aprepitant topical (HT-001) / Hoth Therap - LARVOL DELTA

Hoth Therapeutics Expands Intellectual Property Portfolio with Acquisition of New Patent Applications (PRNewswire) - "IP will be used to pursue further indications for HT-001 Cancer Therapeutic...Hoth Therapeutics, Inc...proudly announces advancements in its intellectual property portfolio through the acquisition and expansion of patent applications to its innovative therapeutic pipeline...These newly secured patents reflect Hoth's commitment to pioneering cutting-edge treatments that address unmet medical needs, with a focus on enhancing therapeutic efficacy and broadening applications across various disease areas."

Patent • Oncology

Hoth Therapeutics Achieves Breakthrough in Phase 2a Trial: HT-001 Delivers 100% Success in Combating Cancer Treatment Skin Toxicities (PRNewswire) - P2a | N=152 | CLEER (NCT05639933) | Sponsor: Hoth Therapeutics, Inc. | "Data from the open-label portion of the CLEER-001 trial demonstrated remarkable success: 100% of patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark; 66% of patients reported reduced pain and itching scores, further enhancing quality of life...Crucially, all patients maintained their full EGFRi dosage, preserving the cancer treatment's full therapeutic effect—a notable improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects....No treatment-related adverse effects have been reported, reaffirming HT-001's excellent tolerability."

P2a data • Oncology

CLEER: Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Hoth Therapeutics, Inc. | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Dermatology • EGFR

Hoth Therapeutics Announces Positive Data from First-of-its-Kind Human Patient Treatment of EGFRI-Associated Skin Toxicities with HT-001 (PRNewswire) - "Hoth Therapeutics, Inc...is excited to announce positive data from the treatment of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs) with its novel therapeutic HT-001...In the reported case, the patient, a 59-year-old female undergoing treatment at George Washington University for metastatic breast cancer, experienced significant improvement in symptoms just one week after initiating HT-001 therapy. Due to the swift resolution of lesions and the alleviation of discomfort, the patient was able to discontinue the treatment after just seven days. Over the following three weeks, no new lesions developed, further highlighting the potential of HT-001 as an effective and safe therapy for EGFRI-associated PPEs."

Clinical data • Dermatology

Hoth Therapeutics Expands Clinical Trial for Cancer Patients (PRNewswire) - "Hoth Therapeutics, Inc...announced that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi)....This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi."

Trial status • Oncology

CLEER: Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Hoth Therapeutics, Inc. | Phase classification: P2a ➔ P2

Phase classification • Dermatology • EGFR

Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients (PRNewswire) - P2a | N=152 | CLEER (NCT05639933) | Sponsor: Hoth Therapeutics, Inc. | "Hoth Therapeutics, Inc...announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which is being developed as a potential treatment for cancer patients undergoing treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI). The trial is being conducted under Hoth's open Investigational New Drug Application (IND) for HT-001....'We are extremely pleased to announce clearance of our clinical trial optimization plan for HT-001. Armed with positive initial data and a clean safety profile to date, we believe that these protocol amendments could ultimately result in the generation of a highly compelling data set which could support patients suffering from the effects of EGFRI cancer treatment.'"

Clinical protocol • FDA event • P2a data • Dermatology

Hoth Therapeutics Announces Expansion of FDA Cleared First-In-Human Clinical Trial For Cancer Patients of HT-001 at University of Miami (PRNewswire) - "Hoth Therapeutics, Inc...announced today that it has received approval from the University of Miami to enroll patients for its first in human clinical trial of HT-001. This First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi). This clinical trial is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi."

Trial status • Dermatology

CLEER: Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors (clinicaltrials.gov) - P2a | N=152 | Recruiting | Sponsor: Hoth Therapeutics, Inc. | Initiation date: Feb 2023 ➔ Jul 2023

Trial initiation date • Dermatology

Hoth Therapeutics Announces Major Milestone of First Patient Dosed in Phase 2a Clinical Trial (PRNewswire) - "Hoth Therapeutics, Inc...today announced today that the first patient has been dosed in its Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi)....This clinical trial is a randomized, placebo-controlled, parallel Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi."

Trial status • Dermatology

Hoth Therapeutics Receives Protocol Approval for HT-001 Cancer Therapeutic (PRNewswire) - "Hoth Therapeutics, Inc...today announced that it has received approval from the Food & Drug Administration ('FDA') for a protocol change in its Phase 2a clinical trial of HT-001. Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash and other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life. The study will be completed in 2 parts: the first part is an open-label (unblinded) cohort and all patients will receive HT-001 topical gel with the active ingredient; the second part is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Hoth will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect."

FDA event • Dermatology

Hoth Therapeutics Announces Collaboration with First Active Clinical Site for its Phase 2 Trial to Treat Cancer Disorders Associated with Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy (PRNewswire) - "Hoth Therapeutics...today announced the activation of Washington University School of Medicine in St. Louis as the first clinical site in the CLEER-001 Phase 2a clinical trial of HT-001 for the treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy."

Trial status • Dermatology

CLEER: Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors (clinicaltrials.gov) - P2a | N=152 | Recruiting | Sponsor: Hoth Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology

CLEER: Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors (clinicaltrials.gov) - P2a | N=152 | Not yet recruiting | Sponsor: Hoth Therapeutics, Inc.

New P2a trial • Dermatology

Hoth Therapeutics Announces the selection of NUVISAN for Manufacturing HT-001 Drug Batches for CLEER-001 Clinical Study for Cancer Patients (PRNewswire) - "Hoth Therapeutics, Inc...announced it has signed an agreement with NUVISAN, a European CRO/CDMO with topical manufacturing capabilities in Sophia-Antipolis, France, to manufacture clinical batches of HT-001 topical drug product for its upcoming CLEER-001 clinical trial for cancer patients....The CLEER-001 clinical trial is a randomized, placebo-controlled, phase 2a dose-ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFR inhibitors. The study is planned to include 14 clinical sites in the United States."

Licensing / partnership • New P2a trial • Oncology

Hoth Therapeutics Announces Participation at the American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - " Hoth Therapeutics, Inc...announced...that it will be an exhibitor at the American Society of Clinical Oncology (ASCO) Annual Meeting. Attendees will be able to visit the Hoth Therapeutics booth virtually starting May 24th through July 6, 2021. Hoth Therapeutics is dedicated to helping address unmet medical needs and improve the quality of life for patients living with rare cancers through the development of its assets, HT-001 and HT-KIT."

Clinical • Oncology

Hoth Therapeutics Completes HT-001 Formulation Development for Upcoming Cancer Patient Clinical Trial (PRNewswire) - "...Hoth Therapeutics, Inc...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....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."

Clinical • New P2a trial • Preclinical • Oncology

Hoth Therapeutics Engages Worldwide Clinical Trials as Contract Research Organization for Phase 2a HT-001 Clinical Trial for Cancer Patients (PRNewswire) - "Hoth Therapeutics, Inc...announced that it has engaged Worldwide Clinical Trials ('Worldwide'), a full-service Contract Research Organization ('CRO') for its upcoming Phase 2a dose ranging clinical trial of HT-001 for treatment of cutaneous toxicities associated with EGFR inhibitor therapy for cancer patients....Hoth's Phase 2a dose ranging clinical trial will investigate the efficacy and safety of varying dose strengths of HT-001 in comparison to placebo for treatment of cutaneous disorders (skin, nails, and scalp) associated with EGFR inhibitor therapy."

Clinical • Oncology

Hoth Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA Regarding Proposed Development of HT-001 For Cancer Patients (PRNewswire) - "Hoth Therapeutics, Inc...announced...the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The Pre-IND meeting was completed through written responses provided by the FDA Division of Dermatology and Dentistry on February 22, 2021...Based on the FDA's feedback, Hoth intends to advance its IND-enabling activities for HT-001 as planned...No significant changes to the planned IND-enabling toxicology program for the planned phase 2a study....'The positive feedback from the FDA is a significant milestone for Hoth in executing our clinical development program for HT-001 in treating cancer patients suffering from dermatological ailments during EGFR inhibitor treatment.'"

FDA event • Dermatology • Oncology

Hoth Therapeutics to Initiate IND Enabling Studies of HT-001 Treatment for Cancer Patients (PRNewswire) - "Hoth Therapeutics, Inc...announced an agreement with Charles River Laboratories to initiate preclinical studies of HT-001, a topical formulation designed for the treatment of patients with rash and skin disorders associated with initial and repeat EGFR inhibitor cancer treatment."

Licensing / partnership • Oncology

Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients (PRNewswire) - "Hoth Therapeutics, In...announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy...Hoth Therapeutics anticipates a meeting with the FDA to be scheduled during the first quarter of 2021....Hoth also plans to present clinical trial designs for the IND-opening, phase 2a dose ranging study as well as a proposed follow-up phase 2b safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy."

Clinical protocol • FDA event • Oncology

Hoth Therapeutics Announces Production of HT-001 for Cancer Treatment (PRNewswire) - "Hoth Therapeutics, Inc...announced that it has signed a production agreement for both GLP and GMP materials associated with HT-001 with Tergus Pharma for its novel cancer treatment drug, HT-001."

Licensing / partnership • Dermatology • Oncology