still needed? That's what I want to know.
"While initiation of advanced therapies reduces intake of nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and opioids, patients with newly diagnosed Crohn disease (CD) or ulcerative colitis (UC) often still require concurrent pain medications along with advanced therapies and even increased intake of neuromodulators, according to study findings published in BMC Gastroenterology."
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Anyway ... here we go into 2023.
A very important year to kick off OTENA in a more friendly form.
A liver-friendly form ???? TBD
Happy New Year All !!!!