Clinical Trials
Think Ethnobridging Sooner!
Planning a Phase I clinical trial? Consider an ethnobridging strategy.
By conducting vital analyses on Asian participants during Phase I studies conducted in Western regions, you can significantly cut costs and shorten the NDA timeline. This strategy streamlines the approval process in Asian markets and addresses potential disparities in drug metabolism between Asian and non-Asian populations.
Here are some key resources for ethnobridging in Phase I clinical trials:
In this issue of The Altascientist, we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently.
In this complimentary webinar, Mel B. Affrime, PharmD, Executive Vice President, Translational Medicine, discusses how ethnic differences can impact the bioavailability of your drug candidate and how to design a multiregional clinical development program to hasten worldwide regulatory approval safely.
Speak with an expert today to discuss your next clinical program.
You may also be interested in the following webpages:
Ethnobridging Clinical Trials
Early Clinical Development Services — Phase I/II
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Say Goodbye to Clinical Trial Delays!
Your Passport to Success
At Altasciences, we understand the importance of streamlining your drug development process and ensuring the highest quality results. We provide a comprehensive, North American solution that significantly enhances the clinical trial phase, from design and conduct to compiling data for regulatory submission.
Here's why Altasciences is your ideal CRO partner:
- We conduct trials in both Canada and the U.S.
You can experience expedited timelines by conducting trials in Canada, giving you a competitive edge right from the start. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals. Discover more: An Overview of Health Canada's CTA Process
- We have optimized workflows for efficient bioanalytical sample processing.
Save time with our optimized workflows that ensure timely processing, transport, and analysis of your samples. Our co-located clinics and labs in both Canada and the U.S. work seamlessly to accelerate your data. Watch how: Accelerate Your Data With Our Canadian Co-located Clinic and Lab
- We can prevent repeated Phase I studies for drugs intended for the Asian market.
Speed up approval of your drug in Asian markets by conducting your trials at our clinical site in L.A., one of the most ethnically diverse regions in the U.S. Our expertise in ethnobridging trials can pave the way for your global market access. Learn more: Shortening Drug Development Timelines With Asian Ethnobridging Trials
- We have driving simulators on-site.
For CNS drugs that need assessment of their impact on driving ability, start your study faster and with lower costs thanks to our on-site driving simulators in Montréal. 13,000+ simulated drives completed to date! Learn how: Studying the Effects of Drugs on Driving
- We specialize in human abuse potential assessments.
Benefit from experience at our Kansas City clinical site—we have successfully conducted over 60 HAP studies, including for stimulants, opioids, and sedative-hypnotics. Read more: Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs
We offer specialized ophthalmology expertise.
Benefit from combined clinical and scientific expertise specific to ophthalmology and our co-located ophthalmic clinic. See how: Co-located Canadian Ophthalmology Center for All Your Early Phase Development Needs
Schedule a chat with our experts to learn more about how Altasciences can be your only North American clinical trial solution. Contact Us to get started.
[Video] Watch and Smile – Our Canadian Team in Action
Think Canada!
If you have yet to visit our Montréal clinical facility to learn about the advantages of conducting trials in Canada or had the pleasure of meeting the friendly, uniquely talented, and experienced team working on your studies, you will want to watch our latest video.
You may also be interested in the following:
• Webpage: Clinical Research Services
• Scientific Journal: The Advantages of Conducting Early Phase Clinical Research in Canada
• eBook: Altasciences' Facilities: Moving in Unison
Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials
September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.
Altasciences' Facilities: Moving in Unison
Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)
Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal.
The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. Single ascending doses (SAD) of CMX-2043 were administered by brief intravenous infusion to 40 male and female participants. Once completed, an additional 40 male and female participants were randomized and received multiple ascending doses (MAD) in the same manner, over five days. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.
“This Phase I trial demonstrates that CMX-2043 has the potential for an excellent safety profile when given intravenously over a wide range of doses”, explained Jerry O. Stern, MD, Chief Medical Officer for Ischemix. “There were no serious adverse events, and all treatment-emergent adverse events were mild and self-limiting. Importantly, the Principal Investigator determined that few adverse events were drug-related.”
There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. TBI is responsible for 60,000 deaths per year, and the cause of 80,000 cases of permanent disability.
“It was a pleasure collaborating as the Principal Investigator on this clinical study. We are extremely pleased with the outcome of the CMX-2043 Phase I trial. Having personally witnessed first-hand the outcome that TBI can have on the lives of many people, we hope that the work we are doing with Ischemix will continue to progress. If successful, this treatment could have a tremendous positive impact on the quality of life for TBI patients. That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We wish the team at Ischemix continued success on the next Phase of clinical research.”
Additionally, Co-chief Operating Officer, Marie-Hélène Raigneau, said of the study: “Our goal at Altasciences is to help companies like Ischemix expedite the drug development process without compromising on quality or safety. We are proud to support Ischemix in advancing this vital new therapy.”
Ischemix expects to complete all of the work required for a Phase II trial of CMX-2043 in acute TBI by the end of 2023, and plans to request a pre-IND meeting with FDA for early Q1 2024.
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 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, 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.
About Ischemix, Inc.
Ischemix Inc. is a privately held drug development company based in Grafton, MA. Learn more about the company at www.ischemix.com.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Comprehensive Solutions for Your First-in-Human Trials
A Partner You Can Trust
Altasciences has decades of experience designing, conducting, and reporting on first-in-human (FIH) clinical trials. Simple or complex, we have the expertise, purpose-built Phase I facilities, and seamless processes to deliver quality with speed and ease. Benefit from our customized approach, including clinical pharmacology units and integrated, state-of-the-art bioanalytical laboratories in the U.S. and Canada, along with the full range of complementary services.
Have a look at these resources to learn more:
Maximizing Drug Formulation for First-in-Human Trials
Planning Your First-in-Human Trial
Have questions? Contact our experts today.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
You have questions; we have answers.
| |||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||
To You, With Science - Our Latest Audiobook Releases
Listen to the Latest Audiobook Releases of The Altascientist
Delve deeper into the critical processes behind early phase drug development with audio versions of The Altascientist, written by our experts with you in mind:
 Issue 31 — The Advantages of Conducting Early Phase Clinical Research in Canada |  Issue 32 — A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies |
 Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity |  In Case You Missed It: |
[NEW PODCAST] Exploring the FDA's Draft Guidance on Psychedelic Drug Research
Unlocking New Horizons
The FDA recently published a first-ever draft guidance on clinical development requirements for psychedelic drugs.
Join Altasciences’ panel of experts as they provide an in-depth review of the guidance and valuable insights into the areas where further methodological adaptations to study designs may be necessary. These adaptations play a pivotal role in accurately assessing the safety, pharmacology, and efficacy of groundbreaking psychedelic compounds developed for specific medical applications.
You may also be interested in the following:
• Webpage: CNS Drug Development Solutions
• Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
• Webinar: Practical Approaches to Conducting Early Clinical Trials with Psychedelics