Thread by @iamcrsmith

Starting a thread on $ITRM because I see it getting pumped all over, and I think a lot of people are set up to get hurt. I am an emergency department pharmacist who treats UTI's, both complicated and uncomplicated, all day long. I'm also on my hospital's ID Stewardship Committee

$ITRM's sole product is sulopenem/probenecid - a thiopenem antibiotic combined with an old gout medicine which is actually being used here to increase the half life of the antibiotic.

Sulopenem is not new. It was developed by Pfizer in the mid-1990s but development was discontinued due to high development costs and sulfurous odors when dosed in human volunteers. $ITRM licensed sulopenem in 2015 and is investigating its use in 3 Phase III trials.

These Phase III trials include uncomplicated UTI (uUTI), complicated UTI (cUTI), and complicated intra-abdominal infections (cIAI). The uniqueness of sulopenem compared to its carbapenem cousins is it has been manufactured as an oral tablet. All other carbapenems are IV only

SURE-1 is the Phase 3 trial where sulopenem/probenecid showed superiority to ciprofloxacin for quinolone-resistant uUTI's but DID NOT show non-inferiority to ciprofloxacin with quinolone susceptible pathogens

THIS IS A MASSIVE FAIL❗️

SURE-2, the study which evaluated sulopenem/probenecid in the setting of cUTIs, ultimately caused the stock price to crash when it could not reach non-inferiority compared to ertapenem w/ oral step down therapy.

The company does state that if asymptomatic bacteriuria patients are removed, the clinical response rates are the same. But the problem is that microbiologic response is still listed in the FDA's UTI treatment trial development guidance fda.gov/media/129531/d…

This is going to be a huge hurdle to jump for FDA approval. But let's take the best-case scenario where the drug does get approved AND a few hospitals happen to get it added to their formularies (another hurdle in and of itself). Then what happens?

ANY hospital with an ID stewardship committee will immediately restrict the antibiotic, just for being in the same class as carbapenems. At our hospital, we require an ID consult for any carbapenem being used >48 hrs.

For the non-medical folks out there, hosptials restrict broad spectrum antibiotics to lower rates of resistance. We have plenty of studies showing that greater use of carbapenems leads to greater numbers of carbapenem resistant enterobacteraciae (CRE) - a major ID issue

I don't think I have to explain how ID stewardship KILLS the revenue streams to drug companies selling broad spectrum antibiotics. Also, I can guarantee you that #IDSA would throw this to the very back of their uUTI guidelines if they even recommend it at all

If you are going to comment that this stock is ripe for a short squeeze and that I can "have fun staying poor," then go back and look at Melinta Therapeutics (previously $MLNT). A company which was in a similar situation as $ITRM a few years ago.

$MLNT developed two unique broad spectrum antibiotics, Vabomere and Baxdela. Our hospital has not added Baxdela to our formulary and if anyone wants to use Vabomere, they need an ID consult. This is congruent with the other large teaching institutions I've interacted with.

$MLNT was delisted January 2020. And my fear is that the same will eventually happen to $ITRM. I'd ask the #AtlasTrading crew to please help me get this out to warn the many members who keep pumping this in the chat rooms. @MrZackMorris @ripster47 @PJ_Matlock @DipDeity @Pharmdca

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