Kringle Pharma, Inc. ((JP:4884)) announced an update on their ongoing clinical study.
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Kringle Pharma, Inc. is conducting a Phase 3 clinical study titled ‘A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar.’ The study aims to confirm the efficacy and safety of KP-100LI, a treatment designed to improve voice function in patients with vocal fold scars.
The intervention being tested is KP-100LI, an intracordal injection containing recombinant human dHGF, administered weekly for three weeks. This treatment aims to enhance voice function in affected patients.
The study is interventional, with participants randomly allocated to either the KP-100LI or placebo group. It follows a parallel model with triple masking, meaning participants, investigators, and outcomes assessors are unaware of group assignments. The primary goal is treatment efficacy.
The study began on November 16, 2022, with an estimated completion date of June 11, 2025. These dates are crucial for tracking the study’s progress and potential market entry of the treatment.
This study update could influence Kringle Pharma’s stock performance positively if results show significant efficacy, potentially boosting investor confidence. The competitive landscape includes other companies developing treatments for vocal fold conditions.
The study is currently recruiting, with further details available on the ClinicalTrials portal.