Initiates Clinical Proof of Concept Study for NFX-179 Gel for the Mitigation of Cutaneous Neurofibromatosis Type-1
Funding round led by venBio Partners and F-Prime Capital
NFlection Therapeutics, Inc., a biopharma therapeutics developer dedicated to targeting disease pathways to uncover new approaches to fighting rare disease, today announced the closing of a $20 million Series A financing round with investment from venBio Partners and F-Prime Capital. The company also announced the initiation of the first clinical trial of its lead product, NFX-179 Gel, a topically applied therapy.
The Phase 2a study, on the heels of the successful submission of their Investigational New Drug Application with the U.S. Food and Drug Administration, will be a safety, tolerability and pharmacokinetic/pharmacodynamic study of NFX-179 Gel in adult patients with cutaneous neurofibromatosis type-1 (NF-1). This study will evaluate three concentrations of NFX-179 Gel compared with its vehicle (placebo) in a randomized, double-blind, placebo-controlled, clinical trial of 48 patients with cutaneous neurofibromatosis type-1. The study will be conducted at five investigational centers across the United States.
“This study allows us to determine the drug’s ability to suppress key biomarkers involved in the progression of neurofibromas and will aid in the selection of doses for a larger Phase 2b study,” said Christopher Powala, president & chief executive officer of NFlection. “There are no FDA-approved products for this condition, and NFX-179 Gel has the potential to address this unmet medical need.”
“Almost all adults with neurofibromatosis type-1 develop cutaneous nerve tumors during their lifetime. The tumors form under the skin and manifest as nodules that can be stigmatizing and even painful,” said Annette Bakker, Ph.D., President, Children’s Tumor Foundation. “We are pleased that NFlection has recognized the unmet need posed by cutaneous neurofibromas, and we are encouraged that topical NFX-179 may hopefully soon provide a life-changing solution for thousands of NF-1 patients.”
Click here to read the rest of the press release from NFlection Therapeutics.
Click here for information on the NFX-179 Gel clinical trial.
