Lutris Pharma Receives FDA Orphan Drug Designation for LUT014 for the Treatment of EGFRI-Induced Acneiform Rash

Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to lead compound, LUT014, a novel topically applied B-Raf inhibitor, for the treatment of EGFR (Epidermal Growth Factor Receptor) inhibitor induced acneiform rash. Currently, no drug or treatment is approved by the FDA for the prevention or treatment of EGFR inhibitor induced acneiform lesions.

“Receipt of orphan drug designation for LUT014 is strategically important for Lutris, as it reflects the significant unmet need for patients treated with EGFR inhibitors, approximately 75% of whom develop some grade of acneiform rash, and allows for an expedited FDA regulatory pathway for LUT014,” stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. “The ODD also qualifies us for incentives including tax credits for qualified clinical trials, exemption from user fees and potentially seven years of marketing exclusivity for LUT014, should it gain approval for the treatment of EGFRI inhibitor acneiform rash. The ODD designation is, therefore, a meaningful milestone for this program, as our mission from the start has been to improve anti-cancer therapy effectiveness, as well as the quality of life for patients who are being treated with EGFR inhibitors. It will be integral to our ability to potentially bring this important treatment to patients faster.”

“As a result of the dermal toxicity caused by EGFR inhibitors, many of these patients do not receive the optimal treatment against their cancer, either due to dose reduction or even discontinuation, caused by the rash,” added Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma. “Importantly, results from our phase 1 trial of LUT014 in patients with metastatic colorectal cancer who had developed grade 2 rash demonstrated the safety of the approach as well as provided preliminary favorable efficacy results and a dose response. We look forward to reporting results from the ongoing phase 2 randomized clinical trial of LUT014 in treating skin toxicities caused by EGFR inhibitors in the future.”