WCC Biomedical's Microneedle New Drug Wins FDA IND Clearance
核心洞察
WCC Biomedical (搜索) said on September 15 that the FDA has cleared an IND for its microneedle drug candidate WCC301 (搜索), allowing a combined Phase 1/2a trial to begin.
WCC301 (搜索) is being developed under the 505(b)(2) pathway for localized pain associated with acute ankle sprains and uses a 1.5 cm patch worn for five minutes.
In miniature pigs, the patch reached peak plasma concentration within 15 minutes, with absolute bioavailability of 35% to 43% and dose-proportional AUC.
WCC Biomedical (搜索), a Taiwanese developer of microneedle drug delivery technologies, announced on September 15 that its lead candidate WCC301 (搜索) has received Investigational New Drug clearance from the U.S. Food and Drug Administration (搜索). The clearance allows the company to start a combined Phase 1/2a clinical trial. WCC301 is being developed for localized pain associated with acute ankle sprains and follows the FDA's 505(b)(2) regulatory pathway.
The candidate is a transdermal drug delivery system designed to deliver medication directly to the treatment area. Its patch is a compact circular design measuring 1.5 centimeters in diameter, roughly one-fiftieth the size of a conventional pain-relief patch, and is worn for five minutes before removal, with a cooling design intended to limit skin discomfort. In a single-dose pharmacokinetic study in miniature pigs, WCC301 (搜索) reached peak plasma concentration within 15 minutes, AUC increased proportionally with dose, and absolute bioavailability ranged from 35% to 43%.
WCC Biomedical (搜索) has developed the WINMAP platform to address microneedle scale-up, combining its Microneedle Material and Formulation Database, Precision Loading and Coating technology, and an Automatic Mass Production system built for PIC/S GMP manufacturing. The company says one production line can reach annual capacity of up to 10 million patches with yields above 95%, and that inter-batch variation in drug loading and microneedle geometry can be controlled within 3%. A patented mini device separates microneedle array formation from drug loading, allowing APIs to be coated onto Hydrogel Microarray Patches in about 30 minutes. After the FDA clearance, the company plans to file a clinical trial application with the Taiwan Food and Drug Administration (搜索), and it intends to extend the platform to Enterovirus 71 (搜索) and mRNA vaccines while pursuing out-licensing and CDMO partnerships.
Source: GeneOnline