Israeli firm Innocan Pharma has taken a step towards FDA approval for its CBD liposome drug, which could have a range of applications, including epilepsy, pain relief and central nervous system disorders.
The product has completed its physico-chemical characterisation, an important part of the application package to be submitted to the FDA.
It is also a crucial milestone towards a potential submission of an Investigational New Drug Application (IND) and New Drug Application (NDA) file, following completion of toxicology, pharmacokinetics and efficacy studies.
Innocan has an exclusive license agreement with Yissum, the commercial arm of The Hebrew University of Jerusalem, to develop a CBD drug delivery platform based on a unique-controlled release liposome to be administered by injection.
Working with the head of the university’s membrane and liposome research department, Professor Chezy Barenholz, the firm plans test the liposome platform on several potential conditions.
It is also working on a dermal product that integrates CBD with other pharmaceutical ingredients; as well as the development and sale of CBD-integrated pharmaceuticals; including topical treatments for the relief of psoriasis symptoms and the treatment of muscle and rheumatic pain.
Prof. Barenholz said: “Profile characterisation is a cornerstone of the FDA drug delivery protocol. I’m deeply encouraged by the advancement of this process.”
Iris Bincovich, CEO of Innocan, said: “Our R&D efforts are becoming our crown jewel. I’m thrilled to report this achievement. I am encouraged by our ability to follow and adhere to FDA regulations.”
The Hebrew University has led the invention of 55+ patent families, two of which underlie Doxil, an FDA-approved drug for breast cancer treatment.
Innocan Pharma is focused on the development of several drug delivery platforms containing CBD.
It is collaborating with Ramot at Tel Aviv University on a new exosome-based technology that targets both central nervous system indications and Covid-19 using CBD.
CBD-loaded exosomes hold the potential to help in the recovery of infected lung cells. This product, which is expected to be administered by inhalation, will be tested against a variety of lung infections.
