Science & Product

Atopic Dermatitis

Celfex is a topical lotion currently in Phase 2 clinical development for treatment of mild and moderate Atopic Dermatitis, also called Eczema.  
Celfex is targeted for short and long term eczema monotherapy (‘soothe & prevent’ for children (6 months) to adults. Celfex is a topical lotion formulated with fexofenadine, a drug known for its antihistamine properties. It has recently been shown to have new anti-inflammatory actions. It modulates key inflammatory mediators IL-1β, IL-4, IL-5, IL-13, IL-31, and IFNγ.
Celfex is aimed at itch relief, inflammation control, suppression of bacterial imbalance, moisture retention, upregulation of antimicrobial peptides, and skin barrier restoration. In this strategy, Celfex targets the main pathological pillars of eczema.

Atopic Dermatitis market is growing globally and there is demand for cost effective and efficacious solutions.  
Unmet needs include:  patient therapy compliance, a shortfall of therapeutic options, improved long-term disease control, and few tolerable topical treatment options. Children are 75% of the target population group – they tend to be more vulnerable to adverse drug reactions such as skin discomfort. Celfex represents a significant opportunity to capture a share of this multi billion-dollar global market.  Celfex lotion is targeting to be tolerable, effective and lower cost.

Our licensed IP is a granted patent

Celfex

The untapped potential of Fexofenadine

Fexofenadine (FX) to date has been delivered in oral form.  
With this patent we have for the first time achieved a stable formulation of Fexofendine for topical application – we have named this Celfex.  
FX has a high therapeutic index and a safety profile close to placebo even at doses up to four times the prescribed. The antihistamine (H1R antagonist) property of FX is well documented, and we are currently exploring how it can be leveraged in a dose-response dependent way in diseases characterized by itching (pruritus).

Our FX drug concepts also explore how the recently identified anti-inflammatory properties of FX can be manifested in clinical practice. FX has been described to reduce the levels of TNF-α by blocking the cPLA2 pathway. In 2019 it was suggested that the cPLA2 blocking ability of FX is an untapped resource that is likely to be dose-response dependent.  

With the high tolerability of FX, this drug is well suited for targeting unmet medical needs in sensitive patient groups, such as children, the elderly, and renally or hepatically impaired. The exploration of Fexofenadine in AD (Celfex) could be just the first of many other potential uses

Celfex

Roadmap

Phase 1 (finalized):   Clinical Trials.gov
Phase 2A/B (India):  Initiated – Plan completion Q1/26
Phase 2A/B: (Eur):   Planning – target complete 2026
Phase 3 & MAA:       Target 2027

01.

“Itch-scratch cycle” interruption by H1R blocking (FX)

02.

Long-term safe, anti-inflammatory (flare) control (FX)

03.

Dysbiosis control and antimicrobial efficacy on S. Aureus (Hexylene Glycol) [34]

04.

Moisture retention (Dexpanthenol, Petrolatum and Hexylene Glycol)

05.

Barrier repair (Dexpanthenol and Petrolatum) [43]

06.

Upregulation of antimicrobial peptides, lipocalin and beta-defensin 2 (Petrolatum)

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