Hoth Therapeutics has shared phase 2 results on its treatment of EGFR inhibitor-induced skin toxicities, ticking off another milestone for a candidate designed to complement cancer therapies.
The open-label part of the midstage trial enrolled 12 patients to measure the pharmacokinetics of HT-001 gel. As a neurokinin 1 receptor agonist, HT-001 could have anti-inflammatory properties that mitigate skin side effects that cause some people taking EGFR inhibitors to pause treatment or lower their dose. A drug that prevents dose-limiting toxicities could improve outcomes.
Hoth is still some way from showing HT-001 is that drug, but it edged the program forward Thursday by sharing updated data. Across six weeks of treatment, scores on an acneiform rash scale fell from 1.67 to 0.83. All patients scored below one on the scale at Week 6, indicating low-severity disease. The result is in line with earlier cuts of the data shared by the biotech last year.
The ARIGA acneiform rash scale used as the primary endpoint is a novel measure. Hoth also shared data on the established patient-reported itch numerical rating scale, reporting that mean scores fell from 4.22 at baseline to 2.67 at Week 6.
Hoth ran the open-label study as a precursor to enrolling a randomized double-blind cohort comparing HT-001 to placebo. The double-blind trial was designed to enroll 140 people across three HT-001 doses and placebo. Hoth removed those study details and an R&D timeline from its investor slides when it updated the presentation this month.
Investors were unmoved by the data, barely budging the share price of a biotech with a sub-$20 million market cap. The company ended September with cash and cash equivalents of $7.8 million, a sum it said was sufficient to fund operations for at least the next 12 months.