皮膚のバリア機能が欠損して様々な細菌が創面に付着している皮膚潰瘍の治療には、細菌、感染のコントロールが重要である。SR-0379は、血管新生や肉芽形成促進による創傷治癒促進作用に加え、抗菌活性を併せ持つ点が強みとなっている。また、簡便な投与方法(常温保存可能なスプレー剤)であることから、幅広い皮膚潰瘍の患者に使用されることが期待される。Fanpep <4881> announced on the 9th that it submitted a clinical trial application for an additional phase 3 clinical trial (the SR0379-JP-SU-02 trial, hereinafter referred to as the 02 trial) to the Pharmaceuticals and Medical Devices Agency (PMDA) on December 6, aiming for early approval of the functional peptide "SR-0379" being developed for the treatment of skin ulcers.
Following the completion of the PMDA's prescribed investigation, the 02 trial is scheduled to commence.
SR-0379 is a developmental compound of a functional peptide composed of 20 amino acids.
In the treatment of skin ulcers where the skin barrier function is compromised and various bacteria adhere to the wound surface, controlling bacteria and infection is crucial. SR-0379 has the advantage of promoting wound healing through angiogenesis and granulation formation, while also possessing antibacterial activity. Additionally, it is expected to be used by a wide range of patients with skin ulcers due to its simple method of administration (a spray preparation that can be stored at room temperature).
Through the development of SR-0379, the aim is to promote early recovery from skin ulcers such as pressure sores and diabetic ulcers, which are becoming more important in an aging society, thereby contributing to the improvement of patients' quality of life (QoL).
The development of SR-0379 is currently being advanced in Japan through a joint development with Shionogi & Co., Ltd. <4507>.
