This is still some way off the 25% target. But Mr Thomsen points out that patients were only on the therapeutic 2.4mg dose for the final four weeks of the trial, and that weight loss does not appear to have plateaued.
He believes that in a year-long pivotal trialwere likely to see 25% weight loss or even greater. My prediction, that we could have bariatric surgery-like level of efficacy, seems to be fully on track.
A phase III study of sema/AM833 in obesity is set to begin next year. The combo could also be tested in Nash and perhaps even severe diabetes, Mr Thomsen adds.
He thinks a cardiovascular outcomes study with the combo will not be needed, because of the apparently benign side-effect profile of AM833. A large outcome trialof sema in obesityis already ongoing. Regulators might have other ideas, of course, particularly as Novo envisions its obesity therapies being taken on a chronic basis.
Giving GIP-GLP the slip
The tolerability of sema/AM833 was apparently only one factor behind Novos recent decision to ditch two other obesity projects: its glucagon and GLP-1 co-agonist; and its glucagon, GLP-1 and GIP tri-agonist.
Mr Thomsen hints that serious toxicity concerns might also have influenced the move. The data tell me that some things are going on that you dont want not just gastrointestinal [side effects]. Were going to publish these data and youll see its not totally trivial.
This might mean bad news for Lilly, which is pinning its hopes on a GIP/GLP-1 agonist, tirzepatide. As well as a huge pivotal programme in diabetesthat is set to start reading out later this year, Lilly is also conducting a phase III trial of the project in obesity, Surmount-1, with data due in 2022. A spokesperson for Lilly declined to say what level of weight loss the company hopesto see.
As for adverse events, the Lilly spokesperson pointed out that in phase IItirzepatide had a similar safety profile to GLP-1 agonists, with temporarymild to moderate gastrointestinal effects most commonly reported.
Companies evaluating glucagon/GLP1 combos include Astrazeneca with cotadutide and Merck & Co/Hanmi with efinopegdutide, previously known as HM12525A. Both arebeing developed in Nash, although J&J trialled the latter in obesity before handing it back to Hanmi last year.
Energy in, energy out
While sema, AM833 and GIP all work on the appetite suppression side of weight management, glucagon agonists are involved in energy expenditure.
Novo hopes to find new mechanisms to spur the latter, Mr Thomsen believes. I think were getting close to maxing out on appetite modulation.
He highlights uncoupling protein UCP1, found in the mitochondria of brown fat tissue, which burns off energy to generate heat. Mimicking this protein could be a way of increasing energy expenditure, although work on this target is still very early.
More immediately, it will be clinical and commercial success with sema and, eventually, the combo, that determines whether Novo can become a force in obesity.
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Novo adds weight to its obesity goals - Vantage
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