AlgoTx Initiates Phase II Clinical Trial for ATX01 in Rare Erythromelalgia Disease, Administers First Doses to Patients in US and Europe

Tuesday, September 12, 2023

AlgoTherapeutix, a clinical-stage biotechnology firm dedicated to pioneering therapies for peripheral neuropathic pain, has achieved a significant milestone by administering initial doses to the first patients in both the US and European segments of its Phase II proof-of-concept trial, known as EASE*. This trial, conducted under FDA and EMA Orphan Drug Designation, seeks to assess the effectiveness of the company's leading asset, ATX01, in alleviating pain associated with Erythromelalgia—a rare neurological and vascular condition currently lacking effective treatments. We anticipate receiving results from the trial in the first half of 2024.

AlgoTx employs an innovative approach that specifically targets nociceptive sodium channels involved in pain signaling. This approach involves topical administration, acting directly at the pain source with a dosage sufficient to alleviate severe pain.

Stéphane Thiroloix, Founder, President, and CEO of AlgoTx, expressed his satisfaction with the substantial progress made in their clinical trials and commended the dedicated clinical teams in the US and Germany. He underscored the company's commitment to addressing the urgent need for pain relief among Erythromelalgia patients through their targeted therapeutics.

Dr. Juergen Bauerschmitz from Universitaetsklinikum Erlangen Hautklinik emphasized the significant impact of Erythromelalgia's painful "flare-ups" on patients' quality of life. Recognizing the high unmet medical need for this rare condition, he expressed enthusiasm for leading the European segment of the Phase II clinical trial for ATX01. Universitaetsklinikum Erlangen Hautklinik is one of the leading dermatology centers in Germany.

Julio Sartori Valinotti, MD from the Mayo Clinic, is participating in the research conducted in the United States.

Furthermore, the company announced the on-schedule completion of patient recruitment for approximately half of the 240-patient Phase II trial (ACT), which includes three arms. This trial focuses on chemotherapy-induced peripheral neuropathy (CIPN), a common side effect resulting from neurotoxic cancer treatments leading to nerve degeneration.

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare Innovation & Transformation SummitHealthcare CNO SummitHealthcare CMO SummitThe Healthcare Patient Experience & Engagement Summit 2024