TEL AVIV, Israel, Oct. 5, 2021 /PRNewswire/ — Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that, based on the compelling results observed in part one, it has initiated part two of its phase 1/2 trial of lead compound, LUT014, a topically applied, novel B-Raf inhibitor, for the treatment of radiation-induced dermatitis (RD) in breast cancer patients.
Part two of the phase 1/2 study is expected to enroll a total of 20 patients (10 per part) and is designed to evaluate the efficacy of topically administered LUT014 in breast cancer patients with RD. Patients in the part two, double-blind, placebo-controlled portion will be randomized in a 1:1 ratio to receive either topically administered LUT014 or placebo for 28 days, followed by a 2-month follow-up period.
The primary endpoint of part two is the change in severity of radiation dermatitis based on a self-reporting Dermatology Life Quality Index (QoL) questionnaire at 14 days. Secondary endpoints include change in the severity of radiation dermatitis based on the Dermatology QoL questionnaire and the incidence of treatment-emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading scale from baseline to 12 weeks.
“The fact that we have been able to begin the blinded part two portion of our phase 1/2 study of LUT014 to treat RD earlier than we had originally anticipated, is a direct reflection of the strong results observed in part one and gives us additional confidence in the potential of this important therapy,” stated Ben Corn, M.D., Chief Medical Officer of Lutris Pharma. “There remains a significant unmet need among patients with breast cancer who suffer from RD. It is estimated that approximately 50% of cancer patients are treated with radiation therapy, annually. Of these, most patients experience some form of RD. LUT014 aims to balance the destruction of cells in the basal layer of the skin by enhancing cell proliferation, thus potentially reversing the effects of RD. We, therefore, believe that LUT104 may have a significant impact on this patient population, for whom there are currently no approved treatment options.”
For more information about this clinical trial, please visit: www.clinicaltrials.gov, NCT04261387.
About Radiation Dermatitis
Radiation therapy results in ionization events that lead to damage of cellular macromolecules, including double-stranded DNA breaks. Within the epidermis, this DNA damage disrupts the normal proliferation and differentiation of basal keratinocytes, depleting the differentiated epidermal keratinocytes and ultimately resulting in the loss of the protective barrier provided by the skin. This, combined with DNA damage disruption within the dermis, which results in a complex set of effects including an immune response cascade, leads to the symptomology associated with radiation dermatitis, which can dramatically affect a patient’s quality of life. Severe radiation-induced dermatitis can lead to a limitation of radiotherapy or interrupt the treatment schedule which might compromise outcome.
There is currently no FDA-approved drug whose labelled indication is for the prevention or treatment of radiation-induced dermatitis. Rather, patients are merely treated with supportive cutaneous care. These treatments have included topical steroids, non-steroidal anti-inflammatory topicals, and hyaluronic acid derivatives. To date, none has been definitively proved efficacious.
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. The B-Raf protein is part of the EGFR pathway and has shown to be mutated in some human cancers such as melanoma cancer. Blocking the B-Raf pathway in B-Raf mutated cancer cells leads to tumor shrinkage, but when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAP Kinase pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses this paradoxical effect in order to reverse the effect of EGFR inhibitors on downstream proteins in the skin cells, thereby reducing dose-limiting acneiform lesions associated with EGFR inhibitor treatment.
About Lutris Pharma
Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma’s lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients. For more information, please visit www.lutris-pharma.com.
Noa Shelach, Ph.D.
Chief Executive Officer
Rx Communications Group
SOURCE Lutris Pharma