Clinical Trials
Altasciences Supports Metsera in Their Early-Stage Clinical Trials for Obesity
Laval, Québec, November 21, 2024—Altasciences is proud to have supported Metsera, Inc., a clinical stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, on its nonclinical and early-stage clinical trials. This support includes a recent Phase I/II trial of MET-097i, an ultra-long-acting injectable, fully biased GLP-1 receptor agonist.
In September, Metsera reported positive topline results from the clinical trial conducted at Altasciences’ facility, in which MET-097i demonstrated a 7.5% reduction in body weight from baseline at day 36 (one week after the final dose) and a 380-hour half-life. This work enabled Metsera to recently initiate a randomized 16-week Phase II trial of MET-097i.
In addition to clinical conduct, Altasciences supported Metsera with its proactive drug development solution, including nonclinical, bioanalysis, CRO and program management services for several additional therapeutic candidates. Over the past six months, Altasciences has completed nonclinical work for MET-233i, an ultra-long-acting injectable amylin analog, as well as MET-002, an oral GLP-1 receptor agonist peptide, which has proven instrumental in allowing Metsera to begin clinical trials for both programs this year.
"Congratulations to Metsera on reaching this significant milestone in the development of MET-097i," said Ingrid Holmes, Vice President of Global Clinical Operations at Altasciences. "Metsera is a highly valued partner of Altasciences, and we are proud to have contributed to this program aimed at helping individuals struggling with obesity-related illnesses."
Obesity impacts millions of people worldwide and is a driver of serious health risks, including type 2 diabetes, heart disease, and certain cancers. Innovative treatments, like MET-097i, could offer potential new treatment options for those affected by this complex condition.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
jcabana@altasciences.com
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ISSUE NO. 42 — Managing The Complexities of Glucagon-Like Peptide-1 Receptor Agonist Drug Development
Current and future development of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or simply GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.
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Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.
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This issue also covers:
• classes of immunomodulators, including monoclonal antibodies, CAR-T cells, and vaccines;
• immunotherapy trials, focusing on complex study designs and diverse patient populations; and
• bioanalytical methods and assays, including pharmacokinetics and anti-drug antibodies (ADA).
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