Camargo client Incannex Healthcare seeks expedited pre-IND meeting, Emergency Use Authorization for anti-inflammatory COVID-19 treatmentPosted Dec 01, 2020
CINCINNATI /PRNewswire/ – Clinical-stage cannabinoid development company Incannex Healthcare Limited (ASX: IHL) has announced its plans to request an expedited pre-IND meeting for its anti-inflammatory IHL-675 and to pursue an FDA Emergency Use Authorization (EUA) for the treatment of patients suffering from COVID-19. Incannex will partner with Camargo Pharmaceutical Services, LLC, regulatory experts in EUAs and other expedited pathways, to explore the fastest pathway for authorization of its product.
Incannex has received positive results from Eurofins (Taiwan) regarding the anti-inflammatory potency and synergistic activity of the fixed-dose combination of hydroxychloroquine and cannabidiol in nonclinical studies. The product is intended to treat patients with sepsis-associated acute respiratory distress syndrome (SAARDS) caused by COVID-19.
Camargo will assist Incannex in developing the nonclinical, clinical, pharmacological and biopharmaceutical strategy to be proposed to FDA. Incannex anticipates it will be granted an expedited pre-IND, in which Camargo will report the nonclinical results and request agreement on the future clinical development plans for an EUA.
“We are thrilled to partner with Incannex in these next steps as it fights the COVID-19 pandemic,” Mary Liz James, Vice President of Global Life Science Solutions, said. “As the number of people affected by the virus continues to grow, we are proud to support sponsors like Incannex who are working hard to identify an effective treatment for patients.”
Camargo is a leading global strategy, regulatory and development partner for emerging to mid-tier biopharma companies. Camargo specializes in complex development programs where no playbook exists, with integrated solutions to reach milestones with speed and capital efficiency. The company has experience in complex development programs and accelerated approval pathways, leveraging core expertise in areas such as the 505(b)(2) pathway, oncology, rare disease, combination products, and digital therapeutics. Founded in 2003, Camargo is proud to support clients in more than 35 countries around the world. For more information, visit camargopharma.com.
Incannex is an innovator and developer of medicinal cannabinoid pharmaceutical products with global export capability. Incannex is currently undertaking significant clinical programs to develop four uniquely formulated products in its relentless pursuit of FDA registration and market exclusivity in obstructive sleep apnea, traumatic brain injury/concussion, SAARDS, and temporomandibular joint disorder. For more information, visit incannex.com.au.