1. Is this a candidate for ohm’s list? Since it

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1. Is this a candidate for ohm’s list? Since it is an autoimmune disease with inflammation, looks to a layman like a good candidate.

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Someone a little while ago asked me about Primary sclerosing cholangitis. I took a look at it and leronlimab looked like it would help. I put it on my list of diseases to do a deep dive on. I definitely need to start going through that list, off hand that list might hit 100 after that.

The drug Iqirvo's mechanism of action is as a PPAR agonist (elevates PPAR). PPARy is on the regulator list and leronlimab would upregulate it. PPAR regulates fat and glucose uptake and preferentially causes the conversion to brown (good) fat.

One example showing CCR5 blockade elevating PPAR.

Maraviroc attenuates trauma-hemorrhage-induced hepatic injury through PPAR gamma-dependent pathway in rats

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2. When a MASH/NASH trial is undertaken, might participants with diseases like PBC be included (or at least not excluded) so that this disease could possibly be incorporated into the subsequent FDA approval?

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Almost certainly primary biliary cholangitis will be an exclusion criteria. The FDA likes a clean trial without to many other factors and we certainly don't want anything confounding results.

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3. $11,500 for a one month’s supply – I don’t remember what ohm’s estimate was for Leronlimab, but this seems to be a pretty significant price for a drug that presumably is less efficacious than LL.

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At one point I promoted $32,000 a year and Nader changed the price from $120,000 a year to $32,000. That price would have meant a good profit while making the drug competitive and allowing at least some people to afford it off label. Once we made the distribution deal with 50% going to the distributor, understandably the price went to $64,000 a year. Still less than half the price of Iqirvo.

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Since the FDA appears to be willing to give accelerated approvals (and with only 161 patients in this trial) in liver disease trials, what is the likelihood of that for Leronlimab? It should at least encourage the company to include an interim analysis during the trial. I wonder if they will include interim analyses in all trials.

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Whether you want to set up for an interim analysis pre-trial is going to be dependent on trial size and expected level of effect. A data and safety monitoring board could recommend a full CRO interim analysis if the boards own internal analysis shows great results.