FACILITATING AN UNMET NEED BY REDUCING COSTS AND INCREASING EFFICACY

An orally available, specific agonist of α7 NAChR agonist is distinguished from other anti-inflammatory agents because it stimulates a naturally occurring neuroimmunological pathway. Consequently, the agonist should exhibit broader activity than antibody therapy (anti-TNF, anti-IL6R) and be more effective than NSAIDs with limited deleterious indications that are characteristic Jak inhibitors. We envision an effective agonist to be safe and widely effective in a broad spectrum of inflammatory indications.

The envisioned price of such a therapeutic would be significantly less than the antibody therapies.

PRIMARY TARGET INDICATIONS

GASTROINTESTINAL
DISORDERS
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Gastrointestinal disorder is mainly associated with the impairment of gastrointestinal functions that are affected mainly by contaminated or poisonous food. Gastrointestinal disorders includes irritable bowel syndrome, gastroesophageal reflux diseases and peptic ulcer diseases. These are the functional disorders in which gastrointestinal bowel doesn’t work properly. Bleeding, gastrointestinal infections and diarrhea are some of the common symptoms during gastrointestinal disorder. Nexium, Aciphex, Tysabri, Humira are some of the gastrointestinal therapeutics commercially available in the market.

The global gastrointestinal therapeutics market size was valued at $51.9B USD in 2016 and is slated to expand at a lucrative CAGR of 6.6% over the forecast period. Increasing adoption of biologics for treatment of gastrointestinal diseases is the primary driver of the market. According to the Centers for Disease Control and Prevention (CDC), it is estimated that approximately 1-1.3 million people are suffering from Inflammatory Bowel Disease (IBD) in U.S. Prevalence of Crohn’s disease and ulcerative colitis is 201 per 100,000 adults and 238 per 100,000 adults, respectively.

Source: https://www.businesswire.com/news/home/20180129005741/en/Global-27.3-Billion-Multiple-Sclerosis-Drugs-Market Source: https://www.persistencemarketresearch.com/market-research/gastrointestinal-disorder-therapeutics-market.asp Source: https://www.grandviewresearch.com/industry-analysis/gastrointestinal-therapeutics-market
GOUT
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Gout is a form of inflammation characterized by recurrent attacks of a red, tender, hot, and swollen joint. Pain typically comes on rapidly in less than twelve hours. The joint at the base of the big toe is affected in about half of cases. It may also result in tophi, kidney stones, or urate nephropathy.

Gout in the United States has risen over the last twenty years and now affects 8.3 million Americans. Prevalence of increased uric acid levels (hyperuricemia) also rose, affecting 43.3 million adults in the U.S. Greater frequency of obesity and hypertension may be associated with the jump in prevalence rates, according to the findings.

The treatment of gout is confounded in patients with multiple comorbidities and/or contraindications to current therapies, and by current treatment paradigms that fail to address the etiology of hyperuricemia in the vast majority of patients.

Source: FULD+Company Analyst Report, Market and Competitive landscape for Medical Marijuana and Synthetic Cannabinoid
MULTIPLE SCLEROSIS BOTH
RELAPSING AND PROGRESSIVE FORMS
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This is a condition which can affect the brain and/or spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance.

The global market for MS as of 2017 has increased drastically from $14.3B USD in 2012 to $21.5B USD. It is expected to reach $27.38B USD by 2025, expanding at a CAGR of 6.3% from 2017 to 2025.

The Multiple Sclerosis Foundation estimates that more than 400,000 people in the United States and about 2.5 million people around the world have MS. About 200 new cases are diagnosed each week in the United States

Spasticity is a common symptom in MS. Although spasticity of varying severity affects up to 80% of patients with multiple sclerosis (MS) during the course of their disease, the symptom is often overlooked and undertreated. Despite the availability of oral ant spasticity treatments (baclofen, tizanidine and others), approximately one-third of MS patients in Europe and the USA experience moderate or severe non-focalized spasticity.

Source: https://www.businesswire.com/news/home/20180129005741/en/Global-27.3-Billion-Multiple-Sclerosis-Drugs-Market

SECONDARY TARGET INDICATIONS

RHEUMATOID
ARTHRITIS
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The rheumatoid arthritis space across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Australia, is set to grow from $19.5B USD in 2015 to around $28.5B USD by 2025, representing a compound annual growth rate of 3.9%, according to GlobalData, a recognized leader in providing business information and analytics.

The burden of Rheumatoid Arthritis (RA), a chronic, progressive, and currently incurable autoimmune disease that primarily affects the joints, is considerable. It is estimated to affect approximately 4.9 million people across the major markets as of 2015 . It is costly to healthcare services and leads to substantial economic and quality of life impairments for patients, at least 50% of whom are unable to maintain full-time employment within 10 years of onset.

Source: https://www.globaldata.com/rheumatoid-arthritis-market-will-hit-28-5-billion-2025-says-globaldata/ Source: http://www.gbiresearch.com/report-store/market-reports/therapy-analysis/rheumatoid-arthritis-market-to-2020-a-crowded-market-characterized-by-modest-growth
OSTEOARTHRITIS
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The US Centers for Disease Control (CDC) and World Health Organization estimates that presently 30 million US adults and 40 million European adults are affected by osteoarthritis. These numbers are expected to significantly increase as the US and EU populations age. By 2040, an estimated 78 million US adults are projected to have doctor-diagnosed arthritis. In 2017, the global osteoarthritis treatment market was valued at $7.9B USD and is expected to reach $11.6B USD by 2025. If the US market share is estimated at 35% and Europe is estimated at 25%, the projected 2025 market values are $4B USD and $2.9B USD, respectively

Osteoarthritis treatment is a significant unmet need because the present, dominant treatment options; NSAIDS, corticosteroids, and hyaluronic injections lack long term efficacy and have significant side effects such as kidney complications, osteoporosis, weight gain, high blood pressure, stomach/intestine bleeding or perforation and ulcers. As many as 25% of frequent NSAID users develop ulcers. The US FDA also released a warning that prolonged use of NSAIDs, other than aspirin, can increase the risk of heart attack and stroke.

Source: FULD+Company Analyst Report, Market and Competitive landscape for Medical Marijuana and Synthetic Cannabinoid
ATHEROSCLEROSIS
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This is a disease in which plaque builds up inside your arteries. Arteries are blood vessels that carry oxygen-rich blood to your heart and other parts of your body. Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows your arteries.

The rise in the aging population is expected to propel demand over the forecast period. As per CDC (Centers for Disease Control and Prevention), coronary illness accounts for around 610,000 deaths per year in the United States- roughly being responsible for 1 of every 4 deaths reported. Coronary illness is the most widely recognized kind of coronary illness, killing more than 370,000 individuals every year.

Atherosclerotic cardiovascular disease is the leading cause of death worldwide. Despite extraordinary advances in the understanding of the pathophysiology and the utilization of very effective medications such as statins, there still remains a significant residual risk. In fact, even after optimal interventional and medical therapy, the possibility of recurrent myocardial infarction remains at approximately one third for five years after acute coronary syndromes, thus emphasizing the urgent need for novel therapies to prevent the progress of atherosclerosis. In addition, over the past two decades, although atherosclerosis has been clearly identified as an inflammatory disease of the arterial wall from compelling data of animal and human studies, clinical applications related to this accumulated knowledge are scarce.

Source: FULD+Company Analyst Report, Market and Competitive landscape for Medical Marijuana and Synthetic Cannabinoid