Preclinical Research
Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses
Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) (“Virpax”), a company specializing in developing non-addictive products for pain management, PTSD, central nervous system (CNS) disorders, and viral barrier indications, to conduct preclinical studies in support of their development of quaternary ammonium palmitoyl glycol chitosan (GCPQ, under the trade name of AnQlar™). AnQlar is a nanoparticle intended to help prevent the spread of negatively charged viruses such as COVID-19 and influenza via intranasal spray, and has been shown to inhibit the ability of the virus to replicate at non-toxic concentrations.
In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ preclinical site in Columbia, MO. A cardiovascular study was also completed at Altasciences’ preclinical facility in Scranton, PA.
Bioanalytical sample analysis for the GLP studies is currently ongoing. “We are very pleased to be working with Virpax again and are satisfied with the trajectory our studies have taken. The final step for this program will be a bioanalytical sample analysis. Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences.
Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. We look forward to further collaboration with Virpax in the near-future.”
Sheila Mathias PhD, Chief Scientific Officer, Virpax, also said of the project: “Our work with Altasciences over the last year has been both exceedingly productive and rewarding demonstrating tangible results, and the preclinical support provided has been vital in ensuring the progress of this project."
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 Virpax
Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™, a single injection liposomal bupivacaine formulation being developed to manage post-operative pain, and Envelta™, an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer.
Virpax is also using its intranasal molecular envelope technology (MET) to develop two other product candidates. PES200, is a product candidate being developed to manage PTSD, and NobrXiol™, a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD), for the management of rare pediatric epilepsy.
Having recently acquired global rights to NobrXiol, Virpax has competitive cooperative research and development agreements (CRADAs) for all three of its prescription drug candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD).
Virpax is currently seeking approval of two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis.
For more information, please visit virpaxpharma.com or follow on Twitter, LinkedIn, and YouTube.
Virpax Media Contact:
Robert Cavosi
RooneyPartners
+1 646 638-9891
rcavosi@rooneypartners.com
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
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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.
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