Zylö and Hoth Therapeutics Forge Partnership to Develop Endocannabinoid-Based Drug to Treat Lupus

Greenville, SC: Zylö Therapeutics, dedicated to bringing innovative topical technologies to multiple facets of medicine, has entered into a definitive partnership agreement with Hoth Therapeutics (Nasdaq: HOTH) to develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus [CLE], a chronic autoimmune disease that affects the skin.

Hoth, a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from dermatological indications ranging from atopic dermatitis to chronic wound disorders, has an exclusive license to develop Anandamide-loaded Z-pods™—the trade name used for Zylö’s patented xerogel particles—for the treatment of CLE in North America. Anandamide, generally referred to as AEA, is one of the cannabinoids that the human body makes naturally.

Hoth also has certain rights related to geographic expansion and to follow-on indications such as psoriasis and rheumatoid arthritis.

Scientists at the Albert Einstein College of Medicine, where the platform technology was originally developed, have demonstrated that topical administration with AEA-loaded Z-pods™ inhibits the development of CLE lesions in a well-established animal model of lupus. This work reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases.

The work at Einstein supports the thesis that AEA-loaded Z-pods™:
- improve drug penetration
- prevent the development of skin lesions
- improve skin histopathology
- reduce macrophages and C3 accumulation
- reduce inflammatory cytokine secretion by keratinocytes
- have no deleterious effect on antibody levels

According to estimates by the Lupus Foundation of America [LFA], 1.5 million Americans currently suffer from lupus, with 16,000 new cases reported annually; tragically, lupus strikes mostly women of child-bearing age and is 2-3 times more prevalent amongst women of color. Worldwide, the LFA estimates that at least five million people have some form of the disease. Of those diagnosed, approximately two-thirds will develop CLE. The average cost to provide medical treatment for a person with lupus is well over $10,000 per year.

“Zylö’s initial work with AEA-loaded Z-pods shows significant promise in treating CLE, and we look forward to collaborating with them to bring this treatment to market,” stated, Robb Knie, CEO of Hoth.

“We are thrilled to partner with Hoth, an innovative company committed to developing treatment solutions for diseases—such as lupus—with a high unmet clinical need,” said Scott Pancoast, CEO of Zylö. “As we collaborate with the Hoth team to advance AEA-loaded Z-pods through the next stages of development, we expect to further demonstrate the critical role that our patented Z-pod delivery system plays in improving therapeutic outcomes.”

About Zylö Therapeutics: Zylö has developed a xerogel-derived topical delivery system that extends the duration-of-effect, improves the solubility/targeting, and/or enhances the product performance of many therapeutic agents. Notably, the Z-pod™ technology platform has enabled the Patchless Patch™ concept and has successfully harnessed the therapeutic potential of nitric oxide, one of the most powerful—and short-lived—biomolecules produced by the human body.

Scott R. Pancoast, CEO
(858) 775-6710
spancoast@zylotherapeutics.com

www.zylotherapeutics.com