- Danish drugmaker Novo Nordisk on Thursday unveiled positive clinical results from two Phase 3 trials of its diabetes drug semaglutide, strengthening its case for the experimental oral version of the glucagon-like peptide (GLP)-1 analogue.
- In the first, a trial called PIONEER 4, once-daily semaglutide proved non-inferior to Novo's on-market GLP-1 Victoza in reducing blood sugar levels in patients with Type 2 diabetes inadequately controlled by metformin. Semaglutide also led to statistically superior weight loss than Victoza.
- Data from the second study, dubbed PIONEER 7, showed a significantly greater proportion of patients receiving dose-adjusted semaglutide achieved target HbA1c levels below 7% than those given Merck & Co.'s blockbuster drug Januvia.
Results from PIONEER 4 and 7 add to positive data from two other Phase 3 studies which read out earlier this year, and mark another step in Novo's expansive clinical program (see chart below) for oral semaglutide.
The GLP-1, which is already approved in the U.S. as an injectable drug under the brand name Ozempic, is key to Novo's plans for maintaining a leading position in diabetes.
Currently, Victoza (liraglutide) is the leading GLP-1 by market share in the U.S. — by a hair. Prescription data from Cowen, an investment firm, show Eli Lilly's rival Trulicity (dulaglutide) has steadily closed in on Victoza, and now trails Novo's drug by only a couple percentage points in new prescription share.
Both drugs are injectables, although Victoza is administered once-daily while Trulicity can be used once weekly.
With semaglutide, Novo hopes to position the injectable Ozempic version as a competitive once-weekly GLP-1 option, while transition once-daily patients to the oral, and more convenient, form.
To support approval of the oral drug, Novo has assembled a line-up of ten Phase 3a studies that will collectively enroll nearly 9,000 diabetes patients. With results from four now in hand, Novo can better make the case for oral semaglutide's competitiveness in what has become a crowded market.
Results from the six other studies, including a large cardiovascular outcomes trial, are all expected this year.
Currently, GLP-1 drugs account for 12% of the total diabetes market by value, according to data from Novo. The drugmaker expects that figure to grow, although SGLT-2 inhibitors like Eli Lilly's Jardiance (empagliflozin) will present a challenge.
More than its principal competitors Sanofi and Eli Lilly, Novo's business is highly dependent on its franchise of diabetes drugs. Growing pushback from payers on pricing in the U.S., particularly for insulin products, as well as increased competition among each of the three, has weighed on Novo.
Most recently, reports emerged that Novo could be considering cutting thousands of jobs and may trim long-term financial guidance. Novo has not commented on what it terms "speculation."
Shares in Novo rose by nearly 3% by value on the New York Stock Exchange Thursday morning, before falling back to trade up by about 1.8%.
Phase 3 studies testing oral semaglutide in Type 2 diabetes
|Study||Comparator (or aim)||Patients enrolled or targeted||Status|
|Pioneer 1||Placebo (monotherapy)||703||Positive readout in February|
|Pioneer 2||Jardiance||816||Positive readout in May|
|Pioneer 3||Januvia||1,860||Results expected by the end of June|
|Pioneer 4||Victoza, placebo||711||Positive readout in June|
|Pioneer 5||Placebo (in patients w/renal impairment)||324||Results expected in Q3|
|Pioneer 6||Placebo (cardiovascular outcomes)||3,176||Results expected in Q4|
|Pioneer 7||Januvia (dose escalation)||504||Positive readout in June|
|Pioneer 8||Placebo (add-on to insulin)||720||Results expected in Q4|
|Pioneer 9||Victoza, placebo (in Japanese patients)||230||Results expected in Q4|
|Pioneer 10||Victoza (in Japanese patients)||336||Results expected in Q3|
SOURCE: Novo Nordisk, clinicaltrials.gov