Skye Bioscience (SKYE): A clinical stage biotech company working to unlock the pharmaceutical potential of the endocannabinoid system to treat several impactful diseases, including obesity
Renewed Pharma and institutional investor interest in CB1 receptors for weight loss could be a sign that underfollowed Skye Bioscience, Inc. (OTCQB: SKYE) is uniquely positioned in the rapidly growing obesity drug market
Skye is a biotech company developing proprietary molecules to treat diseases involving neurodegenerative, inflammatory, fibrotic, and metabolic conditions
The Company’s focus is on advancing first-in-class drugs with potential to provide new therapeutic outcomes for diseases with significant prevalence and unmet needs
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SKYE is unlocking the pharmaceutical potential of the endocannabinoid system (ECS) through modulation of the CB1 receptor
There is growing momentum in the endocannabinoid drug development frontier. Research suggests that the ECS may be a potential therapeutic target for numerous physiological conditions, including metabolic function and appetite regulation.
An opportunity revisited…
A promising class of obesity drugs - the cannabinoid receptor-1 inhibitor.
- Glaucoma
- Pain
- Cognitive function
- Neuroprotection
- Appetite regulation
- Weight loss
- Insulin sensitivity
- Kidney function
What do CB1 receptors do?
CB1 receptors make up one piece of a biological system called the endocannabinoid system (ECS). The ECS controls many basic biological processes, and exerts its activity in the nervous system and in the peripheral tissues, with direct involvement in food intake, energy balance, neuroprotection, pain control, sleep, mood, behavior and much more. As a consequence, ECS impairment has been reported in several diseases and its modulation represents therapeutic opportunities by targeting its receptors, such as CB1, for the treatment of multiple diseases.
How can CB1 receptors be influenced for therapeutic purposes?
While CB1 receptors are generally expressed in the brain and other parts of the central nervous system, there is convincing evidence of disorders in which the ECS, specifically the CB1 receptor, are upregulated in peripheral tissues in a manner that exacerbates certain disorders, such as obesity and kidney disease. As a result, blocking or inhibiting the CB1 receptor has been shown to have beneficial therapeutic effects. The most well known example of this was with a drug called rimonabant.
Years ago, CB1 receptors were looked at as potential therapeutic target for weight loss drugs. CB1-targeting drugs were poised to make a positive impact in this disease, until significant side effects derailed the commercialization of these drugs.
While Sanofi won clearance in Europe for its drug, rimonabant or Acomplia, it failed to gain support from the FDA’s outside advisors and was pulled from the European Union in 2009 over safety concerns. Because it acted on the brain, some of the side effects it caused were anxiety, depression, and suicidal thoughts.
Rimonabant had however demonstrated up to 10% weight loss over 1 year and improvements in metabolic outcomes.
Giants like Merck, Pfizer, Solvay, and other drug developers wound up sidelining similar assets over the side effect concern. This pullback by Big Pharma caused a setback in development of CB1 inhibitors.
More recently, a few innovative biotech companies developed new generations of CB1-targeting drugs, designing them with the goal of averting the detrimental effects in the brain. SKYE’s innovative technology is a differentiated approach that may overcome the key weakness of the 1st generation CB1 inhibitors to provide a safe and effective approach towards CB1 inhibition that could position CB1s to realize the therapeutic potential that their results suggested years ago.
With its leading effort to realize the pharmaceutical potential of endocannabinoid receptors, CB1 biotech company Skye Bioscience, Inc. (OTCQB: SKYE) is entering an important stage of its development.
With the potential of CB1 becoming clearer, distinct opportunities for SKYE are also emerging...
Company Overview:
Backed by leading biotechnology venture investors, SKYE’s strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation.
The company is focused on leveraging an important physiological system, the endocannabinoid system, that has only been recognized since the 1970s and is relatively underappreciated as a target for drug development.
SKYE aims to develop novel drugs with potential to treat glaucoma and other significant disease areas involving fibrotic, inflammatory and metabolic processes by targeting the CB1 receptor.
Why did specialized life science venture investors forge a deal to cannabinoid to endocannabinoid-targeting
Spurred by rising interest in molecules targeting endocannabinoid receptors to treat a range of diseases, specialized life science VCs joined forces with SKYE to develop therapies that target CB1. They facilitated a $20 million purchase that enabled Skye Bioscience Inc. (OTCQB:SKYE) to acquire Bird Rock Bio Inc’s nimacimab asset. They then invested $12 million in a PIPE deal to fund Skye’s operations and advance two molecules toward Phase II studies.
The deal set up SKYE to start its first Phase II study of its CB1 agonist/activator, SBI-100 OE, to treat glaucoma. It also allowed SKYE to start preparing its newly acquired Phase 2-ready drug nimacimab, a negative allosteric modulator of CB1, for a planned Phase 2 study for metabolic conditions with an emphasis on obesity and chronic kidney disease (CKD).
Studies have demonstrated a strong correlation between obesity and the development and progression of CKD. Obesity is intimately linked to hypertension and diabetes—the two biggest contributors to the development of kidney disease.
Nimacimab:
The company’s nimacimab is a peripherally acting CB1 inhibitor, a new approach to potentially address diseases such as obesity, pulmonary fibrotic diseases of the lungs, increased fat in the liver, and kidney function.
Early generations of CB1 inhibitors for weight loss acting on the central nervous system (CNS) showed efficacy but experienced setbacks, sometimes causing anxiety, depression, and suicidality.
As a monoclonal antibody, nimacimab does not easily cross what is called the “blood-brain barrier” and acts outside of the CNS. Animal toxicity studies showed no drug accumulation in the brain - a differentiating positive result.
- A Phase 1b study showed excellent safety with no adverse events of concern and encouraging trends in exploratory biomarkers after three-week dosing.
- Skye is planning to start a Phase 2 study focused on an obesity and chronic kidney disease in H1 2024.
Establishing proof-of-concept could pave the way to potentially address multiple diseases with significant prevalence and unmet need.
SKYE’s nimacimab, a next-generation CB1 inhibitor, could be a promising solution to help address obesity: a rapidly growing condition with notably detrimental health effects.
The impact of drugs like Ozempic and Wegovy has made numerous headlines in 2023. Celebrities, athletes, and regular people have been turning to these drugs to lose weight.
Semaglutide falls under a drug class called GLP-1 receptor agonists, which attach to GLP-1 receptors in the body and produce more insulin, helping to lower blood sugar levels and decrease appetite.
U.S. doctors have been writing out millions of prescriptions for obesity drugs including semaglutide (sold under the brand names Ozempic, Wegovy) in the last year. This growth in prescriptions has translated into rapid sales growth for the two pharmaceutical company leaders in this space, Novo Nordisk and Eli Lilly.
But there’s a problem….
Studies have found that semaglutide leads to a significant decrease in fat-free mass (aka muscle mass) compared with a placebo. Furthermore, because this drug is focused on reducing appetite, if patients go off the drug their food consumption increases and they readily regain weight.
SKYE’s nimacimab uses a different mechanism with the goal of achieving important, long-lasting impacts on weight and related conditions such as kidney diseases. Biotech observers believe there are numerous opportunities for differentiated and improved therapeutic outcomes in the burgeoning weight loss and cardiometabolic space. If nimacimab can build on the positive prior evidence of CB1 inhibition in its upcoming clinical trial and beyond, there is a clear opportunity for it to play a distinct role in this emerging future.
About SBI-100 Ophthalmic Emulsion:
Skye's SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation that were designed to enable effective topical delivery and better penetration of a CB1 agonist into ocular tissue.
In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering intraocular pressure, comparing favorably to the standard of care for treating glaucoma.
The company recently announced successful results from its Phase 1 clinical trial assessing the safety and pharmacokinetics of SBI-100 Ophthalmic Emulsion ("OE").
This first-in-class cannabinoid type 1 receptor ("CB1") agonist is a prodrug uniquely formulated as an eyedrop and is being developed as a potential new mechanism to address unmet needs in the treatment of glaucoma.
"Our Skye team is proud to have completed our first human trial of an ophthalmic drug targeting the CB1 receptor and accomplishing a major step on our journey to provide ophthalmology healthcare professionals, and their glaucoma patients, access to a new class of medicine. There remain notable unmet needs in the treatment regimen for glaucoma. A notable portion of glaucoma patients fail their initial prescribed medications. In addition, hyperaemia, or red eyes, is a common side effect of glaucoma drugs and is a major reason for patients discontinuing these treatments. We believe that SBI-100 OE has a distinct potential role to play as a new mechanism for this disease."
Punit Dhillon, CEO and Chair of Skye
Top Reasons to Have SKYE on Your Radar:
- Big pharma is seeing the appeal of CB1 receptors: Recent acquisitions highlight interest in the ECS: Jazz Pharmaceuticals/GW Pharmaceuticals/epilepsy (2021); Horizon/Zynerba/Fragile X drug (2023); in 2023, the largest seller of drugs used for weight loss, Novo Nordisk, acquired Inversago Pharma and its peripheral CB1-inhibiting drug (with Phase 1 data).
- Experienced leadership: Contributed to the commercialization of 47+ drugs/diagnostics, led high-value strategic transactions, and co-founded multiple companies.
- Promising outlook: The company has strong execution, a strong track record, and a clear clinical path forward.
- Growing market for obesity drugs: Wegovy and Ozempic sales have ballooned in recent years and the company has a product that could potentially play a vital role as a single or combination drug in this market - one that may not cause muscle loss or CNS liabilities!
- High unmet need among glaucoma patients. Eyecare providers are showing a high level of familiarity and enthusiasm for a pharmaceutical-quality CB1 agonist as a new class of drug for glaucoma.
In Summary….
Focusing on the endocannabinoid system (ECS) may be the answer to the development of improved drugs for key diseases. This may be game-changing for SKYE as it advances through the clinic with a potential new drug in the obesity and glaucoma markets.
The success of new drugs for obesity is creating even greater enthusiasm for and investment in drugs that may further advance their benefit for weight loss and other related cardiometabolic conditions, and also potentially create opportunities for combinations with the current leading drugs, Wegovy and Ozempic. This in turn is creating an important opportunity for Skye to advance its unique drug, nimacimab.
Backed by leading biotech venture investors, Skye Bioscience, Inc. (OTC: SKYE) is spearheading its own distinct approach to realize the potential for CB1 receptors to positively impact the medical landscape.
Learn More about Skye Bioscience, Inc. by gaining access to their comprehensive investor presentation
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