Biolexa (gentamicin/diethylenetriaminepentaacetic acid) / Chelexa BioSci, Hoth Therap - LARVOL DELTA

Hoth Therapeutics Announces Positive Final Results from 14-day Phase 1b Clinical Trial of BioLexa (PRNewswire) - "P1b | N=31 | NCT04544943 | Sponsor: Hoth Therapeutics, Inc. | "Hoth Therapeutics, Inc...announced that it has completed its analysis of the data from its Phase 1b clinical trial of BioLexa as a therapeutic for atopic dermatitis....Treatment with BioLexa over the 14-day treatment period led to a 35% improvement in SCORAD ('SCORing Atopic Dermatitis') measurement and a 60% improvement in EASI (Eczema Area and Severity Index) measurement of atopic skin disease, whereas gentamicin lotion and placebo had no effect. In addition, patient-reported DLQI (Dermatology Life Quality Index questionnaire) found that BioLexa use led to a 46% improvement in patient quality of life, whereas gentamicin lotion and placebo had no effect."

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Hoth Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2022 | Trial primary completion date: Jan 2022 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

"$HOTH enterprise value $8M extremely undervalued! The lead asset BioLexa technology could be valued billions! Only one indication Atopic dermatitis market opportunities $15-$20B! Currently in phase 1/2 readout 1Q2022 @Amgen $AMGN & @KyowaHakkoUSA should acquire/license Biolexa" (@ej23ny)

P1/2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Hoth Therapeutics Submits to Ethics Committee for Approval to Initiate Patient Cohort 2 in BioLexa Clinical Trial (Yahoo Finance) - “Hoth Therapeutics, Inc…announced today that a Safety Review Committee (SRC) has reviewed the safety data from the first cohort of healthy subjects and recommended that the study proceed to dosing patients with mild to moderate atopic dermatitis, also known as eczema. There were no serious adverse events and no drug-related treatment-emergent adverse events observed during the administration of BioLexa in healthy subjects. Based on the recommendations of the SRC, Hoth has submitted to the Human Research Ethics Committee (HREC) overseeing the trial to obtain official approval to proceed dosing the patient cohort. The official submission to HREC occurred on September 10, 2021.”

Trial status • Atopic Dermatitis • Dermatology • Immunology

"$HOTH developed BioLexa Platform non-corticosteroid approach for atopic dermatitis" (@ej23ny)

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Hoth Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1; N=34; Not yet recruiting; Sponsor: Hoth Therapeutics, Inc.; N=64 ➔ 34; Trial completion date: Jul 2022 ➔ Jan 2022; Initiation date: Oct 2020 ➔ Mar 2021; Trial primary completion date: Apr 2022 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology