HanAll Biopharma (KRX: 009420.KS) today announced that, regarding the follow-up Phase 3 clinical trial plan for HL036, a novel, topical anti-TNF biologic that is being jointly developed with Daewoong Pharmaceutical, it had received a written response from the FDA of the U.S. that the plan is “acceptable”.
FDA stated through the written response that “conducting sign trial (VELOS-3) and symptom trial (VELOS-4) separately for different patient groups” and “setting the center corneal staining score (CCSS) and the eye dryness score (EDS) as primary endpoints for VELOS-3 and VELOS-4 respectively” are both acceptable.
The FDA’s response had been expected in light of the Draft Guidance on the development of dry eye drugs that the FDA CDER (Center for Drug Evaluation and Research) released in December of last year.
In relation to this, a HanAll Biopharma official stated, “To obtain a permit for HL036 in the U.S., we will need to repetitively show the sign and symptom efficacy for which significance was verified through the first Phase 3 clinical trial, VELOS-2, by setting them as primary endpoints for two separate trials so as to meet the requirement to verify reproducibility of the drug effect and the pre-specified endpoints at least once.”
HanAll Biopharma is currently working on the production technology transfer and scale-up on the premise of commercial production through a contract with CMO of the U.S. It plans to complete the clinical sample manufacturing during the first half of this year and to commence the Phase 3 clinical trial in the second half.