Semaglutide(Hybio)

MetP Pharma has announced its preclinical research results that strongly support the further development of semaglutide in an oleogel formulation using the BrainDos drug delivery technology. Semaglutide, the active ingredient of Ozempic and Wegovy, is an antidiabetic medication used for the treatment of type 2 diabetes as well as an anti-obesity medication used for long-term weight management. It is a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1-RA) that is currently administered through subcutaneous injection using pens. GLP-1 receptors are found on beta cells of the pancreas and on neurons of the brain. There, signal chains are activated that suppress the feeling of hunger and increase the feeling of satiety. It is proven that GLP-1 RAs can send information to the brain via neural and humoral pathways. Preclinical studies in Cultured Human Airway Epithelial Cells (Calu-3) conducted at MetP Pharma AG demonstrate that the semaglutide oleogel in the BrainDos formulation leads to a 10-fold increase in tyrosine hydroxylase (TH) expression, compared to only a 2-fold increase of the aqueous semaglutide solution as used for example in pens. As obesity leads to a reduction in tyrosine hydroxylase (TH) levels (1) an increase in TH levels is a suitable biomarker for drug delivery. The results also demonstrate a significantly higher TH response at 4 h than at 24 h post treatment but the TH level at 24 h is still about 3-fold higher than the untreated control demonstrating consistent activity. The semaglutide concentration in both the oleogel formulation and the aqueous solution was 10 nM. Dr. Claudia Mattern, Chief Scientific Officer at MetP Pharma said, “The preclinical studies clearly show that the oleogel formulation with BrainDos increases the delivery of semaglutide into cells. This makes BrainDos suitable for re-formulating active ingredients with expiring patents and re-patenting them using a new, innovative application method. It is important to understand that BrainDos is an innovative nose-to-brain drug delivery technology that in no way is comparable to traditional nasal sprays.” A nasal application of semaglutide could have several advantages compared to pens such as non-invasiveness, fast and easy administration, painless application for patients with needle phobia, fewer adverse events through reduced systemic exposure of the drug, and much lower costs per application than pens. In addition, there is the ability for direct CNS delivery using BrainDos potentially resulting in a higher bioavailability.

The US Food and Drug Administration (FDA) has granted approval for a groundbreaking new indication for Wegovy (semaglutide) injection, a medication aimed at reducing the risk of cardiovascular death, heart attack, and stroke in adults grappling with both cardiovascular disease and either obesity or overweight. "Today, Wegovy becomes the pioneer in weight loss medication to secure approval for mitigating life-threatening cardiovascular events among adults contending with cardiovascular disease and either obesity or overweight," stated Dr. John Sharretts, Director of the Division of Diabetes, Lipid Disorders, and Obesity within the FDA’s Center for Drug Evaluation and Research. "This demographic faces heightened risks of cardiovascular complications, making the availability of a treatment option proven to alleviate such risks a pivotal stride forward for public health." Obesity and overweight afflict approximately 70 percent of American adults, posing grave health hazards that elevate the likelihood of premature mortality and a spectrum of health ailments, including heart attack and stroke. Wegovy, housing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, underscores a crucial advancement in pharmacological intervention. However, it is cautioned that Wegovy should not be used concurrently with other semaglutide-containing products or other GLP-1 receptor agonists. The efficacy and safety of Wegovy for its new indication underwent rigorous evaluation in a multi-national, multi-center, placebo-controlled double-blind trial encompassing over 17,600 participants. The study revealed a notable reduction in the incidence of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke) among participants receiving Wegovy compared to those receiving placebo. Despite its benefits, Wegovy carries certain warnings and precautions, including the risk of thyroid C-cell tumors, pancreatitis, gallbladder problems, low blood sugar, acute kidney injury, and allergic reactions, among others. Patients with a history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 should refrain from using Wegovy. Common side effects associated with Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, and others. Notably, Wegovy received Priority Review designation from the FDA, underscoring its significance in addressing unmet medical needs. The approval for Wegovy's new indication was granted to Novo Nordisk A/S, a testament to the pharmaceutical company's commitment to advancing therapeutic interventions in the realm of cardiovascular health and obesity management. Wegovy, already endorsed for weight reduction and maintenance in certain adults and children grappling with obesity or overweight, further solidifies its position as a versatile tool in the arsenal against these pervasive health challenges.