Sugar-lowering drugs to treat Alzheimer's disease (AD)! Novo Nord launches a high-dose oral semaglutide (Smeglutide) Phase 3 clinical project!

December 18, 2020 // -- Novo Nordisk recently announced its decision to enter Phase 3 clinical development to evaluate the use of 14mg oral semaglutide (Chinese generic name: Smegropeptide) for the treatment of Alzheimer's disease (AD).
14mg oral semaglutide is a daily oral preparation for the long-lasting GLP-1 similar semaglutide.
decision was made after an assessment of GLP-1 data from preclinical models, real-world evidence studies, post-mortem analysis of large cardiovascular outcome trials, and discussions with regulators.
and Nord plan to launch a key Phase 3a clinical project in a group of about 3,700 early AD patients.
the project is scheduled to start in the first half of 2021 to assess the effectiveness and safety of the daily oral semaglutide in relation to placebos.
trial of the project, the expected main treatment period is about 2 years.
Ads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer,
Alzheimer's Disease-AD (photo: tecake.in) and Nord, said, "We are eager to address the highly unseconomic medical needs of severe chronic diseases, so we are pleased to launch phase 3 clinical development of Semagidelut in Alzheimer's disease.
alzheimer's disease has been an area of extensive research for decades, and unfortunately there have been no major medical breakthroughs.
we will look at the benefits of oral semaglutide in treating early-stage Alzheimer's disease due to the growing unseconded medical needs and growing evidence of the potential therapeutic effects of GLP-1.
" Alzheimer's disease (AD) is a rapidly growing public health problem with significant and harmful consequences for affected people and their families, and has led to significant and growing global socio-economic impacts.
an estimated 700-100 million people worldwide suffer from early-stage Alzheimer's disease (mild cognitive impairment and mild dementia).
on preclinical models, real-world evidence studies and post-mortem analysis: Animal studies highlight the key role of AD-related GLP-1, including improving memory function and reducing the accumulation of phosphate τ phosphate.
has been shown to reduce neuro-inflammation, which can affect cognition and function.
addition, real evidence from two national registries in Denmark, the U.S. Truven Claims Database and the FDA FAERS Database, supports a potential link between the reduced risk of dementia after GLP-1 treatment.
, in an ex post-mortem analysis of data from three large cardiovascular outcome trials (LEADER, SUSTAIN 6 and PINER 6) conducted by Noor and Nord, a total of 47 people were identified as having dementia, 32 of whom took placebos and 15 took GLP-1 (liraglutide or semaglutide).
in favor of GLP-1, showing a statistically significant 53% reduction in the risk of dementia.
About Semaglutide (Smeglutide): Semaglutide (Chinese generic name: Smeglutide) is a human glutamaglytin-like peptide-1 (GLP-1) similar, with glucose concentration dependence mechanism to promote insulin secretion and inhibit glucoglycogen secretion, can make type 2 diabetes patients blood sugar levels significantly improved, and low blood sugar risk is low.
addition, semaglutide can induce weight loss by reducing appetite and food intake.
addition, semaglutide significantly reduces the risk of major cardiovascular events (MACEs) in people with type 2 diabetes.
currently, Novo Nord has developed injection preparations (Ozempic) and oral preparations (Rybelsus) for semaglutide:-Ozempic (semaglutide, injection preparation): a weekly sub-cortective injection preparation (0.5 mg or 1 mg) for: (1) as an aid to dietary adjustment and exercise to improve blood sugar control in adults with type 2 diabetes, (2) for adults with type 2 diabetes with cardiovascular disease (CVD), reducing the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal heart attack, non-fatal stroke).
first FDA approval in December 2017 and is now available in many countries and regions around the world.
The drug's second allergy was approved by the FDA in January 2020, and data from the Cardiovascular Outcome Trial (CVOT) SUSTAIN 6 showed that Ozempic statistically reduced the risk of COMPOUND compound endpoints by 26% when combined with standard care for cardiovascular (CV) patients with type 2 diabetes compared to placebo.
- Rybelsus (semaglutide, oral tablet): is a daily oral preparation containing the absorbent exonerate SNAC, which is suitable for improving blood sugar control in adults with type 2 diabetes as a dietary adjustment and exercise and ancillary drug.
Rybelsus is the world's first and only oral version of GLP-1 permitation, taking the drug once a day in 2 doses: 7mg and 14mg.
In the U.S., Rybelsus' label was updated in January 2020 to include additional information about PIONER 6 CVOT, a trial conducted in patients with type 2 diabetes at high risk of CV, showing that Rybelsus reached the primary endpoint of compound MACE endpoint non-poor performance when combined with placebo, demonstrating CV safety.
study, the proportion of patients who experienced MACE at least once was 3.8 percent in the Rybelsus group and 4.8 percent in the placebo group.
, Noor and Nord are also working on a weekly semaglutide 2.4 mg subsulpheric injection as a treatment for obesity in adults.
can induce weight loss by reducing hunger and satiety, helping people eat less and eat fewer calories.
Earlier this month, No. > submitted to the FDA a new drug application (NDA) for semaglutide 2.4 mg subderpic injection preparation, a weekly glutacone-like peptide-1 (GLP-1) similar to GLP-1 for long-term weight management.
noted that Noor and Nord also submitted a Priority Review Voucher (PRV) to speed up the NDA review process, which shortens the NDA review cycle from the standard 10 months to six months.
the 2.4mg subsulphic injection preparation application for the following: as a low-calorie diet and exercise-enhancing aids, used to treat obese (BMI≥30kg/m2) or overweight (BMI≥27kg/m2) and accompanied by at least one type of weight-related combination in adult patients.
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