Hoth Therapeutics, Inc., a biopharmaceutical company, 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 has received orphan drug designation from the U.S. FDA. Hoth also recently completed its Pre-IND meeting with the 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 preclinical studies required for its investigational new drug (IND) submission.

“With this important step now completed and with our Pre-IND responses from FDA, Hoth is now ready to plan its IND-enabling studies and pathway to HT-KIT’s first-in-human clinical trial,” said Robb Knie, CEO of Hoth.