May 2024: The Ozempic Craze: In the Perspective of Antibody Drugs
Biointron2024-05-30Read time: 3 mins
Ozempic, a brand name for the drug semaglutide, was originally developed to manage type 2 diabetes by improving blood sugar control. As a GLP-1 receptor agonist, it mimics a hormone that regulates glucose metabolism and appetite. Beyond its success in diabetes treatment, Ozempic has garnered significant attention for its weight loss effects, becoming a popular off-label prescription for obesity management. This newfound fame has sparked a broader interest in weight loss medications, highlighting the potential of advanced treatments, including antibody drugs, in combating obesity.
This month, several pharmaceutical companies have announced news on the development of antibody drugs to treat obesity, including:
May 3: Amgen announced positive early results from a study of MariTide (maridebart cafraglutide), an antibody-peptide conjugate obesity drug. The drug is made up of a fully human monoclonal anti-human GIPR antagonist antibody conjugated to two GLP-1 analogue agonist peptides using amino acid linkers.
Structure of AMG 133 (MariTide). DOI: 10.1038/s42255-023-00966-w
May 16: Roche's Phase 1 success for the GLP-1/GIP agonist CT-388, which is expected to be combined with GYM329 (RO7204239), a humanized anti-myostatin antibody. RO7204239 is being researched for its potential to strengthen the muscles of spinal muscular atrophy patients. By combining RO7204239 with CT-388, weight loss may be achieved without muscle loss.
Image credit: Roche
May 22: AstraZeneca has committed $80M to SixPeaks Bio for buyout option, if their bispecific antibody proves successful. The drug targets activin type IIA and IIB receptors, which are responsible for regulating muscle mass. Similar to Roche’s potential combination therapy, this bsAb is expected to overcome the common side effect of muscle loss that results from GLP-1 agonists.
Relative proportions of fat mass and lean body/fat-free mass within total weight loss elicited by GLP-1 receptor agonist therapy. DOI: 10.3803/EnM.2019.34.3.247
Meanwhile, a recent review by Melson et al. described bimagrumab, a human monoclonal antibody that stimulates skeletal muscle growth by blocking the activin type II receptor (ActRII). Currently undergoing Phase 2 trials, bimagrumab was originally developed by Novartis, but the drug has switched hands to Versanis, which was subsequently acquired by Eli Lilly. It has the potential of becoming an attractive treatment option for sarcopenic obesity.
This report aims to explore the events and trends of the biopharmaceutical industry in Q2 (April, May, June). Besides crovalimab and Vyloy, two more novel antibody drugs have been approved this year
These past few weeks, several antibody drug startups have progressed from the pre-seed stage to final funding rounds. In the pre-seed stage, the focus is on early research, often funded by founders, grants, or angel investors. As the company progresses to the seed stage, it seeks additional funding to validate its scientific concept and develop initial prototypes, attracting early-stage venture capital.
In August, the US FDA approved Galderma’s Nemluvio (nemolizumab) for adult patients living with prurigo nodularis (PN). Nemluvio is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in (PN). Prurigo nodularis is a chronic skin condition that affects approximately 181,000 patients in the United States
Anti-drug antibodies (ADAs) are immune system proteins that can develop in response to therapeutic drugs, particularly biologics like monoclonal antibodies. These biopharmaceuticals have significantly advanced therapies for cancer and autoimmune diseases, but their long-term use can elicit immunogenicity due to repeated administration. The host immune system may recognize epitopes in the biologic drug as foreign, triggering the production of ADAs. This can lead to the formation of drug–ADA immune complexes, which accelerate drug clearance and potentially neutralize the drug's efficacy.
