Data Summary

BIOAVAILANT® has been evaluated across multiple translational models, including ex vivo human skin studies, local tissue bioavailability studies, and preclinical systemic delivery studies. These data support the platform’s potential for topical, transdermal, ocular, local tissue, and systemic delivery of biologics and other hard-to-deliver macromolecules.

Validation Highlights

Ex Vivo Human Skin Delivery — PD-1 Checkpoint Inhibitor

  • Ex vivo human skin studies evaluated topical delivery of a PD-1 checkpoint inhibitor using the BIOAVAILANT® platform.

  • Distribution data demonstrated delivery into both epidermal and dermal compartments.

  • In one study, approximately 30% of recovered dose was localized in the epidermis and approximately 35% was localized in the dermis.

  • Receptor-phase recovery at 48 hours was approximately 6.1 µg/cm², supporting controlled transport through human skin.

  • These results support the potential application of BIOAVAILANT® for localized skin-directed immunotherapy, including checkpoint-inhibitor approaches for dermatologic oncology and related indications.

Systemic Transdermal Delivery — GLP-1 / Metabolic Disease Feasibility

  • Preclinical studies evaluated systemic transdermal delivery of a GLP-1 therapeutic candidate using the BIOAVAILANT® platform.

  • Data supported reproducible systemic exposure following topical/transdermal administration.

  • The absorption profile suggested potential for extended systemic delivery compared with conventional bolus-style administration.

  • The study supported feasibility for needle-free metabolic disease applications, including obesity and related cardiometabolic indications.

  • These findings provide translational support for further optimization of BIOAVAILANT® with selected peptide and protein therapeutics.

Systemic Delivery of Larger Therapeutic Proteins

  • Preclinical systemic delivery studies demonstrated transdermal bioavailability using an approximately 50 kDa therapeutic protein.

  • These results support the platform’s potential relevance for molecules substantially larger than conventional small-molecule transdermal candidates.

  • The findings help validate BIOAVAILANT® as a platform for hard-to-deliver biologics and macromolecules.

Local Tissue Bioavailability — Intra-Articular Biologic Delivery

  • Human microdialysis data from a pharmaceutical co-development program demonstrated local tissue bioavailability with an approximately 10 kDa biologic.

  • The biologic was highly unstable and difficult to deliver by conventional approaches.

  • The study demonstrated approximately 39% absolute bioavailability in the targeted joint-space environment.

  • These results support BIOAVAILANT®’s potential for local tissue delivery where high local exposure may be desirable while limiting systemic burden.

Platform Implications

  • BIOAVAILANT® supports both local tissue delivery and systemic delivery across selected translational models.

  • Data support potential use with proteins, peptides, checkpoint inhibitors, biologics, and other macromolecules.

  • The platform may enable differentiated development strategies in immuno-oncology, dermatology, metabolic disease, ophthalmology, inflammatory disease, and musculoskeletal applications.

  • The system is being developed as a non-invasive, cream-based alternative to injection, infusion, or device-based administration for selected therapeutic opportunities.

Summary

Collectively, these studies support BIOAVAILANT® as a differentiated delivery platform with demonstrated activity across local, systemic, and skin-directed delivery models. The platform is being advanced for partnering and feasibility studies with selected therapeutic candidates where non-invasive delivery may provide meaningful clinical, commercial, or formulation advantages.