8-K: Skinvisible Announces Promising Transdermal Obesity Formulation Results

Skinvisible's proprietary Invisicare technology demonstrates significant transdermal delivery of glucose-controlling agents, potentially revolutionizing obesity treatment.

Summary

• Skinvisible Pharmaceuticals has announced the publication of an article highlighting the successful transdermal delivery of glucose-controlling agents using their Invisicare technology.
• The article, published in Drug Development & Delivery, details the results of studies showing a 99.6% transdermal penetration of a GLP-1 active over six hours.
• The company is also working on other GLP-1 agonists and CB-1 antagonists, with CB-1 antagonists showing 62% penetration over 6 hours.
• The Invisicare technology, a polymer delivery vehicle, does not require patches or needles for transdermal delivery.
• Skinvisible has filed two provisional patent applications covering formulations that use Invisicare for transdermal administration of glucose-controlling agents.
• The company is actively seeking strategic partnerships to bring these transdermal obesity therapies to market.
• The global market for obesity drugs is projected to reach $105 billion to $144 billion by 2030.

Sentiment

Score: 8

Explanation: The document presents very positive results for the company's transdermal drug delivery technology, with high penetration rates and a large potential market. The company is actively seeking partnerships, which is a positive sign. However, it is still an emerging company with risks.

Positives

• The Invisicare technology offers a non-invasive approach to delivering obesity and glucose-controlling agents.
• Transdermal delivery avoids first-pass metabolism, potentially reducing side effects associated with oral medications.
• The cream formulations offer a painless alternative to injections and can be used for maintenance therapy.
• The company is actively seeking strategic partnerships to commercialize their technology.
• The technology has potential for use with other small molecules in the obesity space and other indications.

Risks

• The company is an emerging company and faces risks associated with product development and market acceptance.
• The ability of product candidates to be approved by the U.S. Food and Drug Administration is uncertain.
• Actual results could differ materially from forward-looking statements due to various risk factors.

Future Outlook

Skinvisible is actively seeking strategic partnerships to bring the first transdermal obesity therapies to market and explore broader applications of its delivery platform.

Management Comments

• James Roszell, PhD, Skinvisibles Head of R&D, stated that the Invisicare based transdermal formulation of a GLP-1 active showed significant (99.6%) transdermal delivery over a six-hour period.
• Terry Howlett, President & CEO of Skinvisible, said that Skinvisible's Invisicare technology offers a novel approach to obesity drug administration.
• Terry Howlett also stated that their innovative topical formulations can deliver significant amounts of medication systemically, potentially avoiding the side effects associated with oral pills and injections while increasing patient compliance.

Industry Context

The announcement comes amid a growing global obesity epidemic and a rapidly expanding market for obesity drugs, with the market projected to reach $105 billion to $144 billion by 2030. Skinvisible's transdermal technology offers a novel approach compared to traditional oral and injectable treatments.

Comparison to Industry Standards

• Traditional obesity treatments often involve oral medications or injections, which can have side effects and compliance issues.
• Skinvisible's transdermal approach, using Invisicare technology, offers a potential alternative by avoiding first-pass metabolism and providing a painless delivery method.
• The 99.6% transdermal penetration of a GLP-1 active over six hours is a significant result compared to other transdermal delivery systems.
• While specific competitor results are not detailed in the document, the high penetration rates and sustained delivery suggest a competitive advantage for Skinvisible's technology.

Stakeholder Impact

• Shareholders may benefit from the potential commercialization of the Invisicare technology.
• Patients may benefit from a more convenient and less invasive treatment option for obesity.
• Potential partners may benefit from access to Skinvisible's innovative delivery platform.

Next Steps

• Skinvisible is actively seeking strategic partnerships with pharmaceutical and biotech companies.
• The company will continue to develop and expand its portfolio of obesity-targeting formulations.

Key Dates

Keywords

transdermal, obesity, Invisicare, GLP-1, drug delivery, glucose-controlling agents, pharmaceutical, topical, formulation, patent