Raphas Re-files IND for Phase 2b/3 Trial of Allergic Rhinitis Immunotherapy DF19001 Due to Administrative Procedure Change
Raphas submitted a correction disclosure on 2026-05-28 regarding its IND submission for the phase 2b/3 clinical trial of allergic rhinitis immunotherapy DF19001.
The correction pertains to an administrative change: the filing was re-submitted as an amendment to the existing IND per MFDS guidelines, shifting the application date and confirmation date from 2026-05-22 to 2026-05-28.
The trial is a multicenter, randomized, double-blind, placebo-controlled phase 2b/3 study evaluating the efficacy and safety of DF19001 over 52 weeks in 336 patients (3 arms, 112 each) with American house dust mite allergic rhinitis.
After the phase 2b portion, an IDMC will conduct an unblinded interim analysis to recalculate the phase 3 sample size, with continuous enrollment. Total trial duration is approximately 52 months from IRB approval.
The trial will be conducted at Severance Hospital, with the primary endpoint being the average daily combined symptom-medication score for rhinitis.
Risk factors include a statistical approval probability of only about 10% for investigational drugs, and potential changes or abandonment of commercialization plans.
[AI Comprehensive Analysis]This correction is purely administrative with no change to the trial plan or progress, thus having limited short-term stock impact. While the advancement to phase 2b/3 is positive for the pipeline's long-term value, the low statistical success rate and long trial duration (approx. 52 months) should be considered as investment risks.
KOSDAQ Filing Information
Filing: [Correction of Description] Major Management Matters Related to Investment Decision (Application for Clinical Trial Plan Approval) (Application for Approval of Clinical Trial Plan (IND) for Allergic Rhinitis Immunotherapy DF19001 Phase 2b/3)