Rocket One Inc. (NASDAQ: RKTO) today announced that its biotechnology subsidiary, Hoth Therapeutics, has decided to end its Phase 2a clinical trial of HT-001 early following strong interim efficacy results. Hoth is preparing to seek U.S. Food and Drug Administration (FDA) feedback on advancing HT-001 into a potential Phase 3 clinical program.
HT-001 is an investigational topical formulation of aprepitant being developed to treat dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor cancer therapies. These skin complications can cause significant discomfort, affect patients' quality of life, and lead to interruptions or modifications of cancer treatment.
“Following review of the available interim efficacy and safety data,” to quote this morning’s news release, “Hoth determined that the findings support concluding Phase 2a early and pursuing regulatory discussions on the next stage of development.
"We are encouraged by the strength of the interim findings and believe they support taking the next step toward a potential Phase 3 program," said CEO Robb Knie. "Our goal is to help patients manage the skin toxicity associated with EGFR inhibitor therapy so they can better tolerate their cancer treatment. We are now focused on presenting the data to the FDA and establishing the requirements for the next stage of HT-001's development."
RKTO shares cleared breakeven 4.5 cents, or 10%, to 49.42 cents.
Related Stories
