Skip to content
Home » FunPep Co., Ltd. Announcement of additional phase III clinical trial of functional peptide “SR-0379” ~ Con firmation of efficacy in specific patient population ~

FunPep Co., Ltd. Announcement of additional phase III clinical trial of functional peptide “SR-0379” ~ Con firmation of efficacy in specific patient population ~

[FunPep Co., Ltd.] Announcement of additional phase III clinical trial of functional peptide “SR-0379” ~ Confirmation of efficacy in specific patient population ~
*Fun Pep Co., Ltd.*
Press release: July 5, 2024
**
Announcement of additional phase III clinical trial of functional peptide “SR-0379” ~Confirmation of efficacy in specific patient population~

Fun Pep Co., Ltd. Logo
* FunPep Co., Ltd. (Head office: Ibaraki City, Osaka Prefecture, Representative Director and President: Miyoshi
Minoru (Toshimi) has been conducting a Phase III clinical trial (Study SR0379-JP-SU-01, hereinafter referred to as “Study 01”) from June 2021 on the functional peptide “SR-0379,” which is currently being developed for skin ulcers. Based on the results, an additional phase III clinical trial (Study SR0379-JP-SU-02, hereinafter referred to as “Study SR0379-JP-SU-02”) aimed at early approval (to confirm the reproducibility of the efficacy of Study 01) was conducted. We would like to inform you that we have decided to conduct the 02 Examination. The 02 exam is scheduled to start in the first quarter of 2025. *

Bacterial and infection control is important for the treatment of skin ulcers, where the skin’s barrier function is deficient and various bacteria adhere to the wound surface. SR-0379’s strength is that it not only promotes wound healing by promoting angiogenesis and granulation formation, but also has antibacterial activity. Through the development of SR-0379, we aim to promote the early recovery of skin ulcers such as pressure ulcers and diabetic ulcers, which are becoming increasingly important in an aging society, and to contribute to improving the quality of life of patients. Masu. Our company is currently conducting joint development with Shionogi & Co., Ltd. in Japan.

Study 01 was a multicenter, double-blind comparative study in which 126 patients with skin ulcers were assigned to the SR-0379 group or the placebo group (1:1), and the study drug was administered once a day for 28 days. I did.

As a result, although there was no statistically significant difference between the SR-0379 group and the placebo group regarding the primary endpoint, “days leading up to surgical treatment,” approximately 80% of cases (101 Post hoc subgroup analysis (ulcer size (longer axis x shorter axis) 36 cases)
cm2), the median time to surgical treatment was approximately 5 days shorter with 22.0 days in the SR-0379 group and 27.0 days in the placebo group, with a statistically significant difference in the SR-0379 group compared to the placebo group. was confirmed (p=0.0270 (generalized Wilcoxon test)). Regarding safety, there were no adverse events causally related to the investigational drug, confirming the high safety of SR-0379.
The company plans to conduct Study 02 to confirm the reproducibility of the efficacy in patients with skin ulcers (ulcer size (longer axis x shorter axis) less than 36 cm2) for whom efficacy was observed in Study 01 above.

The “skin ulcers that require surgical treatment such as skin grafting” that patients in Study 01 have are deep skin defects, and the condition of the wound bed is improved by promoting the formation of benign granulation, which is skin regeneration tissue. It is important to improve the skin ulcer as soon as possible to a state where skin grafts, etc. can be taken.

Negative pressure wound therapy*, which promotes early granulation formation, is actively used for relatively large skin ulcers, but its effectiveness was confirmed in a post-hoc subgroup analysis of Study 01, and it was included in Study 02. For relatively small skin ulcers, the application of negative pressure wound therapy is limited due to device specifications and the operator/handling environment, creating an unmet medical need.
The Company will conduct Study 02 with the aim of early approval of SR-0379 as a new treatment option for skin ulcers that meets this medical need.
*Negative Pressure Wound Therapy (NPWT)
Therapy) is a method of wound management by covering the entire wound surface with an occlusive dressing to maintain a negative pressure closed environment.
*About details about this release*
https://prtimes.jp/main/html/rd/p/000000003.000142282.html

*Download press release materials*
https://prtimes.jp/im/action.php?run=html&page=releaseimage&company_id=142282&release_id=3


Unsubscribe HTML email

Copyright © PR TIMES Corporation All Rights Reserved.