Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides
Current Strategies for Using Commercial LBA Kit in Regulated Bioanalysis
Altasciences Completes Clinical Portion of Alzamend Neuro's Phase IIa Multiple Ascending Dose Clinical Trial for Treatment of Dementia Related to Alzheimer's
Laval, Québec, April 18, 2023 – Altasciences is proud to support Alzamend Neuro, Inc. (Alzamend) in advancing a novel treatment for dementia related to Alzheimer’s disease (Alzheimer’s). In addition to having conducted Alzamend’s Phase IIa multiple ascending dose (MAD) clinical trial in healthy subjects, Altasciences is continuing to provide clinical monitoring, project management, biostatistics, pharmacokinetics (PK), bioanalysis, and medical writing solutions as the product candidate is evaluated in Alzheimer’s patients.
The purpose of the MAD study conducted at Altasciences’ Montréal clinical pharmacology unit, was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions; to determine the maximum tolerated dose in healthy young and elderly study participants; and to allow Alzamend to proceed to the next step: dosing in planned subsequent Phase IIa clinical trials involving Alzheimer’s, bipolar disorder, major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) subjects.
“Our Phase I study was successfully conducted with Altasciences and we are excited to continue this partnership with our Phase IIa MAD study,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We strongly believe that AL001’s patented ionic cocrystal technology may constitute a means of treating over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD, and PTSD. We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic.”
The clinical and PK data generated during the clinical portion of the MAD study are undergoing evaluation by Altasciences to characterize the safety and drug exposure in healthy subjects, as well as Alzheimer’s patients.
“Altasciences’ mission is to help sponsors bring promising novel treatments, like AL001, to the people who need them, faster,” says Marie-Hélène Raigneau, Co-chief Operating Officer. “Our team takes immense pride in the role we play to help improve lives through drug development, and is delighted to continue our valued partnership with Alzamend.”
Altasciences has decades of experience with early phase drug development, supporting sponsors with an end-to-end solution, from preclinical studies to clinical proof of concept, and beyond.
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 Alzamend Neuro
Alzamend is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, major depressive disorder and post-traumatic stress disorder. Their mission is to rapidly develop and market safe and effective treatments. Their current pipeline consists of two novel therapeutic drug candidates, AL001, a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate; and ALZN002, a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses. To learn more about Alzamend, visit alzamend.com.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
In Issue 33 of The Altascientist, we explore how a comprehensive, end-to-end integrated approach to drug development for central nervous system (CNS) therapeutics can take you seamlessly from lead candidate selection to market.
Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.
With detailed case studies, study considerations, and more, this Issue covers:
- preclinical safety and toxicity testing,
- formulation and manufacturing,
- early-phase clinical trials, and
- bioanalysis.
the cns drug development landscape
The different parts of the nervous system, including the brain and spinal cord (i.e., central nervous system – CNS) and the peripheral nervous system, are important drug targets for many serious diseases affecting human health. As the body’s processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors.
According to Fortune Business Insights, the global CNS market is projected to grow from $89.02 billion in 2021 to $166.53 billion in 2028, at a compound annual growth rate (CAGR) of 9.4%. This growth is driven primarily by the rising demand for age-related neurodegenerative treatments due to the increasing global population over the age of 65, the growing potential of psychedelic therapies in treating conditions like PTSD and psychosis, and CNS-active drugs proving increasingly effective across various areas, such as acute and chronic pain, brain diseases, and autoimmune disorders.
“The successful delivery of drugs targeting the treatment of CNS conditions is challenged by the blood-brain barrier (BBB) and blood-cerebrospinal fluid barrier (BSCFB), which protect the CNS from intrusion by harmful substances. Large molecules are less able to penetrate the blood/brain barrier to deliver therapeutic results and thus most CNS-active drugs are small molecules.” — The Altascientist, Issue 33, pg. 2.
SPECIALIZED ASSESSMENTS AND STUDIES
Unsurprisingly, drugs working on the CNS are subject to stringent regulatory requirements, and specialized safety assessments are often mandated. To confirm CNS activity without safety concerns, dedicated nonclinical and early-phase clinical studies, with relevant endpoints and biomarkers and supporting bioanalysis, are needed, and drug manufacturing must be carefully managed via rigorous handling and production processes.
“Specialized assessments in nerve conduction are sometimes performed in CNS drug development, depending on the specifics of the new molecular entities. These key assays, performed in NHPs, can be included in preclinical safety and toxicology programs to assess the peripheral neuropathy (PN) liability of a new drug.” — The Altascientist, Issue 33 pg. 5.
The many advancements in developing CNS-active drugs have been hampered by higher failure rates compared to drug discovery in most other therapeutic domains. Identifying CNS experts with a well-established record of conducting rigorous, high-quality research can assure the effective management of challenges and reduce the risks of delaying or failing to advance promising drug candidates.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Four Key Steps to Optimizing a Large Molecule Bioanalytical Program
Biologics are large, complex molecules that can undergo structural changes during the manufacturing process, storage, or administration to patients. This means bioanalysis of biologics is a critical aspect of the drug development process, and one that requires sensitivity, specificity, and selectivity.
Get Ahead of the Game with Flexible Phase 1 Study Timing
Development of a Flow Cytometry Phospho-STAT5 Assay in Nonhuman Primate T Cells
Strategies for Reducing the Number of Animals in Toxicity Testing: A Comparative Approach for Rodent and Large Animal Studies
Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors: Historical Data Review to Characterize Common Challenges and Identify Opportunities for Refinement
Comparison of Toxicology Assessment Baseline Data Collected Using Two Restraint Methods in Nonhuman Primates: Restraint Chair/Pole and Collar vs. Procedure Cage