Let's take a look at the GLP-1 drug development landscape (including drugs that target related hormones), because this hot area illustrates the fortunes of the pharmaceutical sector quite starkly.
As everyone knows, Novo Nordisk (NVO) enjoyed spectacular success with semaglutide (Ozempic/Wegovy), and its effects on weight loss have been established to an undeniable degree.
Its effects on many other things are still under investigation – I blogged about it Beforeand it will most certainly be the case again, as it is a vast and rapidly developing field in itself.
But when it comes to weight loss, a year or two ago, Eli Lilly (LLY) was working on an approval for obesity. trizepatide (Mounjaro/Zepbound), which was already vigorously prescribed off-label.
This one affects both GLP-1 and GIP receptorsby opposition to semaglutide. Lilly was also go forward on a small molecule GLP-1 agonist (or forglipron), administered orally unlike the injected peptides which have predominated in this field.
Boehringer Ingelheim was another GLP-1 peptide from clinical trials, in partnership with Zealand. Pfizer (PFE), meanwhile, offered a small-molecule GLP-1 agonist (also administered orally), danuglipron. So it looked like there was going to be quite a pile-up if everyone came to market in a relatively short period of time.
Well, drug development, yes. Let's start with Amgen, which is a little behind the leaders in this field, but with the hope that their different mechanism will eventually prevail.
They have published some of their phase I data, and it's a mixed bag. They definitely see a lot of weight loss and on a less frequent dosing schedule than other GLP-1 medications, which is a good thing.
But a number of patients in the trial stopped treatment (perhaps because of a notable number of gastrointestinal problems), and the drug's effects on lipids were difficult to understand (cholesterol and triglycerides were decreased in a primate model, but the effects on lipids were reduced). human subjects were everywhere).
A phase II trial is supposed to be made public in a few months, and financial analysts who were besiege Amgen management on the final earnings call, we'll just have to wait for those numbers.
Pfizer's candidate had an even more difficult time. In Decemberthe company said so would not move forward the idea of twice daily oral dosing due to an unacceptably high dropout rate in their most recent clinical trial (gastrointestinal effects again).
They're moving forward with the once-a-day version, and those results will be released in a few months as well, so get your popcorn and big game nacho-making supplies ready when all these things arrive.
The Boehinger complex is in phase III, and I don't know when this one reads. Meanwhile, Roche (OTCQX: RHHBY) bought this domain in acquire CarmotAstraZeneca (AZN) to a candidate from a Chinese partner, and I haven't even mentioned Amgen's previous efforts, Regeneronand others on new mechanisms that are not GLP-1/GIP.
This is very interesting, and I wish everyone good luck, but the success rate of obesity drugs with new mechanisms of action is not encouraging.
Remember, GLP-1 agonists were on the market for years, causing weight loss in diabetic patients (as a side effect, more or less, of blood sugar control) before becoming more widely used.
And Lily? Well, for now it seems like the field is clear for them, which is why their stocks have seen a big decline recently (and why they are now among the top ten companies in the world by market capitalization!)
Mounjaro's Zepbound version has been approved for obesity, and it is sell every piece that they can produce. The company is build frantically more production capacity and are looking to make the most of this moment before the field gets complicated again.
This story will surely take more twists and turns as the year goes on, though – I'm not even going to suggest what. You'd have to think that the Lilly drug will be pretty strong competition for the “Hey, we also have a GLP-1 peptide” type of people that are still in the testing phase, but the clinic (and the market) will decide that – presumably . ..
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