Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA‘s SNY Phase 3 LIBERTY-CUPID Study C of Dupixent (dupilumab) was successful.

The study met the primary and key secondary endpoints for uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.

CSU is a chronic skin condition that causes hives and persistent itch. The positive trial confirms results from Study A, the first Phase 3 trial of Dupixent in this setting.

Also Read: Regeneron Pharmaceuticals’ Q2 Earnings Exceed Estimates, Driven By Its Top-Selling Eczema And Eye Drugs.

Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.

At 24 weeks, efficacy among patients receiving Dupixent compared to placebo was as follows:

• 8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point reduction with placebo.
• Dupixent reduced the severity of urticaria activity (itch and hive) by 15.86 points from baseline compared to 11.21 points with placebo.
• 30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of placebo patients.

Detailed results from this trial will be provided to the FDA by year-end 2024 in response to the additional data requested for inclusion in the supplemental biologics license application for Dupixent in CSU after rejection in October 2023.

Concurrently, Regeneron Pharmaceuticals and Sanofi announced that a Dupixent (dupilumab) ADEPT Phase 2/3 trial in bullous pemphigoid met the primary and all key secondary endpoints.

Five times more Dupixent patients achieved sustained disease remission in the trial than placebo patients.

For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to 4% for placebo (p=0.0114).

Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period.

For the components comprising the primary endpoint – with patients having to achieve all components – efficacy among patients receiving Dupixent compared to placebo was as follows:

• The absence of disease relapse after the patient completed the OCS taper was 59% vs. 16%.
• Absence of need for rescue therapy during the treatment period: 42% vs. 12%.
• Achievement of complete remission and off OCS by week 16: 38% vs. 27% (not significant).

Additionally, a small separate Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin did not achieve statistical significance in its primary itch responder endpoint but showed nominally significant improvements in all other itch endpoints.

The Dupixent Phase 3 program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal trial.

Price Action: REGN stock closed at $1,136.35, and SNY stock closed at $58.08 on Tuesday.

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