NanoDOX® Topical Gel - Phase 2 clinical study

Doxycycline (CAS: 17086-28-1)

Broad-spectrum antibiotic and anti-inflammatory

Doxycycline is a tetracycline antibiotic used systemically to treat inflammatory-dermatologic conditions. Several studies in human and animal models have shown doxycycline has anti-inflammatory and pro-healing properties, mainly by blocking tissue proteolytic activity.

Nanopharmaceutics is developing Doxycycline Monohydrate Hydrogel (NanoDOX®) for the treatment of Atopic Dermatitis (AD) and other skin infections.

AD a common chronic, relapsing, inflammatory skin disease (occurring in up to 20% of children and 3-6% of adults in the U.S., alone). AD is characterized by skin barrier disruption and an aberrant immune response (e.g. Th2 polarized) to environmental allergens. To date, AD treatments have targeted inflammation with the widespread use of topical and intermittent use of systemic immunomodulators. Despite its high prevalence, negative effects on quality-of-life and economic burden, there are few effective treatments for AD. The company’s long-term goal is to develop a better alternative treatment option.

A recently completed 6-week pilot study at the UF Health Dermatology Department- Springhill, revealed the safety and clinical efficacy of NanoDOX® Hydrogel in AD. Subjects enrolled in the study (15, 11F and 4 M) applied NanoDOX® Hydrogel 1% once daily at bedtime for total of four weeks (or until complete clearance) on the chosen target eczematous area. The drug was shown to be well tolerated with no local or systemic adverse events reported. Notably, a significant clinical improvement was observed from Visit 1 (start of treatment) to visit 2 (14 days treatment) and visit 3 (28 days treatment) respectively, providing key data to bolster further investigation of the use of a non-systemic doxycycline as a potential novel treatment option for AD.

NanoDOX® topical gel is currently entering a Phase 2 clinical study with Massachusetts General Hospital (Clinicaltrials.gov NCT05411484).

Clinical Studies (Active)

  • NCT05411484 Investigation of Laser Assisted Drug Delivery of NanoDOX®

Clinical Studies (Completed)

  • NCT02910011 Topical NanoDox® for Atopic Dermatitis

  • NCT00764361 Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

Intellectual Property

Nanopharmaceutics holds world-wide exclusive rights to U.S. patents 11,291,673 and 11,202,788 and related foreign filings.

References

Topical doxycycline monohydrate hydrogel 1% targeting proteases/PAR2 pathway is a novel therapeutic for atopic dermatitis. Bohannon M, Liu M, Nadeau P, Talton J, Gibson D, Datta S, Schultz G, Talton J, De Benedetto A. Exp Dermatol. 2020 Dec;29(12):1171-1175. doi: 10.1111/exd.14201. Epub 2020 Oct 15. PMID: 32997843.