#USA #Miami #Hoth Therapeutics #HT-001 #CLEER-001

Hoth Therapeutics Accelerates Trial Enrollment

Hoth Therapeutics, a clinical-stage biopharmaceutical company, has recently announced a strategic expansion of its CLEER-001 Phase 2a clinical trial. This decision comes in response to a surge in patient demand for its treatment, HT-001, aimed at alleviating skin toxicities associated with EGFR inhibitor chemotherapy. With the addition of Regis Clinical Research in Miami, Florida, the CLEER-001 investigational site network is set to grow, allowing for quicker enrollment of participants.

The Need for Innovative Therapies

Each year, approximately 200,000 Americans undergo EGFR inhibitor therapy, which, although life-saving, often leads to debilitating skin conditions such as rashes and lesions. Up to one-third of these patients may be forced to reduce or discontinue their treatment due to the severity of these side effects, which currently do not have an FDA-approved remedy. HT-001 has been developed to address this pressing issue, and initial clinical results are promising.

Encouraging Early Data

The interim data from the CLEER-001 trial paints a hopeful picture:

• - An impressive 100% of participants in the open-label cohort achieved a significant reduction in rash severity within six weeks.
• - No patients required dose reductions or therapy discontinuation while receiving HT-001.
• - Over 65% of participants experienced considerable relief from pain and itching.
• - Importantly, no dose-limiting toxicities were recorded throughout the entirety of the trial to date.

These results not only underline the efficacy of HT-001 but also suggest a shift in how oncologists may manage skin-related side effects, which significantly impact patients' quality of life. A case study presented at the American Academy of Dermatology Annual Meeting showcased remarkable patient outcomes, with one individual experiencing complete symptom resolution after just one week of therapy.

A New Enrollment Site

The incorporation of Regis Clinical Research into the CLEER-001 trial network not only enhances the geographical reach of the study but also helps meet the growing interest from patients and physicians alike. Regis brings FDA-compliant research capabilities and access to a diverse patient population in South Florida, thereby enabling Hoth Therapeutics to speed up enrollment and effectively fulfill its regulatory and clinical objectives.

"The addition of Regis Clinical Research is a direct response to the acceleration we are witnessing in enrollment demand, and the data certainly speaks for itself," stated Robb Knie, CEO of Hoth Therapeutics. This move is essential for paving the way toward obtaining crucial regulatory milestones.

Next Steps for Participants

Interested patients and physicians can find more information about participating in the CLEER-001 trial by visiting regisclinical.com or calling +1 (305) 546-3952. This opportunity could significantly influence the approach to cancer-related skin side effects and lead to better treatment options for countless patients.

About Hoth Therapeutics

Hoth Therapeutics is focused on developing innovative therapies that aim to improve the quality of life for patients. The company specializes in both early-stage pharmaceutical research and clinical development, prioritizing a collaborative approach with experts in the field to ensure the discovery of impactful and groundbreaking treatments. For additional details, please visit Hoth Therapeutics.

Forward-looking statement: This press release contains forward-looking statements based on Hoth’s current projections and expectations, which are subject to change due to various risks and uncertainties inherent in clinical research and regulatory processes.