Hoth Therapeutics has completed the manufacturing of its drug substance HT-KIT using good laboratory practice. 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 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.
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