Aphios® Pharma LLC is developing FDA-approved cannabis-based drugs for Cancer Pain, Opioid Addiction, and Multiple Sclerosis.

Problem

There is currently no effective method for delivering cannabis. For instance, when smoking or inhaling cannabinoids, the dosing is complex, and the impact is short-lived. And when taken orally, the cannabinoids rapidly break down with acute effects. 

Solution

We aim to develop nano-encapsulated cannabinoids by following the process below:

• Determine the best cannabinoids or combinations for treating chemotherapy-induced peripheral neuropathic pain, opioid addiction, and multiple sclerosis.
• Produce pharmaceutical-grade cannabinoids using our patented supercritical CO2 extraction and chromatographic purification technologies. 
• Nano-encapsulate these cannabinoids in biodegradable polymer nanospheres to sustain their release and improve oral bioavailability

Market

Chemotherapy Induced Peripheral Neuropathic Pain [CIPNP] 

• CIPNP is a common adverse effect of many anticancer drugs. Around 50% of cancer patients suffer from pain. 
• The global neuropathic pain market is estimated to reach $8.3 B by 2024. The CIPNP segment is estimated to be 42.4% of the global pain market
• Dana-Farber Cancer Institute reports that there is no precise treatment for CIPNP. There, thus exists a highly unmet medical need for therapeutics to treat CIPNP.
• There is widespread utilization of marijuana in the treatment of pain, but only acutely.  
• Research on CBD has shown that it inhibits paclitaxel-induced pain through serotonin 5-HT1A receptors. 
• Nanoencapsulation of CBD will improve transport to the stomach and sustain its release over an 8 to 24-hour period.

Opioid Use Disorder (OUD)

• The CDC reports that the rate of deaths from drug overdoses in the US has increased by 137%.
• There has been a 200% increase in death rates involving opioid pain relievers and heroin from 2000-2014.
• Unlike buprenorphine and methadone, CBD is not an opioid and does not exhibit any psychotropic effects.
• CBD has been shown to alleviate cue-induced opioid addiction behaviors and allosterically modulate the μ and δ-opioid receptors
• Nanoencapsulation of highly purified CBD will provide sustained treatment of chronic diseases such as pain and substance use disorder. 

Multiple Sclerosis

• MS affects 2.5 million people worldwide, of which 400,000 are in the USA and 500,000 in the EU; MS-related healthcare costs exceed $10 billion per year in the United States.
• CBD has multiple actions on key molecular neuroinflammation and neurodegeneration targets, with highly effective in vitro and in vivo bioactivities 
• Nanoencapsulation of CBD in biodegradable polymer nanospheres will improve oral bioavailability, sustained release, and efficacy.

Competition

Jazz Pharma

Our primary competition is Jazz Pharma, which recently acquired GW Pharmaceuticals for $6.7 Billion. GW Pharmaceuticals developed a CBD/THC mixture for Multiple Sclerosis and a purified CBD product for childhood epilepsy.

Limitations
Since their products are delivered orally, their impact is short-term. What differs from Aphios is the use of nanotechnology, which improves the bioavailability of the drug.

Funding

Aphios Corporation has already spent approximately $44M towards researching and developing nanotechnology and effective drug delivery methods. Grants, contracts, and institutions funded these initial discovery stages.

In addition, Aphios Pharma LLC is raising $5M through Regulation Crowdfunding. The purpose of this funding is to scale up manufacturing, conduct IND-enabling studies and file an IND with the FDA to complete Phase 2 clinical trials. This funding is available to the general public through a future equity agreement (SAFE).

Concurrently, Aphios Pharma LLC is raising $25M through Regulation A. This funding will help complete the technology development and conduct clinical trials on nano encapsulated cannabinoid products. The primary investor for this type of funding will be institutions.