株式會社 GEXVal
2024年7月1日 

GEXVal Completes Phase I Clinical Trial of GXV-001 in Australia

We are pleased to announce that GEXVal Inc. has successfully completed the Phase I clinical trial of our lead development program, GXV-001, in Australia through our wholly-owned subsidiary GEXVal AU Pty. Ltd.  We have received the Clinical Trial Summary Report.

The study, entitled “A Three-Part, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GXV-001 in Healthy Volunteers” (ACTRN12622000743763), aimed to investigate the target engagement* and pharmacological activity of GXV-001 in healthy young adults and elderly subjects.

Upon completion of the single ascending dose study (Part A, 5 doses), the top three doses were selected for further evaluation in a multi ascending dose study (Part B). An additional cohort of elderly subjects was included in Part C. The safety, tolerability, and pharmacokinetic profiles were confirmed at all doses. Notably, we achieved Proof of Mechanism (POM**), demonstrated through multiple biomarkers, including molecular biomarkers and whole-body physiological response.

Dr. Takashi Arima, Head of the Clinical Development Unit, commented, "We are pleased that we have reached this significant milestone for GXV-001, as we now progress toward Phase II studies in patients."

*Target Engagement: Capturing the drug's intended target molecule and exerting its pharmacological action.
**Proof of Mechanism (POM): Verification of how a drug exerts its pharmacological action on its intended target molecule and elicits a physiological response in clinical trials.

有關本事宜請諮詢:
Head of Corporate office
Atsushi Sugizaki
info@gexval.com