PIPELINE OVERVIEW
Novel OTC skin care products for certain skin conditions
With a holistic focus on patient care, we develop OTC skincare products specifically designed to complement medical treatments and provide soothing relief for dry, itchy skin caused by inflammation. Currently product candidates are designed to provide soothing relief for dry, itchy skin associated with certain skin conditions. Currently product candidates are designed to provide soothing relief for the dry and itchy skin associated with exposure to urea and filaggrin deficiency:
- Urea associated skin conditions include chronic kidney disease associated pruritus (CKD-aP), vulvar lichen sclerosus (“VLS”) and incontinence-associated dermatitis (“IAD”).
- Filaggrin deficiency associated skin conditions related to (i) inflammatory skin conditions such as atopic dermatitis, psoriasis and Sjögren or (ii) genetic deficiency of filaggrin.
We have established GMP manufacturing and conducted Ph2 POC clinical trials of prototype products in patients with CKD-aP (n=112) and vulvar lichen sclerosus (n=32). The compelling results are fueling our engagement in advancing optimized OTC skin care products into commercialization under the brand name “biomee™”.
Biomee™ skin care products are uniquely formulated using our proprietary PAD Technology™ enabling a new class of cream with the following key features:
- Reduced wash-off effect: PAD Technology™ enables creams with unprecedented low levels (<0.6%) of emulsifiers (soap like properties), minimizing wash-off of the skin’s natural microbiome and protecting lipid barrier, thereby reducing the risk of hypersensitive reactions. Conventional creams often contain over 5% emulsifiers, which can trigger irritation in sensitive skin.
- High tolerability: The ingredients used in biomee™ products are biotech-derived i.e. they serve a clinical meaningful purpose and are added in relevant amounts, ensuring high standards of purity and effectiveness.
- Luxurious Sensory Experience: PAD™ cream offers a luxurious, silky feel and is quickly absorbed into the skin, making it ideal for busy daily routines without leaving a greasy residue. No use of greasy wax or petrolatum.
- FDA Approved Delivery System: PAD Technology™ is used in FDA and EMEA-approved drug Wynzora® Cream, demonstrating its efficacy and safety in delivering delicate active ingredients to target tissue.
- Physical Stability: The PAD Technology™ enables very robust oil droplets and formulations, enabling a broader formulation space for stability of formulations and solubility of ingredients thereby optimising delivery into the skin.
- Eco-Friendly GMP Manufacturing: PAD™ creams are GMP manufactured at room temperature, significantly reducing the climate footprint compared to conventional high-temperature processes.