Science & Product

The untapped potential of Fexofenadine

Our target portfolio is focused on exploring the untapped potential of Fexofenadine (FX). It comprises six drug concepts potentially covering up to 12 indications. 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. A proposed model for this property was presented in 2019. We suggest that the cPLA2 blocking ability of FX is an untapped resource that is likely to be dose-response dependent and manifested by means of DRPx strategies to achieve high focal concentrations in proximity to the pathological process.

With the high tolerability of FX our drug concepts are 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 as an untapped resource in clinical practice is just the start of our passion for DRPx innovation.
OP2101

FexoTopic - "Eczema Ease & Prevent"

FexoTopic (OP2101) is a lotion under development for treatment of mild and moderate Atopic Dermatitis, also called Eczema. It is envisaged as a short and long term "Eczema Ease & Prevent" monotherapy for adults and children from the age of 6 months. A main objective is to attain a pleasant skin-feel when applied to the sensitive skin of an atopic child. With FexoTopic we have taken a multi-pronged approach aimed at fast itch relief, inflammation control, suppression of bacterial imbalance, moisture retention, upregulation of antimicrobial peptides, and skin barrier restoration. In this strategy, FexoTopic targets the main pathological pillars of eczema.

The Atopic Dermatitis market is currently highly genericized, and no distinct trends in corporate strategy exist. However, over the coming decade the introduction of new drugs will emerge as a key future strategy for this marketplace. Unmet needs include the lack of therapeutic options, better long-term disease control and management, more tolerable topical treatment options, and improved patient treatment compliance. Children that comprises 75% of the patient group is known to be more vulnerable to adverse drug reactions, such as skin discomforts when treatments are applied. FexoTopic represents a significant opportunity to capture a share of this $5 billion-dollar annual market with a lotion that is tolerable, effective and economically attractive to payors.

OP2101

OP2102 - FexoTopic - Product summary

OP2101 - FexoTopic - Product page

OP2102 - FexoTopic - TPP 

Roadmap

Phase 1 (finalized):               Clinical Trials.gov
Phase 2A (funded):              Completion March 2023
Phase 2B (fund raise):         Q2 2023
Phase 2B:                             Q3 2023 --> complete Q3 2024
Phase 3 (fund raise):           Q4 2024
Phase 3 trial:                        Q1 2025 --> complete Q1 2026
MAA:                                     Q2 2026

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)

Feedback and endorsements

Mahesh Kandula
Founder - Cellix Bioscience
Mahesh Kandula (founder of Cellix Biosciences) - "I am looking forward to see FexoTopic brought to market. I am confident in the potential to bring value to children around the world suffering from Atopic Dermatitis. I am happy that OrchestratePharma is taking action to untrap the value of fexofenadine for this purpose".

Be part of the journey

Are you a patient, doctor, inventor or investor?
Follow us or join us on the journey.
Subscribe to our newsletter.

Contact us