Company Receives FDA Guidance thru Pre-IND response

LOS ANGELES, April 13, 2021 (GLOBE NEWSWIRE) -- PREXA SANTÉ today announced positive top-line results from a human clinical trial of Product-118, the company’s proprietary combination medical device/drug treatment for COVID-19. Preliminary data from the clinical trial indicated Product-118, after just a few days of once daily doses, was highly effective as a treatment for COVID-19, with no reported side effects.

Based on the study results, PREXA SANTÉ on January 13, 2021, submitted a Pre-IND meeting request to the U.S. Food and Drug Administration (FDA), the company received a written response-providing the understanding on the requirements for opening an Investigational New Drug Application for the filing of a New Drug Application (NDA) and eventual Product approval. PREXA SANTÉ has incorporated the FDA guidance into its Product-118 program and planning for manufacturing and filing of the New Drug Application,for a multi-national clinical study of Product-118 for the treatment of COVID-19, which is planned to commence within the next several months..

“We are extremely pleased with the preliminary 49 subject data, which showed that Product-118 Eradicated the COVID-19 virus in patients after receiving just three-daily doses,” said Christine Collins, MD, Chief Medical Officer of PREXA SANTÉ. “We look forward to working towards FDA approval, and advancing our multi country clinical planned dosing of Product-118”.

“Our multi-country medical and research team, including Prexa Santé Staff, physicans at Institute for Social Security and Services for State Workers (ISSSTE) Research at Aldofo Lopez Mateo Hospital and Center for Scientific Research and Higher Education at Ensenada (CICESE), have worked tirelessly to establish, monitor, audit and complete the clinical trial. ISSSTE has begun hospital treatment. We hope this product will benefit the many patients around the world suffering from COVID-19.”

PREXA SANTÉ is working with Anessa Pharma LLC to commercialize Product-118. The companies are in the process of registering, and seeking approval of Product-118 with COFEPRIS, the equivalent of the FDA in Mexico.

“We are pleased to collaborate with PREXA SANTÉ to make this potentially important drug available to patients in the U.S.,” said Ray DiFalco, President for Anessa Pharma LLC. “This Product represents our continued commitment to partner on drug development and commercialization efforts to provide patients with ground breaking products for both branded and prescription pharmaceuticals.”

Product-118, a combination medical device/drug treatment, is being studied as a treatment for COVID-19.

About Prexa Santé: Prexa Santé, a U.S.-based company, is focused on the science behind and administration of preventative and regenerative medicine. Product-118 is the company’s first preventative medicinal product. Other medicines in development are focused on addressing pressing public health / diagnostic issues, along with athletic performance enhancement treatments. For more information visit www.prexasante.com.

About Anessa Pharma: Anessa Pharma LLC, a privately held company, is engaged in the research, development and manufacturing of pharmaceutical Products. The company’s expertise in both solid and liquid dosage products, extends across a range of drug delivery technologies. For more information visit www.AnessaPharma.com.

CONTACT:
Robert Jaffe
rjaffe@rjaffeco.com
424-288-4098