Lutris Pharma Receives Notice of Allowance for Key U.S. Patent Application Covering Lead Compound, LUT014, a Novel B-Raf Inhibitor

Notice of Allowance of Patent Application for Use of Topical B-Raf Inhibitors for the Treatment, Prevention or Alleviation of Radiation Dermatitis, Strengthens Intellectual Property Position Until 2041

TEL AVIV, Israel, July 11, 2022 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application No. 17/384,221, filed on July 23, 2021, entitled, "Use of Topical BRAF Inhibitor Compositions for Treatment of Radiation Dermatitis." When issued, Lutris will have a total of 20 issued national patents covering 15 countries, as well as 19 patents pending.

The allowed claims cover Lutris' novel compounds, including lead compound, LUT014 and also commercial B-Raf inhibitors, for the topical treatment, prevention or alleviation of radiation dermatitis. The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The patent resulting from this application will have an expiration date of no earlier than February 11, 2041. Based on the U.S. patent allowance, Lutris plans to obtain fast-track allowance for patent applications in other countries.

"The receipt of this Notice of Allowance from the USPTO for topically applied LUT014, is another important milestone that further strengthens our broad intellectual property portfolio for our novel B-Raf inhibitors," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "Radiation dermatitis is a condition that can dramatically affect quality of life.  To address this, LUT014 is designed to balance the destruction of cells in the basal layer of the skin resulting from radiation, by enhancing cell proliferation, thus potentially reversing the effects of radiation dermatitis. We, therefore, believe that LUT104 may have a significantly positive impact on this patient population, for whom there are currently no approved or effective treatment options. Backed by the strong results observed in part 1 of our ongoing phase 1/2 study of LUT014 in radiation dermatitis, we look forward to reporting data from the blinded part two of the trial in the coming months."

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma cancer, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

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 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.

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. 

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 and enable patients' adherence to anti-cancer treatment.

Lutris Pharma is currently assessing the effectiveness of LUT014 in two clinical studies: a randomized, double-blind, placebo-controlled efficacy and safety study of topically administered LUT014 in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions (NCT04759664), and a Phase 1/2 open-label followed by blinded study evaluating the safety, tolerability and efficacy of topically administered LUT014 (LUT-RD) in breast cancer patients with radiation induced dermatitis (RD) (NCT04261387).

For more information, please visit www.lutris-pharma.com.

Contacts:

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

Logo - https://mma.prnewswire.com/media/1586358/Lutris_Logo.jpg