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Novo Nordisk's oral GLP-1 analogue looks set for phase III

Semaglutide said to be one of the firm’s most promising prospects

Novo Nordisk headquarters 

An oral version of Novo Nordisk's GLP-1 analogue semaglutide, billed as one of the company's brightest pipeline prospects, has sailed through a phase II trial.

The new candidate - called OG217SC - is a follow-up to a once-weekly injectable formulation of semaglutide, which cleared several phase III trials last year and started a sixth and final pivotal trial last December.

If the injectable version is approved it will have to compete with a number of similar products on the market - notably AstraZeneca's Bydureon (exenatide), GlaxoSmithKline's Tanzeum/Eperzan (albiglutide) and Eli Lilly's recently-launched Trulicity (dulaglutide). 

The oral version could however be the first of its type in the GLP-1 analogue class, according to analysts, who suggested that - while something of a wildcard - OG217SC could sit alongside Novo's new obesity therapy Saxenda as having significant sales potential. 

The latter has been tipped as a $1.4bn product, although the poor performance by recent entrants in the obesity sector has meant that prediction is widely acknowledged as speculative.

Novo's phase II trial compared once-daily OG217SC with placebo or once-weekly injectable semaglutide in around 600 people with type 2 diabetes over a 26-week period. 

Those given OG217SC showed dose-dependent improvements in haemoglobin A1c - a measure of glucose control over time - that ranged from 0.7% to 1.9% after 26 weeks. Patients treated with subcutaneous semaglutide or placebo achieved improvements of 1.9% and 0.3% respectively.

Moreover, patients on the highest dose of oral semaglutide (40mg/day) as well as those given the 1mg subcutaneous injection lost an average of around 6.5kg of weight from the mean baseline weight of 92kg, while the placebo group lost around a kilo.

"This clinical proof of concept marks an important milestone for oral peptide therapy within the field of diabetes," commented Mads Krogsgaard Thomsen, Novo's chief scientific officer. 

Last month, he suggested the project hinged on showing that the oral form could "match an injectable counterpart in terms of clinical safety and efficacy in a way that is commercially viable for the company to develop in phase III."

The first part of the proviso seems to have been met, and the company says it will now discuss the potential for advancing OG217SC into phase III with regulatory authorities. Analysts have suggested however that the challenges posed by oral delivery of peptides could mean that a second phase II trial may be required.

Article by
Phil Taylor

23rd February 2015

From: Research

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