Novo Nordisk: Data på CagriSema fra fase 3
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Bagsværd, Denmark, 20 December 2024 - Novo Nordisk today announced headline results from REDEFINE 1, a phase 3 trial in the global REDEFINE programme. REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo, all administered once-weekly. The trial included 3,417 randomised people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo.
The REDEFINE 1 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 57.3% of patients treated with CagriSema were on the highest dose compared to 82.5% with cagrilintide 2.4 mg and 70.2% with semaglutide 2.4 mg.
When evaluating the effects of treatment if all people adhered to treatment1, people treated with CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone. In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.
When applying the treatment policy estimand2, people treated with CagriSema achieved a superior weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg and 3.0% with placebo.
In the trial, CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
"We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide in monotherapy in the REDEFINE 1 trial. This was achieved even though only 57% of patients reached the highest CagriSema dose," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. "With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema."
The results from the second pivotal phase 3 trial, REDEFINE 2, in adults with type 2 diabetes and either obesity or overweight are expected during the first half of 2025.
About CagriSema
Once-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby help people eat less and reduce their calorie intake.About the REDEFINE clinical trial programme
REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. Additional phase 3 trials are ongoing.REDEFINE 1 - a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,400 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.
REDEFINE 2 - a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight.
REDEFINE 3 - an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes.
REDEFINE 4 - a 72-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 72,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.Contacts for further information
Media:
Ambre James-Brown
+45 3079 9289
[email protected]Liz Skrbkova (US)
+1 609 917 0632
[email protected]Investors:
Jacob Martin Wiborg Rode
+45 3075 5956
[email protected]David Heiberg Landsted
+45 3077 6915
[email protected]Sina Meyer
+45 3079 6656
[email protected]Ida Schaap Melvold
+45 3077 5649
[email protected]Frederik Taylor Pitter
+1 609 613 0568
[email protected] -
Novo lever ikke op til egne forventninger i kursfølsomt studie - aktien mister 700 mia kr
20/12 11:56
(Opdateres)
Novo Nordisks imødesete data for vægttabshåbet Cagrisema lever ikke op til medicinalselskabets egne forventninger.
Samlet har lægemiddelkandidaten i fase 3-studier vist et vægttab på 22,7 pct. over 68 uger.
Håbet i markedet og i øvrigt også fra Novo selv har været, at Cagrisema giver et vægttab på mindst 25 pct.
Novo-aktien brager da også ned efter resultaterne. Aktien falder med hele 20,5 pct. til 588,50 kr. og trækker dermed også C25-indekset tungt ned.
Faldet svarer ifølge MarketWires beregninger til et dyk i markedsværdien på tæt på svimlende 700 mia. kr.
.\˙ MarketWire
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NORDEA ANALYST MICHAEL NOVOD:
"While missing the 25%/25%+ weight loss expectations, we
believe the severe share price reaction is overdone."
"Despite the disappointing results, CagriSema is still the
best weight loss reported in a Phase 3 trial, while the
tolerability profile was in line with stand-alone GLP-1 and
slightly better than what was seen with Wegovy.
"Hence, that only 57% of patients got to the highest dose of
Cagrisema was likely not due to tolerability issues (one can
then speculate why, but it may have been driven by patients
simply stopping when getting to a satisfactory weight loss).
"With this in mind, we are confident that Novo can also
deliver higher weight loss with Cagrisema in such a trial." -
SIMON BAKER, HEAD OF GLOBAL BIOPHARMA RESEARCH AT REDBURN
ATLANTIC IN LONDON:
"(The weight loss) is considerably lower than the 25% most
were expecting, based on the company's modelling commentary.
"(...) around 23% is probably commercially sufficient longer
term, but inadequate on the day, hence the very sharp drop in
the stock.
"Also of note is that only 57% reached the highest dose,
which will lead to speculation about tolerability despite the
benign language in the press release. The 27% drop (in the share
price) is completely out of proportion fundamentally, but
positioning around this event was huge and it will take a while
for this to stabilise." -
UBS ANALYST JO WALTON:
UBS forecasts 70%
probability of $13bn incremental peak sales, which we value at DKK 34.8/share, 7.3%
of total NPV. As we highlighted in our CagriSema preview a worst case result would
be limited differentiation vs Zepbound and could suggest -9% downside to NPV. We
typically see stocks react 2-3x NPV on clinical trial readouts, which has been reflected in
the market reaction today. -
Novo/Jyske Bank: Kursreaktion virker som overreaktion
20/12 15:15
Kursreaktionen i Novo Nordisk efter offentliggørelsen af forsøgdata for Cagrisema er en overreaktion, vurderer Jyske Bank i en analyse efter meldingen om, at
Cagrisema viste et vægttab på 22,7 pct., mens markedets forventninger lå på 25 pct.
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Det er en voldsom reaktion og måske også lige til den gode side rent kursmæssigt. Reaktionen svarer til, at markedet lægger Cagrisema helt i graven på fedmeområdet, skriver bankens senioranalytiker Henrik Hallengreen Laustsen og han anser det som overreaktion.
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Det skuffende resultat kan delvist hænge sammen med, at blot 57 pct. af patienterne har opnået den høje dosis, som følge af mulighed for an en fleksibel dosering, påpeger han
Det giver nogle usikkerheder omkring den sande styrke for produktet.
Henrik Hallengreen Laustsen mener det store spørgsmål er, hvorfor den fleksible studieprotokol førte til, at blot 57 pct. fik den den høje dosis.
Han mener, der er to mulige svar.
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En positiv årsag er, at patienterne er tilfredse med et vægttab på 22 pct.
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Den negative årsag er, at patienterne har oplevet bivirkninger, som har gjort, at de er stoppet inden.
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Sandheden er uvis, men ligger nok et sted imellem de to. Kursreaktionen indikerer, at markedet tror på den sidste forklaring, siger han.
Ved 15-tiden fredag falder Novo Nordisk-aktien med 21 pct. til 588 kr. svarende til en værditab på knap 700 mia. kr. siden torsdag. Man skal dog ikke længere tilbage end til august 2023 for at finde kursniveauer under fredagens niveau.
Jyske Bank har anbefalingen "køb" og et kursmål på 1000 kr. for Novo-aktien.
.\˙ MarketWire
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Goldman Sachs: Tror det vil lykkes for CagriSema - ser betydelig opside for Novo Nordisk efter kurskrakket
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