BioSpace: Altasciences Completes Phase I Study on Gimsilumab for ARDS in COVID-19
Altasciences Completes Phase I Study on Gimsilumab for ARDS in COVID-19
Laval, Quebec, March 27, 2020 – Altasciences has completed a Phase I study for the development of gimsilumab, a fully human monoclonal antibody that targets granulocyte-macrophage colony stimulating factor (GM-CSF), found to be up-regulated in SARS CoV-2 in patients with or at risk of developing acute respiratory distress syndrome (ARDS).
Roivant Sciences recently announced “they will prioritize trials of gimsilumab in patients with COVID-19 instead of a Phase 2 trial in a separate disease area which had been previously planned. Clinical trials of gimsilumab patients with COVID-19 will commence upon approval by relevant regulatory authorities.” Gimsilumab treatment has been associated with a favorable safety and tolerability profile to date.
Emerging clinical evidence in COVID-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS. ARDS is a serious complication of COVID-19 which necessitates hospitalization and mechanical ventilation or other life support measures.
“We are proud to have collaborated with Roivant Sciences on this important development, which may help ease the suffering of patients afflicted by COVID-19, as well as other ARDS patients in need of therapy” says Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.
“The team at Altasciences is proud to contribute in developing potentially lifesaving therapies to combat COVID-19. We are experiencing unprecedented times and it is humbling to see the research community come together to make a difference,” says Chris Perkin, CEO at Altasciences.
For over 25 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, and data management, all customizable to specific sponsor requirements.
Read Roivant Sciences’ announcement here.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Bioanalytical Project Management — a Critical Function Adapted to the Study Type(s) of Your Drug Development Program
The objective of quantitative bioanalysis is to provide precise and accurate sample analysis results within the acceptable tolerance (variability), in line with the study scope, so that sponsors can make appropriate go/no-go decisions. For proactive and efficient study progression, stakeholders must fully understand the operational, logistical, technical, and scientific considerations for the bioanalytical phase of various study types within a drug development program. Webinar participants will receive insight on this framework and the relevant critical control points.
Amphetamine to Zolpidem: Navigating the ABCs of Early Phase CNS Drug and Cannabinoid Development
CNS drug development continues to evolve with changing regulations, particularly in light of prescription drug abuse and risk/benefit optimization. The uncertainty with regulations around emerging therapeutics, including cannabinoids, adds to the confusion. Navigating a successful regulatory and commercial pathway for CNS drugs can pose challenges and delays when requirements are not met. In addition to NDA-enabling phase I studies, specialty studies may be required to further evaluate your risk/benefit profile and support a drug scheduling recommendation.
SOT Virtual Poster Session
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Strategic Considerations for a Successful CNS Clinical Development Pathway
Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued. Evaluation of CNS effects in Phase I studies can be very helpful in determining if dedicated driving simulator, abuse potential, and dependence studies are needed.
Altasciences and Amador Bioscience Announce Strategic Collaboration
Laval, Quebec, March 17, 2020 – Altasciences, a CRO in the U.S. and Canada specializing in a flexible, innovative approach to comprehensive early stage drug development, announced today that they have entered into an agreement with Amador Bioscience, a translational and consulting clinical research organization located in China and the U.S. This partnership aims to expand world-class capabilities and resources to promote drug development in China and North America.
“We are excited to collaborate with Amador Bioscience’s dedicated team of diverse experts, particularly in support of China’s fast-growing and innovative biotech industry,” stated Steve Mason, Executive Vice President, Altasciences.
Altasciences and Amador Bioscience will collaborate on IND-enabling preclinical studies, design and conduct of early-stage clinical programs, including first-in-human and proof-of-concept trials, as well as provide end-to-end solutions, such as laboratory services, to transpacific drug development programs.
“We are pleased to be partnering with Altasciences, offering our clients access to world-class preclinical and clinical facilities, personalized services, and 25 years’ expertise in conducting successful clinical trials,” said Xiaomin Chen, General Manager, Amador Bioscience. “Our synergistic and effective collaboration will surely expedite the development of novel therapeutics,” added Mrs. Chen.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 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, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. Altasciences has strategically placed facilities in the U.S. (Seattle and Kansas City) and Canada (Montreal and Laval).
About Amador Bioscience
Amador Bioscience provides global-standard laboratory, clinical research, strategy consulting and regulatory filing services to leading biopharmaceutical companies. The laboratory services focus on bioanalysis, biomarkers and immunogenicity assessment. Amador’s clinical research unit specializes in innovative clinical development strategy, protocol design, study initiation and monitoring of clinical studies in China and the U.S. In addition to the R&D strategy and regulatory pathway, Amador’s consulting services perform global-standard data analysis and generate submission-ready study reports. Amador has successfully supported CTD filings in China and U.S. Amador Bioscience operates in the U.S. (San Francisco Bay Area, Virginia) and China (Shanghai-Hanghzou and Beijing).