Curemark Presents Preschool Population Data from Phase 3 Blüm Autism Study

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May 06, 2019, 13:13 ET

RYE, N.Y., May 6, 2019 /PRNewswire/ -- Curemark, LLC announced today that results from its Phase 3 clinical trial, the Blüm Study, were presented at the International Society of Autism Research (INSAR) Annual Meeting held in Montreal, Canada from May 1-4, 2019. The presentation focused on data from the preschool population included in the Blüm Study.

INSAR, formed in 2001, is a scientific and professional organization devoted to advancing knowledge about autism spectrum disorders (ASD). The INSAR Annual Meeting is the Society's scientific meeting convened each spring to exchange and disseminate scientific progress from ASD scientists and researchers around the world.

The presentation, titled "Pancreatic Replacement Therapy with CM-AT is Associated with Reduction in Maladaptive Behaviors in Preschoolers with Autism," was presented by Dr. Deborah Pearson, Professor of Child and Adolescent Psychiatry at the University of Texas, Houston, and demonstrates statistically significant improvements in core and non-core symptoms of autism in the preschool subpopulation taking CM-AT versus placebo.

"We are honored to have presented our findings to the autism research community," commented Dr. Joan Fallon, Curemark's Chief Executive Officer. "Our data suggests that CM-AT has an effect on core and non-core symptoms, including communication, in children ages 3 through to 6 with autism. These are promising findings given the limited treatment options for this youngest patient population."

About Curemark, LLC

Curemark, LLC is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of neurological disorders. Curemark's pipeline includes preclinical and clinical-stage programs for the treatment of autism, ADHD, addiction, schizophrenia and Parkinson's disease. For additional information, please visit our website at http://www.curemark.com or follow @Curemark on Twitter.

About the Blüm Study

The Blüm Study, completed in 2018, was a 14-week, double-blind, randomized, placebo-controlled Phase 3 study conducted to determine if CM-AT may help improve core and non-core symptoms of autism. CM-AT, which has been granted Fast Track designation by FDA, is designed to enhance protein digestion, thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine.

Safe Harbor

This press release includes both historical facts and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include statements regarding the development of Curemark, LLC's lead drug candidate, CM-AT, for autism and its potential to serve medical needs. In some cases, forward-looking statements can be identified by words such as "may," "will," "should," "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," "predict," "potential," the negative of such words, variations of such words and similar expressions, although not all forward-looking statements contain these identifying words.

These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among other things: (i) uncertainties inherent in research and development; (ii) the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates; (iii) the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; (iv) whether and when any marketing applications may be filed with any jurisdiction for CM-AT; (v) whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; (vi) decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CM-AT; and (vii) competitive developments.

Readers should not place undue reliance on any forward-looking statements, which are based on Curemark, LLC's current expectations of future events and speak only as of the date they are made. Except as may be required by law, Curemark, LLC undertakes no obligation to update any forward-looking statements contained in this press release to reflect any change in Curemark, LLC's expectations or any change in information, events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

SOURCE Curemark, LLC