Curemark Completes Enrollment for its Phase 3 Clinical Trial for Children with Autism - The Blüm Study

RYE, N.Y., Sept. 25, 2017 /PRNewswire/ -- Curemark, LLC announced today that the Blüm Study, its second Phase 3 clinical trial to evaluate the safety and efficacy of CM-AT in children aged 3-8 with autism, is fully enrolled.

"On behalf of the Curemark team, I would like to thank the Blüm Study families, our Investigators, and their teams for partnering with us on this important autism study," said Dr. Joan Fallon, founder and CEO of Curemark. "We are also grateful to the many autism-focused organizations across the country, large and small, that have supported the Blüm Study.   Autism is a significant unmet medical need and the completion of this Phase 3 study of CM-AT is an important step forward in the advancement of autism research. We look forward to completing the study and submitting our New Drug Application in 2018."

The 14-week, double-blind, randomized, placebo-controlled Phase 3 study was 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.

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.

Safe Harbor

This press release, as well as information about the Blüm Study located at www.blumstudy.com, includes forward-looking statements.  These forward-looking statements include statements regarding (i) the development of Curemark, LLC's lead drug candidate, CM-AT, for autism, (ii) CM-AT's potential to serve medical needs, (iii) the anticipated completion of the Blüm Study to evaluate CM-AT, (iv) the anticipated submission of a New Drug Application for CM-AT and (v) CM-AT's mechanism of action.  In some cases, forward-look 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 New Drug 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 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