HOTH THERAPEUTICS, INC. Hoth Therapeutics, Inc. announced it has completed the manufacturing of its drug substance HT-KIT using good laboratory practice (GLP). HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). Hoth also recently completed its Pre-IND meeting with FDA in November.
Hoth has now successfully completed manufacturing of the HT-KIT drug substance in collaboration with WuXi STA Pharmaceutical. Hoth plans to use the GLP drug substance in its upcoming pre-clinical studies required for its investigational new drug (IND) submission.
