Lutris Pharma Completes Enrollment of Part Two of its Phase 1/2 Trial of LUT014 To Treat Radiation Dermatitis in Patients with Breast Cancer

TEL AVIV, Israel, April 6, 2022 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that it has completed enrollment of part two of its phase 1/2 clinical trial of lead compound, LUT014, a topically applied, novel B-Raf inhibitor, for the treatment of radiation-induced dermatitis (RD) in patients with breast cancer. Top-line data is expected in the third quarter of 2022.

The randomized, double-blind, placebo-controlled part two of the phase 1/2 study has enrolled a total of 20 patients and is designed to evaluate the efficacy of topically administered LUT014 in breast cancer patients with RD. Patients have been 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 strong results observed from the eight patients in Part 1 of the trial of LUT014 to treat RD, gave us additional confidence in the potential of this therapy and spurred us to begin part 2, earlier than anticipated," stated Benjamin W. Corn, M.D., Chief Medical Officer of Lutris Pharma. "There remains a significant unmet need among patients with breast cancer who suffer from RD, for whom there are currently no approved treatment options. LUT014 has a unique mechanism of actions which 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."

"Enrollment of the last patient in the blinded part two portion of our phase 1/2 study brings us one step further in the clinical development of LUT014 as a treatment for RD," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "It is estimated that approximately half of cancer patients are treated with radiation therapy, annually, and the majority of breast cancer patients, in particular, experience some form of RD. Based on the mechanism of action of LUT014, we believe that LUT104 may have a significant impact on this patient population. We look forward to reporting  robust data from this trial in the third quarter of this year."  

For more information about this clinical trial, please visit: www.clinicaltrials.gov, NCT04261387.

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 sequence of effects including an immune response cascade, leads to the symptomology associated with radiation dermatitis, which can dramatically diminish 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 – which have a weak  evidence base -- 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.

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.

Lutris Pharma
Noa Shelach, Ph.D.
Chief Executive Officer
ir@lutris-pharma.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

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