[Edaily Reporter KIM SAE-MI ] Sanofi’s atopic dermatitis treatment “Dupixent” (active ingredient: dupilumab), which utilizes Alteogen Inc.(196170)’s subcutaneous (SC) formulation modification platform “Hybrozyme,” is set to enter Phase 3 clinical trials.

According to the U.S. clinical trial registry ClinicalTrials.gov on the 6th, Sanofi registered a Phase 3 clinical trial (EXTENSA) to evaluate a formulation combining dupilumab with Alteogen Inc.’s human hyaluronidase “ALT-B4” (verahyaluronidase).

This trial is scheduled to enroll 150 patients aged 12 and older with moderate-to-severe atopic dermatitis. The objective is to compare the pharmacokinetics, immunogenicity, safety, and tolerability of the existing dupilumab formulation with the formulation containing ALT-B4.

The primary endpoint is the trough plasma concentration (Ctrough) immediately prior to drug administration. This will be used to evaluate whether the formulation containing ALT-B4 maintains an appropriate level of drug exposure compared to the existing formulation.

According to the clinical trial registration information, the study is scheduled to begin on the 30th. The EXTENSA trial is designed to include 20 weeks of treatment followed by 12 weeks of follow-up. The estimated date for analyzing the primary endpoint is May 2, 2028, and the study is expected to conclude on July 25 of the same year.

The launch of this Phase 3 clinical trial is significant in that it marks progress in the development of Alteogen Inc.’s Hybrozyme platform for application to global blockbuster drugs. However, since Dupixent is already administered via subcutaneous (SC) injection, this development differs from a typical formulation change—such as switching from intravenous (IV) to subcutaneous (SC) administration.

Previously, in June, Sanofi initiated a Phase 1 clinical trial involving 40 healthy adults to evaluate the pharmacokinetics and tolerability of a Dupixent formulation incorporating ALT-B4. That trial was completed on September 30. With the enrollment for this Phase 3 clinical trial, the scope of development has expanded from a single-dose evaluation in healthy subjects to a repeated-dose evaluation in actual patients with atopic dermatitis.

Meanwhile, Alteogen Inc. signed a non-exclusive technology transfer agreement with Sanofi for ALT-B4 in 2019. At the time, the deal was reported to be worth up to $1.37 billion (approximately 1.619 trillion won). As Sanofi begins full-scale development of an ALT-B4 formulation for Dupixent, attention is turning to the potential for receiving milestone payments based on future development milestones and the possibility of commercialization.