NEWS
Tharimmune Announces Positive Type C Meeting with FDA for Phase 2 Program for TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Primary Biliary Cholangitis
Tharimmune has received positive feedback from the FDA for its Phase 2 clinical trial of TH104, a transmucosal buccal film containing nalmefene, for treating moderate-to-severe pruritus in primary biliary cholangitis (PBC). This feedback supports Tharimmune's plan to pursue a 505(b)(2) approval pathway, allowing the use of existing data on the approved active ingredient. The FDA acknowledged that the nonclinical studies are adequate for Phase 2 trial initiation and provided recommendations on study design, patient inclusion, primary endpoints, and monitoring for adverse events. Tharimmune aims to start the trial in late 2024.
Positive
Positive FDA feedback supports Phase 2 trial initiation.
FDA supports 505(b)(2) pathway, allowing use of existing data on nalmefene.
Nonclinical studies deemed sufficient for Phase 2 by FDA.
FDA provided detailed recommendations on study design and patient monitoring.
Company plans to start the Phase 2 trial in late 2024.
Negative
No specific negative points were directly highlighted in the PR.
Positive
Positive FDA feedback supports Phase 2 trial initiation.
FDA supports 505(b)(2) pathway, allowing use of existing data on nalmefene.
Nonclinical studies deemed sufficient for Phase 2 by FDA.
FDA provided detailed recommendations on study design and patient monitoring.
Company plans to start the Phase 2 trial in late 2024.
Negative
No specific negative points were directly highlighted in the PR.
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
Spread kindness and love. Life is short. Don’t let greed eat you.
1681Followers
93Following
13KVisitors
Follow