The purpose of Kelai Pharmaceutical
Is to bring together powerful natural molecules with Advanced Drug Delivery systems to create safe, effective, and innovative therapies for addiction, mental health disorders, and related conditions.
Kelai creates profoundly safer and more effective pharmaceutical products sourced from nature, but made infinitely more impactful via a patented drug delivery platform which enables precision-dosing. The company is able to overcome the challenges of many botanical compounds such as poor bioavailability, heavy first pass metabolism, hepatotoxicity, and dose frequency - thus allowing these compounds to reach their full potential as disease interventions.
Made in Nature. Delivered with Technology
Our first two targets are Nicotine Addiction and Anxiety
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If you correct your mind, the rest of your life will fall into place.
- Lao Tzu
Problems That Still Need Solutions
Nicotine Addiction
- Smoking is directly associated in $1.4 trillion in health expenditures and productivity losses combined.
- Approximately 14% of the U.S. population, 34.1 million Americans, currently smoke cigarettes.
- 68% have stated they would like to quit smoking and 55% have made an attempt to quit
- Only 7.5% are successful
- Fear of weight gain discourages 50% of women and 26% of men who smoke from quitting
- Real average gain is 6-10 lbs
- Our first drug addresses nicotine addiction with a high potential to mitigate weight gain
- In 2019, the global market for nicotine addiction was valued at $6 billion. By 2026, the market is expected to reach $64 billion, growing at a CAGR of 16.9%.
Anxiety Disorders
- Anxiety disorders are the most common mental illness in the U.S., affecting 40 million adults (18.1% of the population) and 25.1% of children between 13 and 18 years old
- Only 36% get effective treatment
- Most effective drug treatments are still benzodiazepines
- Prescription benzodiazepine deaths increased 22% from 2019 to 2020
- In the same year deaths from illicit use increased by 520%
- Market is expected to reach 19.81 Billion by 2028, registering a CAGR of 2.4% (this is an estimated correction for a massive spike during the pandemic)
Other
- Additional addictions (stimulants, alcohol, opiate), TBI, ADD/ADHD, depression, seizure disorders
Nicotine Addiction Market
- Kava is an excellent target for this space
- 14% of US population currently smoke cigarettes and 68% of them would like to quit
- Chantix had been given a market value of $1B (IQVIA) but is facing a serious recall for nitrosamines
- Smoking Cessation Global Market Size $23 B
- Pharmaceutical Smoking Cessation Global Market Size $7.3 B
Advanced Drug Delivery Market
$310 BILLION GLOBAL MARKET
Driven by huge need in such areas as mental health (currently affecting 1 Billion people worldwide), and large increases in R&D spending, the global market for advanced drug delivery systems will grow from $231 billion in 2020 to $310 billion by 2025.
Core Advanced Drug Delivery Technologies
Transdermal (TDD)
Patches/Topicals
- Allows for a controlled and sustained release through the skin and controls both input and time of Active
- Pharmaceutical Ingredients (API’s)
- Over 35 years of expertise in Transdermal Drug Delivery
Oral / Transmucosal
Lozenges
- Allows for a controlled and sustained release through the oral mucosal with a high driving force to allow majority of API to go directly into bloodstream
- Soft Lozenges that can deliver API from 15 minutes to 5 hours depending on indication
Advanced Drug Delivery (ADD)
Controlled & Sustained Release
ADD products Control Input Rate into Blood
- Plasma level controls brain activity (entropy, receptor occupancy)
- Brain activity correlated w/Therapeutic Result (intensity rating)
ADD products Sustain the Input over prolonged periods of time
- Allowing Physician to Titrate dosage over time to get optimal results
Benefits of (ADD)
- High safety profile
- Increased Bioavailability
- Less active ingredient
- Better efficacy
- Fewer side effects
- Convenience
- For Children, Adults, and Elderly
- Faster pathway to/thru the FDA
- Prevent first pass Liver Metabolism
Kavalactones - Kava Kava (API)
Traditional use of kava in the South Pacific has been as a social tradition, an integral part of formal gatherings, ratification of important agreements, celebrations of achievements, births, weddings and deaths, offerings to the gods, or simply as a means to benefit the enjoyment of daily life.
The Kava experience is described as a relaxed state of mind without the marked euphoria, impaired decision making, or disinhibition as often seen with similar therapeutics such as alcohol and benzodiazepines. Such a uniquely mild yet noticeable shift without cognitive impairment or tolerance factors is the key reason kava stands out for development.
2 studies using ceremonial Kava have shown efficacy for smoking cessation (Fiji 1996 and New Zealand 2013) both showed over 30% efficacy.
Focused Active Pharmaceutical Ingredients
Kavalactones
NR + NAD + Salvinorin
Issues & Problems With Standard Drug Delivery
PEAKS
Waste drug, create adverse reactions
VALLEYS
No Therapy
Standard Drug Delivery Methods Have Issues
PEAKS
- Wasted Drug (APIs)
- Adverse Reaction
- Psychosis or Permanent Mental Health Issues
VALLEYS
- Micro Spikes
- Limited Therapeutic Benefit
- Gaps Between Treatments
Company Timeline & Clinical Pipeline
Contributions Into Kelai
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