BioNews| Hoth: Cooperate with Camargo to apply for HT-001 IND

Hoth Therapeutics, Inc. (HOTH) announced that it has entered into an agreement with Camargo PharmaticalServices to collaborate on the preparation of an investigational new drug application (IND) for HT-001 to be submitted to the U.S. Food and Drug Administration (FDA) to initiate the first clinical trial.

Camargo collaborates with emerging biopharmaceutical companies to address unmet medical needs in rare and complex regions by optimizing patient paths.  The Company will be responsible for the preparation, preparation and submission of an IND to the FDA.Based on FDA feedback on HT-001, the decision to initiate IND was made based on responses to the Pre-IND meeting (expected February 22, 2021) and the ongoing GLP toxicology study.

HT-001 is a topical formulation for the treatment of patients with mild to moderate rashes and skin diseases associated with initial and repeated courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy.EGFR inhibitors are used to treat cancers that are EGFR upregulated (such as non-small cell lung cancer, pancreatic cancer, breast cancer, and colon cancer).  EGFR inhibitors are usually associated with dose-limiting skin toxicity, which can lead to treatment interruption. HT-001 targets the treatment of these EGFR-induced skin diseases, so that patients can obtain the best potential effect of EGFR treatment.

Currently in preclinical development of HT-001, the product is being submitted to the NDA through the 505(b)(2) development pathway, in which HothTherapeutics intends to obtain information non-through Rightof Reference in order to reduce non-clinical and clinical schedules and speed up NDA submission time.