Industry Dynamics
Industry Dynamics
Semaglutide Treatment for Alzheimer's Disease!Novand Nod directly initiated the 3,700 human phase IIIa trial
On December 16, Novand Nod announced that they would launch a phase III research program on oral Semaglutide for Alzheimer's disease.Norand Nordisk's decision was made after evaluating preclinical animal model data, real-world study data and post-hoc analysis of large cardiovascular outcomes studies, while also discussed with regulators.
Data from animal model studies suggest a critical role for GLP-1 in the treatment of Alzheimer's, including improved memory function and reducing the accumulation of phosphorylated tau proteins, and Semaglutide has also been shown to mitigate neuroinflammation with potential effects on cognitive and physical function.There is also a potential link between GLP-1 treatment and the reduced risk of dementia, based on the real-world research evidence of the US Truven claims database and the US FDA FAERS database registered in Denmark.
In addition, Novand Nord conducted a post-hoc analysis of trial data from three large cardiovascular outcomes studies of LEADER,SUSTAIN 6 and PIONEER 6, with a median follow-up time of 15,820 patients with type 2 diabetes and found 47 with dementia (early mild Alzheimer's disease), 32 using placebo and 15 with GLP-1 medication (raluptide or Semaglutide).Statistically, the incidence of dementia decreased significantly by 53%, thus providing evidence for GLP-1 for dementia.
As planned, Norand Norde will directly initiate a key phase IIIa study involving about 3700 patients with early Alzheimer's disease, beginning patient recruitment at 2021H1, primarily assessing differences in efficacy and safety of oral Semaglutide (14mg, 1 daily) compared to placebo, and administration is expected to last approximately 2 years.
Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk, said, " We are eager to address highly unmet medical needs in severe chronic diseases, so we are pleased to be able to launch Semaglutide Phase 3 development for treating Alzheimer's disease.Alzheimer's has been an area of widely watched research over the past few decades, but unfortunately there have been no major medical breakthroughs in the field.With the growing evidence to meet medical needs and the potential role of GLP-1 in the treatment of Alzheimer's, we will explore the therapeutic benefit of oral Semaglutide for early Alzheimer's disease.”
Alzheimer's disease is one of the increasingly prominent public health problems, having serious adverse effects on patients and their families, and leading to an increasing global socioeconomic burden.An estimated 70 million ~ of 100 million people worldwide have early Alzheimer's disease (mild cognitive impairment and mild dementia).
Oral Semaglutide (7mg and 14mg) has been approved in the United States, Europe and Japan to assist diet and exercise to improve blood glucose control in patients with type 2 diabetes.It showed excellent safety and tolerability of patients in 10 clinical trials that designed 9,543 patients, with the most common adverse events being mainly transient mild nausea.
On December 4, Novo Nordisk just filed a marketing application to FDA for a weekly subcutaneous Semaglutide2.4mg injection, assisting a low-fat diet and enhanced exercise for chronic weight management in obese (BMI≥ 30kg/m2) or overweight (BMI≥ 27kg/m2) adults with at least one weight-related comorbidities.
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