LEXINGTON, MA--(Marketwired - Feb 22, 2017) - Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today announced that it has developed and launched the Aldeyra Registry for Sjögren-Larsson Syndrome (SLS), a rare inborn error of aldehyde metabolism that is characterized by severe skin and neurological disease. The Aldeyra Registry for SLS is designed to unite SLS patients worldwide, and to raise awareness of the significant physical challenges associated with the disease.
"We are delighted to collaborate with the SLS patient community on the critical task of uniting patients affected by this rare but serious disease with no FDA-approved therapy," commented Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "By facilitating the degradation of the toxic fatty aldehydes that accumulate in patients with SLS, our lead compound, ADX-102, has the potential to improve the debilitating symptoms of the disease. The Aldeyra Registry is multilingual and open to SLS patients and their caregivers and doctors."
SLS is caused by genetic mutations in Fatty Aldehyde Dehydrogenase (FALDH), an enzyme that metabolizes long-chain aldehydes. The primary day-to-day complaint of SLS patients and their caregivers is ichthyosis: severely dry, itchy skin. Patients with this debilitating disease are consistently disturbed by their dermal symptoms, which affect most of the body surface, and often excoriate their skin by scratching. There is currently no FDA-approved treatment for these symptoms. A late-stage randomized, double-blind, vehicle-controlled clinical trial of ADX-102, applied topically to the skin of SLS patients, demonstrated improvements in the severity of ichthyosis. A Phase 3 trial is expected to begin enrollment in the second half of 2017.
"The Aldeyra Registry is an important effort that can ultimately help all SLS patients. I commend Aldeyra for taking a leadership role and partnering with the SLS and rare disease patient communities," said Dr. William Rizzo, Vice-Chair in Pediatrics at University of Nebraska Medical Center, a leading expert in SLS.
Patients, caregivers, and physicians that register will receive information about Aldeyra's therapeutic development program in SLS, as well as opportunities to participate in clinical trials. Visit the Aldeyra Registry for SLS at: www.aldeyraregistry.com
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra's lead product candidate, ADX-102, is an aldehyde trap in development for ocular inflammation, as well as for Sjögren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism. Aldeyra's product candidates have not been approved for sale in the U.S. or elsewhere.
Sjögren-Larsson Syndrome (SLS)
Sjögren-Larsson Syndrome is a rare inborn error of aldehyde metabolism caused by mutations in fatty acid aldehyde dehydrogenase, leading to elevated toxic fatty aldehyde levels that are thought to contribute to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. There is no therapy for SLS that has been approved by the U.S. Food and Drug Administration.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding Aldeyra's plans for its product candidates, expected development timelines and potential benefits of the Aldeyra Registry for SLS. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra's product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the size and growth of the potential markets for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency of Aldeyra's cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2015, and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are on file with the SEC and available on the SEC's website at www.sec.gov. Additional factors may be set forth in Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017.
In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.