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B3-OLX Product Briefs

Hyperpigmentation Product Brief

Team

B3 Owner - Akhila

OLX Lead - To Be Filled by Martha

Team - To Be Filled by Martha

Goal

Development of several Hyperpigmentation targeted products leveraging OLX proprietary molecule(s) with differentiated efficacy compared to existing non-prescription commercial products. Product should target all forms of hyperpigmentation (PIH, sun spots, melasma, erythema). Products include:

Facial Hyperpigmentation Treatment

Body Pigmentation Treatment

Requirements

Efficacy - Lighten hyperpigmentation including post-inflammatory hyperpigmentation, post-inflammatory erythema, age spots / dark spots, and melasma

Prescription level efficacy -

Comparable efficacy to hydroquinone (at effective concentrations of 4%+)

Greater efficacy than B3 commercial product that includes Symwhite (at effective concentration of 0.5%)

High specificity, should not cause visible skin bleaching in areas without dark spots

Non-negative impact on post-inflammatory erythema

Tolerability -

Suitable for 2x daily use

Tolerable for sensitive skin -

Less side effects profile than Hydroquinone

Comparable or less side effects profile of Symwhite

Formulation Constraints - Ability to be formulated with:

Salicylic Acid - Support future hybrid Acne + Hyperpigmentation products

Formulated with SymWhite

Kojic Acid - Recognizability for Hyperpigmentation claims

NOTE: Kojic acid is only included at marketing concentrations, so likely not a significant concern in terms of formulation

3-O-ethyl ascorbic acid - Antioxidant that aids in erythema

Brief Guidelines - Facial Hyperpigmentation Treatment

Benefits

Lighten hyperpigmentation – including dark spots, erythema, and sun damage

Improve skin appearance by reducing uneven skin tone

Gentle enough for daily use, even on sensitive skin, with hydrating / soothing ingredients to mitigate irritation

Form Factor -

Gel cream

Fill Size & Cadence

30ml, 2 month cadence

Experience

Light and absorbs quickly

Leaves skin feeling glowing

Seamlessly layers with other skincare products or under makeup (no piling)

Does not burn the eyes

Scent

TBD - Light fragrant refreshing smell

Claims Oil-free (Synthetic oils, plant oils, lanolin, mineral oils), Paraben-free, Cruelty-free, Alcohol-free (Ethyl alcohol), Non-comedogenic, Fragrance-free, Sulfate-free, Silicone-free, Phthalate-free, Synthetic dye-free, Prop-65 compliant, Formaldehydes-free

Ingredients Develop 3 different versions with a combination of melanin-target, antioxidant, exfoliating, multi-purpose, and hydrating ingredients:

Ingredient Specifications

Ingredient Specifications

Melanin-targeting

Antioxidant

Exfoliating

Multi-purpose

Hydrating

Symwhite 377 (0.5%) + Kojic Acid (MC*)

3-O-ethyl ascorbic acid (1%)

None

Niacinamide (4%) - Low-nicotinic acid

Allantoin Glycerin Hyaluronic Acid

Symwhite 377 (0.5%) + Kojic Acid (MC*)

3-O-ethyl ascorbic acid (1%)

Glycolic acid (0.3-0.5%)

Niacinamide (4%) - Low-nicotinic acid

Allantoin Glycerin Hyaluronic Acid

18-β Glycyrrhetinic Acid Phytosome (3%) + Kojic Acid (MC*)

3-O-ethyl ascorbic acid (1%)

None

Niacinamide (4%) - Low-nicotinic acid

Allantoin Glycerin Hyaluronic Acid

There are no rows in this table

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MC* denotes that ingredient is formulated at marketing concentration

Implementation Plan

Anti-Grey Pigmentation (Melanocyte Killing Molecule)

Goal - Identify highly-specific and broadly safe molecule that can effectively induce melanocyte cell death to reduce hyperpigmentation

Requirements -

Comparable efficacy to Hydroquinone and greater efficacy compared to SymWhite OR significant marginal efficacy when formulated in combination with SymWhite

High capacity to kill melanocytes (ideally via a known mechanism of cell death, e.g., caspase activation)

Highly specific for melanocytes (vs. other skin cells)

Minimally-sensitizing

Broadly non-toxic and non-immunogenicity

Formulation constraints - in addition to overall project formulation constraints, ability to be formulated with:

Symwhite - Highest efficacy on-the-market hyperpigmentation ingredient

Target Mechanism - Direct Melanocyte killing, induce apoptosis in melanocytes

Key Risks / Concerns

Efficacy Measurement -

B16 assay measurement certainty of direct melanocyte killing

Combination treatment improvement certainty over mono-treatment of SymWhite

New Molecule Discovery

Goal - Identify new molecule that can be used to tackle hyperpigmentation 3 main pathways

MC1R/MITF signaling pathway

Tyrosinase enzyme; all commercially available ingredients (Symwhite) all claim to inhibit tyrosinase (one of the targets for PhaseA)

TPC2ion channel

Milestones and Timeline to be filled by Martha

Timeline Key Constraints

OLX Hyperpigmentation

OLX Hyperpigmentation

Workstream

Owner

Start date

End date

Stage

Notes

Project

Ingredients Order

3. Efficacy

Melanocyte Killing

Cell Viability (Assay Creation)

3. Efficacy

Melanocyte Killing

Melanin Reduction Tests

3. Efficacy

Melanocyte Killing

Specificity Tests

4. Specificity

Melanocyte Killing

Safety Tests

5. Safety

Melanocyte Killing

Target Identification

1. R&D Research

New Molecule

Docking Targets

Dec 1

2. Computational

New Molecule

Ingredient Order

3. Efficacy

New Molecule

Cell Viability (Assay Creation)

3. Efficacy

New Molecule

Efficacy Tests

3. Efficacy

New Molecule

Stability & Compatibility Tests

5. Safety

New Molecule

Ingredients Scale / Ramp Up

6. Formulation

New Molecule

Formulation Development

6. Formulation

New Molecule

R1 Focus Groups

7. Focus Groups

New Molecule

There are no rows in this table

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Supporting Resources

Hyperpigmentation Research + Product Brief -

Link⁠

Direct Melanocyte Killing Update -

Link⁠

⁠

High Level Commercial Planning -

Link⁠

⁠

Hyperpigmentation Gantt -

Link⁠

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