Novo har 2 orale CB1r fedme stoffer i deres pipeline Der er tale om orale såkaldte små molekyler der er MEGET simpelt, let og billigt at producere i forhold til GLP1 stofferne. (store peptid molekyler)
Idet CB1r stoffer er så lette og billige at producere i meget store mængder, så vil sådan stoffer potentielt udvide hele fedme markedet ganske betragteligt. Både i forhold til dem der ikke kan li nåle. Men i særdeleshed også fordi de kan sælges signifikant billigere end ozempic/wegovy priser.
Novo har som nævnt 2 CB1r stoffer i deres pipeline. Det ene er Monlunabant som pt er i fase 2. Faktisk 2 forskellige fase 2 studier. Vi går og afventer resultatet af dem.
Novo har indenfor få dage opdateret protokollen til de 2 fase 2 studier. De har ændret Primary Completion fra "estimated" til "actual". Altså har de nu data.
Man kan se de 2 protokoller og ændringerne via nedenstående links
https://clinicaltrials.gov/study/NCT05891834?lead=Inversago%20Pharma%20Inc.&rank=1&tab=history&a=6&b=7#version-content-panel
https://clinicaltrials.gov/study/NCT05514548?lead=Inversago%20Pharma%20Inc.&rank=2
Næste uge er der en stor konference i Barcelona. EASD. Novo deltager på konference og vil bla præsentere flere detaljer fra Amycretin fase 1 studiet, samt prækliniske data fra INV347. INV347 er novos andet CB1r stof der pt er i fase 1.
Man kan læse mere om Amycretin og INV347 data via nedenstående indlæg jeg skrev for lidt tid siden.
https://proinvestor.com/boards/121266/
Jeg tror Novo i forbindelse med næste uges konference, udsender en børsmeddelelse med headline data fra Monlunabant.
Biotech/Pharma er per definition high risk I udviklingsfasen. Masse af studier rapportere dårlige data. Så der er absolut heller ingen garanti for der kommer gode data. Men der er måske lidt tegn på de i hvert fald ikke er direkte dårlige.
Der er tale om 16 ugers studier, og CB1r er ikke tiltænkt at være stoffer der kæmper med om de største vægttab. Mit bud er vægttab på 5-7%. Novo selv siger 15% vægttab i fase 3 studier (52-68 uger)
Men når jeg hælder mere til resultater er positive, så skyldes det den pludselig store interesse for stoffet, og det novo har fortalt.
Dagen efter Q2 afholdte novo traditionen tro et investor kald i London. Det kan høres her https://edge.media-server.com/mmc/p/fo8eytnc/
Monlunabant fyldt en del på den præsentation. Og novo udviklingschef Martin Lange fik også fortalt flere nye interessante informationer. Herunder at de forventer at starte 2 nye fase 2b studier senere i år. Ca 600 patienter i alt.
Martin Lange fortalte bla, at de forventer at inkludere wegovy som en aktiv comparator. Og de overvejer også at lave en arm med både wegovy + Monlunabant.
Så her får vi altså data at se, som måles direkte mod wegovy. Det vil give rigtig meget visibilitet for hele CB1r klassen. Og hvis vi så ovenikøbet får en arm med BÅDE wegovy + Monlunabant, så får vi vished for mulige synergieffekt som også ses ved GLP1 + amylin.
Det interessante er at dette investorkald foregik 8/8. Hvis man ser på det ene studies nu opdaterede protokol, så står der "actual primary completion" var den 13/6. Altså næsten 2 mdr før London præsentationen. Så når Martin udtalte sig som han gjorde, så var det med afsæt i han allerede havde ret detaljerende data fra fase 2 studiet. Og DERFOR mener jeg sandsynligheden for en positiv børsmeddelelse ser ganske fin ud.
Pt er der kun novo med CB1r i pipelinen. Selv præklinisk er der meget lidt i pipelinen. Umiddelbart er der ingen af de andre store pharma selskaber, herunder LLY der har CB1r.
Men HVIS novo begynder at rapportere flotte data, så øges spotlys på mekanismen også meget drastisk.
Umiddelbart så findes der kun ét andet børsnoteret selskab der har CB1r i pipelinen. Det er det lille biotech selskab Corbus Pharmaceuticals (CRBP)
Corbus har et CB1r stof, CRB-913 der ventes at starte fase 1 primo 2025. HVIS novo rapportere positive Monlunabant data, så vil det alt andet lige få en positiv afsmittende effekt på Corbus aktien. Det modsatte er naturligvis også gældende.
Analytikerne estimerer upside på 50-100% ved gode data, og 50% ned ved dårlige data.
Med afsæt i min egen analyse og risikovurdering, har jeg derfor de sidste par dage samlet mine første CRBP aktier op. Tanken er at holde dem hen over Monlunabant data. Hvad end de kommer næste uge eller senere. (Novo har generelt sagt Q3)
Så det er i udgangspunktet en kortsigtet high risk investering.
Ovenstående skal IKKE læses som nogen anbefaling. Biogtech investeringer er per definition high risk og langt fra for alle at investere i.
PS
Man kan fra side 31 af nedenstående IR præsentation se mere om CRB913
https://d1io3yog0oux5.cloudfront.net/_cf95197f7ed89d08013e2844bbd92941/corbuspharma/files/docs/Corporate_Presentation_August_20_2024.pdf
Idet CB1r stoffer er så lette og billige at producere i meget store mængder, så vil sådan stoffer potentielt udvide hele fedme markedet ganske betragteligt. Både i forhold til dem der ikke kan li nåle. Men i særdeleshed også fordi de kan sælges signifikant billigere end ozempic/wegovy priser.
Novo har som nævnt 2 CB1r stoffer i deres pipeline. Det ene er Monlunabant som pt er i fase 2. Faktisk 2 forskellige fase 2 studier. Vi går og afventer resultatet af dem.
Novo har indenfor få dage opdateret protokollen til de 2 fase 2 studier. De har ændret Primary Completion fra "estimated" til "actual". Altså har de nu data.
Man kan se de 2 protokoller og ændringerne via nedenstående links
https://clinicaltrials.gov/study/NCT05891834?lead=Inversago%20Pharma%20Inc.&rank=1&tab=history&a=6&b=7#version-content-panel
https://clinicaltrials.gov/study/NCT05514548?lead=Inversago%20Pharma%20Inc.&rank=2
Næste uge er der en stor konference i Barcelona. EASD. Novo deltager på konference og vil bla præsentere flere detaljer fra Amycretin fase 1 studiet, samt prækliniske data fra INV347. INV347 er novos andet CB1r stof der pt er i fase 1.
Man kan læse mere om Amycretin og INV347 data via nedenstående indlæg jeg skrev for lidt tid siden.
https://proinvestor.com/boards/121266/
Jeg tror Novo i forbindelse med næste uges konference, udsender en børsmeddelelse med headline data fra Monlunabant.
Biotech/Pharma er per definition high risk I udviklingsfasen. Masse af studier rapportere dårlige data. Så der er absolut heller ingen garanti for der kommer gode data. Men der er måske lidt tegn på de i hvert fald ikke er direkte dårlige.
Der er tale om 16 ugers studier, og CB1r er ikke tiltænkt at være stoffer der kæmper med om de største vægttab. Mit bud er vægttab på 5-7%. Novo selv siger 15% vægttab i fase 3 studier (52-68 uger)
Men når jeg hælder mere til resultater er positive, så skyldes det den pludselig store interesse for stoffet, og det novo har fortalt.
Dagen efter Q2 afholdte novo traditionen tro et investor kald i London. Det kan høres her https://edge.media-server.com/mmc/p/fo8eytnc/
Monlunabant fyldt en del på den præsentation. Og novo udviklingschef Martin Lange fik også fortalt flere nye interessante informationer. Herunder at de forventer at starte 2 nye fase 2b studier senere i år. Ca 600 patienter i alt.
Martin Lange fortalte bla, at de forventer at inkludere wegovy som en aktiv comparator. Og de overvejer også at lave en arm med både wegovy + Monlunabant.
Så her får vi altså data at se, som måles direkte mod wegovy. Det vil give rigtig meget visibilitet for hele CB1r klassen. Og hvis vi så ovenikøbet får en arm med BÅDE wegovy + Monlunabant, så får vi vished for mulige synergieffekt som også ses ved GLP1 + amylin.
Det interessante er at dette investorkald foregik 8/8. Hvis man ser på det ene studies nu opdaterede protokol, så står der "actual primary completion" var den 13/6. Altså næsten 2 mdr før London præsentationen. Så når Martin udtalte sig som han gjorde, så var det med afsæt i han allerede havde ret detaljerende data fra fase 2 studiet. Og DERFOR mener jeg sandsynligheden for en positiv børsmeddelelse ser ganske fin ud.
Pt er der kun novo med CB1r i pipelinen. Selv præklinisk er der meget lidt i pipelinen. Umiddelbart er der ingen af de andre store pharma selskaber, herunder LLY der har CB1r.
Men HVIS novo begynder at rapportere flotte data, så øges spotlys på mekanismen også meget drastisk.
Umiddelbart så findes der kun ét andet børsnoteret selskab der har CB1r i pipelinen. Det er det lille biotech selskab Corbus Pharmaceuticals (CRBP)
Corbus har et CB1r stof, CRB-913 der ventes at starte fase 1 primo 2025. HVIS novo rapportere positive Monlunabant data, så vil det alt andet lige få en positiv afsmittende effekt på Corbus aktien. Det modsatte er naturligvis også gældende.
Analytikerne estimerer upside på 50-100% ved gode data, og 50% ned ved dårlige data.
Med afsæt i min egen analyse og risikovurdering, har jeg derfor de sidste par dage samlet mine første CRBP aktier op. Tanken er at holde dem hen over Monlunabant data. Hvad end de kommer næste uge eller senere. (Novo har generelt sagt Q3)
Så det er i udgangspunktet en kortsigtet high risk investering.
Ovenstående skal IKKE læses som nogen anbefaling. Biogtech investeringer er per definition high risk og langt fra for alle at investere i.
PS
Man kan fra side 31 af nedenstående IR præsentation se mere om CRB913
https://d1io3yog0oux5.cloudfront.net/_cf95197f7ed89d08013e2844bbd92941/corbuspharma/files/docs/Corporate_Presentation_August_20_2024.pdf
6/9 2024 12:26 Helge Larsen/PI-redaktør 1
122148 Novo Nordisk to present new data from key diabetes and obesity trials at the 60th annual meeting of the European Association for the Study of Diabetes
Bagsværd, Denmark, 6 September 2024 - Novo Nordisk today announced the presentation of 21 abstracts (7 oral and 14 short oral presentations) at the upcoming 60th Annual Meeting of the European Association for the Study of Diabetes (EASD), which will take place from 9 to 13 September 2024 in Madrid, Spain.
In addition to the abstracts, data will also be presented in dedicated scientific symposia. These include results from the COMBINE clinical programme with IcoSema, a combination of once-weekly basal insulin icodec and once-weekly semaglutide, in people with type 2 diabetes, the FLOW trial evaluating semaglutide 1.0 mg on kidney outcomes in people with type 2 diabetes and chronic kidney disease, and amylin treatment for metabolic disease.
"Cardiometabolic conditions like diabetes, obesity, cardiovascular and kidney disease, all result from closely interlinked underlying risk factors and are among the most significant health challenges society faces today. Tailored treatment options that aim to holistically address these conditions are therefore needed," said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. "At EASD this year, we are showcasing new data from across our diabetes, obesity, cardiovascular and renal pipeline and portfolio, where we continue to push boundaries with the goal of advancing treatments in order to help more patients."
Summary of presentations
Accepted data at the 60th annual meeting of the EASD include the following oral and short oral presentations. Accepted abstracts include preliminary data that may be subject to change in final published manuscripts. Dates and times of the presentations and the abstracts can be found on the EASD website.
EASD scientific symposia
Amylin for treatment of metabolic diseases (10 September 2024; 17.15-18.15 CEST)
FLOW: the first dedicated kidney outcomes trial with a GLP-1 RA, semaglutide, in patients with T2D and CKD (11 September 2024; 09.00-10.30 CEST)
Taking a COMBINEd approach: insulin icodec and semaglutide (11 September 2024; 17.30-18.30 CEST)
EASD oral and short oral presentations
Diabetes
Awiqli® (once-weekly basal insulin icodec)
Impact of age on the efficacy and safety of once-weekly insulin icodec versus once-daily insulin in type 2 diabetes (ONWARDS 1-5)
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline sodium-glucose cotransporter-2 inhibitor use: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist use: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes by ethnicity and race: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: ONWARDS 1-5
No evidence of increased physical activity-related hypoglycaemia with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes: ONWARDS 1-5
No evidence of increased physical activity-related hypoglycaemia with once-weekly insulin icodec versus once-daily basal insulin in type 1 diabetes: ONWARDS 6
Associations between mean fasting glucose levels and adherence to app-based dose guidance for once-weekly insulin icodec in insulin-naive type 2 diabetes: post hoc analysis of ONWARDS 5
Ozempic® (once-weekly semaglutide 1.0 mg)
Kidney, cardiovascular and all-cause mortality outcomes of semaglutide with or without baseline MRA use in type 2 diabetes and CKD: a FLOW trial analysis
Non-product
Clinical implications of intentional weight loss in people living with T2D: A CPRD Aurum database study
Obesity
Wegovy® (once-weekly semaglutide 2.4 mg)
Is semaglutide as effective at reducing major cardiovascular events in the presence of impaired kidney function in people with overweight or obesity? A pre-specified analysis from the SELECT trial
Saxenda® (once-daily liraglutide 3.0 mg)
Liraglutide 3.0 mg for the treatment of obesity in children aged 6 to <12 years: results from the first randomised, phase 3 study
Oral amycretin
Safety, tolerability and weight reduction findings of oral amycretin: A novel amylin and glucagon-like peptide-1 receptor co-agonist, in a first-in-human study
CagriSema
CagriSema improves insulin sensitivity in diet-induced obese rats
CagriSema-driven weight loss in diet-induced obese rats depends on counter-regulation of weight loss associated reduction in energy expenditure
No clinically relevant QTc prolongation with cagrilintide: a thorough QT study in healthy participants
Brain circuitry activated by cagrilintide, semaglutide and CagriSema in mice
Digital Health
Multinational analysis of factors associated with missed bolus insulin injections using smart pen data
Improvement in time in range after smart insulin pen initiation in Austria
Regular at-home monitoring of stimulated dried blood spot C-peptide levels can detect changes in beta cell function early in individuals with recently diagnosed type 1 diabetes
Continuous glucose monitoring in first-degree relatives with stage 2 diabetes
About Awiqli® (once-weekly basal insulin icodec)
Awiqli® (once-weekly insulin icodec) is a novel once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. In the EU, Awiqli® is indicated for the treatment of diabetes mellitus in adults.
About Ozempic® (semaglutide 1.0 mg)
In the EU, Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.
About Wegovy® (semaglutide 2.4 mg)
In the EU, Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity), or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg.
About Saxenda® (liraglutide 3.0 mg)
In Europe, Saxenda® is indicated along with diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity), or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Saxenda® is also indicated for adolescents from 12 years of age with obesity (BMI of 30 kg/m2 or more) who weigh more than 60 kg.
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 69,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
Media:
Ambre James-Brown
+45 3079 9289
abmo@novonordisk.com Liz Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
Bagsværd, Denmark, 6 September 2024 - Novo Nordisk today announced the presentation of 21 abstracts (7 oral and 14 short oral presentations) at the upcoming 60th Annual Meeting of the European Association for the Study of Diabetes (EASD), which will take place from 9 to 13 September 2024 in Madrid, Spain.
In addition to the abstracts, data will also be presented in dedicated scientific symposia. These include results from the COMBINE clinical programme with IcoSema, a combination of once-weekly basal insulin icodec and once-weekly semaglutide, in people with type 2 diabetes, the FLOW trial evaluating semaglutide 1.0 mg on kidney outcomes in people with type 2 diabetes and chronic kidney disease, and amylin treatment for metabolic disease.
"Cardiometabolic conditions like diabetes, obesity, cardiovascular and kidney disease, all result from closely interlinked underlying risk factors and are among the most significant health challenges society faces today. Tailored treatment options that aim to holistically address these conditions are therefore needed," said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. "At EASD this year, we are showcasing new data from across our diabetes, obesity, cardiovascular and renal pipeline and portfolio, where we continue to push boundaries with the goal of advancing treatments in order to help more patients."
Summary of presentations
Accepted data at the 60th annual meeting of the EASD include the following oral and short oral presentations. Accepted abstracts include preliminary data that may be subject to change in final published manuscripts. Dates and times of the presentations and the abstracts can be found on the EASD website.
EASD scientific symposia
Amylin for treatment of metabolic diseases (10 September 2024; 17.15-18.15 CEST)
FLOW: the first dedicated kidney outcomes trial with a GLP-1 RA, semaglutide, in patients with T2D and CKD (11 September 2024; 09.00-10.30 CEST)
Taking a COMBINEd approach: insulin icodec and semaglutide (11 September 2024; 17.30-18.30 CEST)
EASD oral and short oral presentations
Diabetes
Awiqli® (once-weekly basal insulin icodec)
Impact of age on the efficacy and safety of once-weekly insulin icodec versus once-daily insulin in type 2 diabetes (ONWARDS 1-5)
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline sodium-glucose cotransporter-2 inhibitor use: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist use: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes by ethnicity and race: ONWARDS 1-5
Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: ONWARDS 1-5
No evidence of increased physical activity-related hypoglycaemia with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes: ONWARDS 1-5
No evidence of increased physical activity-related hypoglycaemia with once-weekly insulin icodec versus once-daily basal insulin in type 1 diabetes: ONWARDS 6
Associations between mean fasting glucose levels and adherence to app-based dose guidance for once-weekly insulin icodec in insulin-naive type 2 diabetes: post hoc analysis of ONWARDS 5
Ozempic® (once-weekly semaglutide 1.0 mg)
Kidney, cardiovascular and all-cause mortality outcomes of semaglutide with or without baseline MRA use in type 2 diabetes and CKD: a FLOW trial analysis
Non-product
Clinical implications of intentional weight loss in people living with T2D: A CPRD Aurum database study
Obesity
Wegovy® (once-weekly semaglutide 2.4 mg)
Is semaglutide as effective at reducing major cardiovascular events in the presence of impaired kidney function in people with overweight or obesity? A pre-specified analysis from the SELECT trial
Saxenda® (once-daily liraglutide 3.0 mg)
Liraglutide 3.0 mg for the treatment of obesity in children aged 6 to <12 years: results from the first randomised, phase 3 study
Oral amycretin
Safety, tolerability and weight reduction findings of oral amycretin: A novel amylin and glucagon-like peptide-1 receptor co-agonist, in a first-in-human study
CagriSema
CagriSema improves insulin sensitivity in diet-induced obese rats
CagriSema-driven weight loss in diet-induced obese rats depends on counter-regulation of weight loss associated reduction in energy expenditure
No clinically relevant QTc prolongation with cagrilintide: a thorough QT study in healthy participants
Brain circuitry activated by cagrilintide, semaglutide and CagriSema in mice
Digital Health
Multinational analysis of factors associated with missed bolus insulin injections using smart pen data
Improvement in time in range after smart insulin pen initiation in Austria
Regular at-home monitoring of stimulated dried blood spot C-peptide levels can detect changes in beta cell function early in individuals with recently diagnosed type 1 diabetes
Continuous glucose monitoring in first-degree relatives with stage 2 diabetes
About Awiqli® (once-weekly basal insulin icodec)
Awiqli® (once-weekly insulin icodec) is a novel once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. In the EU, Awiqli® is indicated for the treatment of diabetes mellitus in adults.
About Ozempic® (semaglutide 1.0 mg)
In the EU, Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.
About Wegovy® (semaglutide 2.4 mg)
In the EU, Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity), or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg.
About Saxenda® (liraglutide 3.0 mg)
In Europe, Saxenda® is indicated along with diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity), or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Saxenda® is also indicated for adolescents from 12 years of age with obesity (BMI of 30 kg/m2 or more) who weigh more than 60 kg.
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 69,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
Media:
Ambre James-Brown
+45 3079 9289
abmo@novonordisk.com Liz Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
