Novo’s oral GLP-1 looks sweeter

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Another day, another diabetes development. In the GLP-1 alternative delivery game Intarcia Therapeutics gained an edge last week with its ITCA 650 implant, but Novo Nordisk is close behind with its oral semaglutide project.

The Danish company has announced that a phase IIIa programme with its contender, OG217SC, will start next year. The question could end up being one of convenience: which is more user-friendly – a once-daily pill or an implant that lasts for 12 months?

Pros and cons

If Intarcia’s and Novo’s projects are approved they could grab market share from existing GLP-1s – as well as being more convenient than a daily or weekly injection, ITCA 650 could also solve the issue of compliance, which would still hit oral semaglutide.

But the implant has its own disadvantages: it will be marketed as a drug, but might need a more device-like marketing strategy, including special training for doctors covering how to deliver the implant.

Before any marketplace showdown, of course, both need to prove their worth in phase III trials, and ITCA 650 is already looking promising. Most recently it outperformed the best-selling oral antidiabetic, Merck’s DPP-IV inhibitor Januvia, in the Freedom-2 trial on blood sugar and weight loss endpoints (Besting Januvia sets Intarcia up for bigger deal – or not, August 19, 2015).

Intarcia is expected to file ITCA 650 for approval in the first half of 2016.

Seven studies

Novo, meanwhile, still has some way to go before it reaches this point. It is planning seven studies as part of its phase III Pioneer programme, the first of which will start in the first quarter of 2016, evaluating oral semaglutide dosed at 3mg, 7mg and 14mg compared with Januvia. The other trials are also slated to start next year, but the company did not give further details.

Citi analysts forecast peak sales of $1bn, but this is before taking into account OG217SC’s chance of success, which they estimate at just 22%. Novo seems more confident, recently earmarking $2bn for new production facilities that will manufacture oral semaglutide, among other things.

The company is looking for new candidates as it faces increasing competition for its once-daily injectable GLP-1 Victoza. It had been trying to expand Victoza into type 1 diabetes, but these plans were recently scuppered (Novo gives up on Victoza in type 1, August 25, 2015).

As a result Novo will be hoping that the convenience of a daily semaglutide pill will win the day, while Intarcia will be pushing its time advantage, should its implant be the first non-injected GLP-1 to the market.

Both agents are well ahead of the pack, which does not seem to have progressed much since EP Vantage’s last analysis over a year ago. Perhaps both ITCA 650 and oral semaglutide will have time to carve out their own niches – at the cost of the current injectables.

Non-injected GLP-1 agonists in development
Company Project Routes of admin Status Clinical trials
Intarcia Therapeutics ITCA 650 (exenatide synthetic) Implant Phase III NCT01455870; NCT01455896;
Novo Nordisk (Emisphere Technologies) OG217SC (semaglutide oral) Oral Phase III Seven-trial Pioneer programme
Oramed Pharmaceuticals ORMD 0901 (exenatide synthetic) Oral Preclinical
Midatech GLP-1 Research Project Oral Preclinical
Novo Nordisk (Merrion Pharmaceuticals) NN9925 Oral Abandoned in Phase I in 2011
Eli Lilly/Amylin Transdermal Exenatide Transdermal Abandoned in phase I in 2011

To contact the writer of this story email Madeleine Armstrong in London at madeleinea@epvantage.com or follow@medtech_ma on Twitter

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