Clinical Trials
GLP-1 RA: Rapid Clinical Phase I Study Execution
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 amylin analog, 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, 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
Altasciences’ Commitment to Bioanalytical Excellence
Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services
We have been your trusted drug development research partner for over 30 years. We are committed to providing world-class bioanalytical services in support of the preclinical and clinical studies conducted at our cutting-edge facilities, as well as extensive standalone solutions to meet your diverse needs. Our flexible bioanalytical services from discovery to Phase IV empower our clients across every phase of research.
We recently launched the Unveiling the Invisible video campaign to showcase how our bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of your innovative therapies.
RELATED RESOURCES
Our bioanalytical team excels in comprehensive bioanalytical services, including assay and method development, molecular biology, mass spectrometry, ligand binding assays, immunogenicity testing, biomarker analysis, flow cytometry services, and more, to support your journey from discovery through Phase IV.
Below are some resources that highlight our extensive knowledge, and wealth of bioanalytical experience.
- The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials—Sophisticated Bioanalytical Approaches to Support Complex Modalities
- eBook: Key Considerations for Nonclinical AAV Gene Therapy Development
- eBook: Key Biomarkers of Immunomodulation
- Scientific Research Article: A Novel Hybridization LC-MS/MS Methodology for Quantification of siRNA
- Scientific Research Article: A Validated Capillary Microsampling LC-MS Method for Quantification of ASOs in Mouse Serum
- Scientific Research Article: Microsampling in Pediatric Studies
Discover the Dynamic Landscape of GLP-1 Drug Development
In this issue of The Altascientist, we explore the current and future development of GLP-1 receptor agonists (GLP-1 RAs), and the complexities involved in the early phases.
Topics covered include preclinical models, bioanalytical assays, clinical study design, manufacturing, and the expanding applications of GLP-1 drugs in treating various health conditions. Exclusive case studies are also presented.
Questions about your drug development program? Speak with one of our experts.
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In this new video, our clinical and manufacturing experts share how their teams collaborate and tailor solutions to meet your unique needs. They highlight real examples of going above and beyond by implementing innovative strategies to ensure your projects stay on track.
Looking for a more seamless drug development and manufacturing experience? Speak with one of our experts today.
Related resources that may interest you:
- Video: Nine Strategic Locations to Accelerate Study Timelines
- eBook: Maximizing Drug Formulation for First-in-Human Trials
- Webpage: Pharmaceutical Contract Manufacturing Services
- Podcast: Key Considerations as You Move From Discovery to Preclinical to Clinical
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Essential Guide for Analytical Testing
Fundamental Techniques for Optimal Bioavailability
Analytical testing of active pharmaceutical ingredients (APIs) is critical to ensuring their proper absorption and therapeutic effect. This document examines various analytical techniques that support pharmaceutical product development, with a focus on bioavailability. Methods for API characterization, solubility and dissolution testing, and formulation approaches to maximize bioavailability are discussed.
Altasciences provides contract HPLC/UPLC method development and validation, stability testing, as well as testing of raw materials, in-process, and finished products for your drug development programs. We take pride in developing, qualifying, and validating robust and rugged analytical procedures to ensure the quality of your products and meet the requirements of regulatory agencies worldwide.
Discover our comprehensive suite of drug development and manufacturing services.
Related resources that may interest you:
- Podcast: Ensuring the Successful Manufacturing of Your Clinical Trial Supply
- eBook: Nanomilling for Enhanced Solubility and Bioavailability
- Infographic: Choosing the Optimal Dosage Form for Your Molecule
Accelerated Study Timelines, Less Logistical Hurdles
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From preclinical studies to clinical trials, and from regulatory submissions to tackling operational challenges, we are dedicated to safely accelerating your journey from lead candidate selection to proof of concept and beyond using a seamless and integrated approach to drug development.
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