02試験はプラセボ対照二重盲検比較試験であり、01試験で効果がみられた皮膚潰瘍患者(潰瘍サイズ(長径×短径)36センチ平方メートル未満、目標症例数:142例)を対象に、SR-0379又はプラセボを二重盲検下で1日1回、28日間投与した際の有効性及び安全性を検討する。FanPepp <4881> announced on the 23rd that the requisite investigation by the Pharmaceuticals and Medical Devices Agency (PMDA) has been completed for the functional peptide "SR-0379," which is being developed for the treatment of skin ulcers, and the Phase 2 trial will commence.
SR-0379 is a development compound of a functional peptide composed of 20 amino acids.
For the treatment of skin ulcers where the skin barrier function is compromised and various bacteria have adhered to the wound surface, controlling bacteria and infections is crucial. The strength of SR-0379 lies in its ability to promote wound healing through angiogenesis and granulation tissue formation, along with possessing antibacterial activity. Moreover, due to its simple administration method (a spray that can be stored at room temperature), it is expected to be used by a wide range of patients with skin ulcers.
The Phase 2 trial is a placebo-controlled double-blind comparative study, targeting patients with skin ulcers (ulcer size (long diameter × short diameter) less than 36 square centimeters, target sample size: 142 cases) who showed efficacy in the Phase 1 trial. It will investigate the effectiveness and safety of administering either SR-0379 or placebo once daily for 28 days under double-blind conditions.
The development of SR-0379 is currently being advanced in Japan through a joint development with Shionogi & Co., Ltd. <4507>.
