DAVIS, Calif.--(BUSINESS WIRE)--Arcadia Biosciences, Inc. (NASDAQ: RKDA), an agricultural technology company, announced today that the US Food and Drug Administration (FDA) has completed the Early Food Safety Evaluation (EFSE) process for the plant protein responsible for the company’s Nitrogen Use Efficiency (NUE) trait. Completion of this review is a critical milestone in the development of Arcadia’s pipeline of 13 nitrogen use efficient crops, four of which are in the latter phases of product development.
The FDA EFSE review supported the conclusion that the functional protein for the NUE trait, alanine aminotransferase, is safe for consumption by humans and animals and would not raise safety concerns if present in the food supply. The EFSE is applicable to all plant species utilizing Arcadia’s NUE trait.
“Seed products based on the NUE trait are in development for most major global crops,” said Eric Rey, president and CEO of Arcadia Biosciences. “Completion of the EFSE process provides our seed company partners with assurance of gene safety. The core safety data used in the EFSE process will facilitate regulatory approvals for all crops that ultimately will bring this yield-enhancing trait to farmers worldwide.”
Conventional crops use only about half of applied nitrogen fertilizer. Much of the remainder moves through the soil and enters ground and surface water systems, or volatilizes into the air as a greenhouse gas 300 times more potent than carbon dioxide. Arcadia’s NUE trait was developed to help farmers increase yields while reducing costly fertilizer usage and improving the environmental footprint of agriculture.
Arcadia and its commercial partners are testing crops with the NUE trait at 16 field trials worldwide in 2015. The trait’s efficacy has been demonstrated in major crops including rice, wheat, barley, sugarcane and canola. To date, three years of independent field trials of NUE in rice have demonstrated an average yield increase of 27 percent in multiple environments. Field trials of NUE wheat lines over multiple locations and crop seasons demonstrated an average yield increase of 10 percent for the leading lines across a range of nitrogen application rates.
“Coupled with the recent regulatory approval of drought tolerant soybeans in Argentina for our joint venture Verdeca, completion of the EFSE process validates Arcadia’s significant capabilities to manage the regulatory framework for new crop traits,” Rey said.
The data provided by Arcadia to the FDA in support of the EFSE for the NUE trait is consistent with international regulatory requirements for genetically modified crops and will be utilized by Arcadia and its global partners for future regulatory submissions. Arcadia is currently pursuing an additional EFSE for the HB4 drought tolerance trait being utilized in multiple crops in conjunction with Bioceres SA.
About Arcadia Biosciences, Inc.
Based in Davis, Calif., with additional facilities in Seattle, Wash. and Phoenix, Ariz., Arcadia Biosciences (NASDAQ: RKDA) develops agricultural products that create added value for farmers while benefitting the environment and enhancing human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salinity Tolerance, Heat Tolerance and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition traits and products are aimed at creating healthier ingredients and whole foods with lower production costs. The company was recently listed in the Global Cleantech 100 and was previously named one of MIT Technology Review's 50 Smartest Companies. For more information, visit www.arcadiabio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's NUE trait and the regulatory process for such trait. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company and its partners’ ability to develop commercial products incorporating its traits, including the NUE trait, and complete the regulatory review process for such products; the company’s compliance with laws and regulations that impact the company’s business, and changes to such laws and regulations; the company’s future capital requirements and ability to satisfy its capital needs; and the other risks set forth in the company's filings with the Securities and Exchange Commission from time to time, including the risks set forth in the company's Registration Statement on Form S-1 (including the final prospectus dated May 14, 2015) and other filings. These forward-looking statements speak only as of the date hereof, and Arcadia Biosciences, Inc. disclaims any obligation to update these forward-looking statements.