Another strong showing for oral semaglutide leaves Novo with positioning questions


Six down – four to go. Today’s announcement from Novo Nordisk of positive results in the sixth of 10 trials for oral semaglutide marks another step towards approval for Novo’s lead pipeline asset, but will do little to allay fears that the oral GLP-1 agonist could cannabalise sales of injectable Ozempic. The Pioneer 5 study showed that oral semaglutide’s previously demonstrated safety and efficacy held up in a new patient population of type 2 diabetics with moderate renal impairment. The pill also generated impressive weight loss; it is this efficacy that could cause Novo problems. It had been thought that oral semaglutide would be used after patients had failed on other oral treatments, such as metformin, and before injectables such as Ozempic. But with little between the two Novo products on weight loss measures, and what is expected to be a lower price point for an oral versus injected product, Bernstein analysts have argued that physicians could be tempted to keep patients on the cheaper oral treatment for longer. Ozempic is already struggling, and earlier this month reported disappointing second-quarter sales, so any threat to Novo’s weekly injectable, including an internal one, will be another unwelcome blow to a company already reeling from falling US prices. 

Oral semaglutide phase III trials   
      Results (intent-to-treat basis)  
Study  Setting  N HbA1c reduction Weight loss Trial ID 
Pioneer 1  Vs placebo  703  Statistically superior
for all 3 doses
Superior for highest
dose only*
Pioneer 2  Vs Jardiance  816  Statistically superior Not statistically superior** NCT02863328 
Pioneer 3  Vs Januvia  1,860  Superior for highest
2 doses
Statistically superior
for all 3 doses
Pioneer 4  Vs Victoza  690  Non-inferior*** Statistically superior NCT02863419 
Pioneer 5  Vs placebo; moderate
renal impairment  
324  Statistically superior Statistically superior NCT02827708 
Pioneer 6  CV outcomes  3,176  Data due Q4 2018 NCT02692716 
Pioneer 7  Flexible dose
adjustment vs Januvia 
500  Statistically superior Statistically superior NCT02849080 
Pioneer 8  Vs placebo in
insulin-treated patients 
720  Data due Q4 2018 NCT03021187 
Pioneer 9  Vs placebo or Victoza;
Japanese patients  
240  Data due Q4 2018 NCT03018028 
Pioneer 10  Vs Trulicity, combination
study in Japanese patients 
455  Data due Q3 2018 NCT03015220 
*Numerical superiority on a per-protocol basis for all 3 doses;
**statistical significance hit at 52 weeks, but not at 26 weeks;
***numerical superiority on a per-protocol basis.




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