April 12, 2021
Hoth Therapeutics, Inc. is a patient-focused biopharmaceutical company, together with its manufacturing partner, today announced it has successfully completed the formulation for HT-001, a treatment for cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR inhibitor therapies.
HT-001 is expected to start its Phase 2a trial in pending approval of the IND submission. The finalization of the HT-001 formulation will allow the company to begin IND-enabling toxicology studies and manufacturing of clinical batches for the planned Phase 2a clinical trial.
The HT-001 formulation was developed in conjunction with Scientific Advisor Board Members, Dr. Jonathan Zippin, Dr. Adam Friedman, and Dr. Mario Lacouture, to ensure patient-focused attributes were key inputs of the formulation development. The HT-001 formulation includes a proprietary excipient blend to promote a protective skin barrier function after application. Preliminary data has shown effective skin protection up to 24hours after application based on a transepidermal water loss test model. In vitro permeation testing using human skin has also shown high Active Pharmaceutical Ingredients (API) permeation and retention after application of the selected HT-001 formulation.
“Working with our manufacturing partner, we have been able to successfully optimize the HT-001 formulation for topical application by patients while ensuring API solubility and stability,” said Dr. Stefanie Johns, Chief Scientific Officer at Hoth. “We believe this formulation will not only facilitate positive responses in the target areas of toxicity, but also provide the skin protection needed to potentially make patients more comfortable during EGFR inhibitor therapy.”
Hoth Therapeutics will now focus on completing the required regulatory studies for HT-001.