Woburn, Mass. – July 06, 2018 − Aphios® Pharma LLC incorporates as a Delaware-based limited liability company to develop an FDA-approved, cannabis-based drug for treating opioid addiction, a highly unmet Central Nervous System (CNS) disorder, and other debilitating CNS disorders such as pain, epilepsy, cancer induced nausea and vomiting and Multiple Sclerosis (MS).
Aphios® Pharma is dedicated to the discovery, nanotechnology delivery, development and commercialization of cannabis-based drugs for CNS and other debilitating disorders. We will manufacture and utilize pharmaceutical-grade pure natural cannabinoids in stable, bioavailable nanoformulations, following cGMP guidelines of the FDA. These cannabinoid nanoformulations will be used to establish clinical evidence for treating highly unmet CNS disorders such as opioid addiction and pain, epilepsy including childhood epilepsy and multiple sclerosis that are only partially and anecdotally addressed by medical marijuana.
Apart from the recent FDA approval of Epidiolex (GW Pharma, London, England) for specific cases of childhood epilepsy, there is little rigorous clinical evidence of the efficacy of cannabinoids for significant CNS neurological disorders, and a lack of availability of pharmaceutical-grade cannabinoids to conduct rigorous clinical studies. These issues are compounded by a prohibitive DEA, NIH and FDA regulatory environment for developing FDA-approved, cannabis-based drugs. From a technical perspective, cannabinoids are very hydrophobic (poorly water soluble) making formulation difficult and bioavailability poor; also, cannabinoids are very oxygen sensitive and unstable, contributing to inconsistencies in therapeutic performance.
From a drug development perspective, cannabinoids are very hydrophobic (poorly water soluble) making their formulation difficult and bioavailability poor. Cannabinoids are also very sensitive to oxygen and unstable, leading to inconsistencies in therapeutic performance. Dr. Castor explains that “Aphios® Pharma plans to avoid these issues by nanoencapsulating cannabinoids in biodegradable polymer nanospheres using proprietary and patented SuperFluids technologies to significantly improve cannabinoids stability as well as bioavailability and therapeutic efficacy.”
We plan to develop, in compliance with the Drug Enforcement Agency (DEA), FDA-approved cannabinoid therapeutics that target opioid addiction and pain [APH-1501]; adult epilepsy [APH-1502]; chemotherapy induced peripheral neuropathic pain (CIPNP) [APH-1503]; multiple sclerosis [APH-1403]; and chemotherapy induced nausea and vomiting (CINV) and cachexia [APH-0802]. Our next steps are preclinical studies, scale-up, nonclinical studies, an investigational new drug (IND) application and Phases 1/2 and 3 clinical trials, followed by a new drug application (NDA) and product launch. We plan to accelerate this process through the FDA’s 505(b)(2) regulatory approval pathway based on the recent FDA drug approval of CBD. At the end of successful or promising Phase 1/2 clinical trials, certain products will be out-licensed and/or the company may be acquired by a third party.
We are raising $25 million from individual investors, strategic corporate partners and institutional investors to initiate execution of its business plans prior to filing an initial public offering (IPO) to complete clinical development of its products. This investment will be used to take the developed cannabinoid nanoformulations through the development cycle and Phase 1/2 clinical trials. Within a 2-year period, we will raise an additional $200 million to conduct Phase 3 clinical trials, get FDA approval and commercialize these products with a direct sales force.