Nexien BioPharma Profile
Nexien BioPharma, Inc. engages in the business of developing drugs containing cannabinoids for the treatment of various diseases, disorders and medical conditions; the development or licensing of proprietary delivery systems for cannabinoid-based1 pharmaceutical medications; and the investment in companies and the acquisition of technologies or medications, focused on cannabinoid-based science through special purpose vehicles.
The company is utilizing cannabinoids as the active pharmaceutical ingredients to develop synthetic pharmaceuticals in strict accordance with the U.S. Food and Drug Administration (FDA) pre-clinical and clinical pathways.
The company’s flagship research and development programs are focused on advancing formulations that have the potential to significantly improve the treatment outcomes of certain convulsive disorders and neuromuscular disorders. The company is seeking a business combination opportunity and maintaining the intellectual property assets.
Drug Development Activities
Due to the significant amount of financing needed to develop and commercialize a new drug and the company’s limited resources, it is focusing its efforts on advancing formulations that have the potential to significantly improve the treatment of myotonic dystrophy.
Myotonic Dystrophy
The company’s patent applications relate to methods and compositions for treating such diseases with the use of cannabinoids and covers the administration of the drug(s) by such delivery systems as topical, oral, nasal, inhalation or a combination thereof. On July 07, 2020, a utility patent was granted (US10702,495) relating to a method for treating the symptoms of myotonia with a therapeutically effective amount of cannabidiol and tetrahydrocannabinol in a subject. Corresponding claims were also submitted in Europe.
In 2018, the company retained Dr. Benedikt Schoser, a world-renowned expert in DM, to advise the Company. To elicit further information regarding whether DM patients have had any experience with cannabis and if so whether such experience has resulted in any symptom relief, a questionnaire was sent to a number of DM 1 and DM 2 patients by patient organizations. The results of the questionnaire suggest further exploration is appropriate.
In 2019, the company filed a pre-IND meeting request (the Request) to discuss the requirements for submission of an Investigation New Drug Application for a combination of Cannabidiol and THC Sublingual Tablet for muscle relaxation in patients with myotonic dystrophy and for the treatment of myotonia. In 2019, the company received written responses from the FDA to the questions it raised in the pre-IND meeting request.
Drug Delivery System Development Activities
Accu-Break License Agreement
In 2018, the company obtained a worldwide exclusive license from Accu-Break Pharmaceuticals, Inc., a Florida corporation (Accu-Break) with respect to a proprietary delivery system for cannabinoid-based medications.
Patents, Intellectual Property and Proprietary Rights
The company’s patent application for Method and Compositions for Treating Dystrophies and Myotonia was granted on July 7, 2020, by the U.S. Patent and Trademark Office.
In addition, on June 8, 2018, a U.S. Patent Application was filed relating to the use of cannabinoid receptor modulators and/or terpenes to treat extreme health hazards due to exposure to organophosphorus nerve agents and/or organophosphorus insecticides. A continuation was filed on August 01, 2020, relating to a compound disclosed in the patent application with pending applications in Europe and Canada. An Israeli patent (238946) was granted on July 01, 2019, for the Use of Cannabinoids and Terpenes for Treatment of Organophosphate and Carbamate Toxicity based on licensed technology from Kotzker Consulting LLC.
Government Laws and Regulations
The U.S. Food, Drug, and Cosmetic Act and its implementing regulations set forth, among other things, requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of the company’s drugs.
History
The company was formerly known as Intiva BioPharma Inc. and changed its name to Nexien BioPharma, Inc. in 2018.
