Disarm Therapeutics Announces First Subject Enrolled in EPIPHANY Natural History Study of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

EPIPHANY study aims to characterize CIPN disease progression and associated biomarkers to guide future therapeutic development of SARM1 inhibitors

Cambridge, Mass., Sept. 4, 2019 – Disarm Therapeutics, a biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central driver of neurological disease, today announced the first subject enrolled in the ChemothErapy-Induced PerIPHeral NeuropAthy Natural HistorStudy (EPIPHANY). This prospective observational study will characterize CIPN disease course and associated biomarkers in breast cancer patients receiving paclitaxel or docetaxel, or lymphoma patients receiving vincristine.  The EPIPHANY study will enable Disarm’s efforts to develop therapeutics that target SARM1, a protein that has been identified as the central driver of axonal degeneration in diseases such as CIPN.

“At Disarm, we are developing a new treatment approach for diseases of the central, ocular, and peripheral nervous systems by preventing axonal degeneration through SARM1 inhibition,” said Dr. Alvin Shih, President and CEO of Disarm Therapeutics. “The initiation of EPIPHANY is an important step toward gathering critical data on the progression of CIPN, informing our clinical development plans, and ultimately paving the way for Disarm to address this and other serious neurological diseases.”

“CIPN affects many patients undergoing chemotherapy, and it can persist long after treatment has ended,” said Dr. Charles Loprinzi, Professor of Oncology at the Mayo Clinic and co-chair of the study’s steering committee. “CIPN is a serious problem that may impact the ability to complete an adequate course of chemotherapy. Preventing CIPN in people receiving chemotherapy could have a dramatic impact on both cancer outcomes and quality of life.”

“No disease-modifying treatments exist for CIPN,” said Dr. Gordon Smith, Professor and Chairman of the Department of Neurology at Virginia Commonwealth University and co-chair of the study’s steering committee. “EPIPHANY is the first step in developing therapeutics not only for those suffering from CIPN but also for others with neurological diseases caused by axonal degeneration, such as MS and ALS.”

The EPIPHANY study is being conducted at 10 sites in the U.S. and will enroll approximately 200 subjects. Information collected from participants includes demographic data, medical history, patient-reported outcomes, clinician-reported outcome assessments, and neurofilament-light chain (NF-L) levels. NF-L is a biomarker for axonal degeneration that may be used to assess disease progression and measure efficacy of therapeutics.

To be eligible for this observational study, potential participants must be older than 18 years of age, diagnosed with breast cancer or lymphoma receiving taxanes or vincristine regimens, show no evidence of metastases in the central nervous system or clinically significant evidence of pre-existing peripheral neuropathy, and not have previously been exposed to neurotoxic chemotherapy drugs. Enrollment in the study must be completed prior to receiving the first dose of chemotherapy.  For additional information about the trial, please visit https://www.clinicaltrials.gov/ct2/show/NCT03997981.

About Chemotherapy-Induced Peripheral Neuropathy (CIPN)

CIPN is a degeneration of nerve fibers resulting from chemotherapy. Symptoms of CIPN include pain, motor weakness, loss of sensory perception at the extremities, and autonomous nervous system impairment. There are currently no approved disease-modifying treatments for CIPN.

About Disarm Therapeutics

Disarm Therapeutics is a biotechnology company that is creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central driver of neurological disease-causing disability and disease progression. By inhibiting the SARM1 protein, identified by the company’s scientific founders as the central driver of axonal degeneration, these therapeutics may prevent the loss of axons in chronic and acute diseases of the central, ocular, and peripheral nervous systems. For a broad range of diseases including multiple sclerosis, amyotrophic lateral sclerosis, glaucoma, and peripheral neuropathies, the therapeutic goal is to prevent further degeneration, stabilize disease, and allow for functional recovery. Disarm was founded by Atlas Venture, Dr. Jeffrey Milbrandt and Dr. Aaron DiAntonio of Washington University in St. Louis, and a team of exceptional scientists and drug developers committed to developing a new treatment paradigm for patients with neurological diseases. For more information, please visit www.disarmtx.com.

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Sara Green, Ten Bridge Communications