Aldeyra Therapeutics Announces Positive Results From Phase II Clinical Trial in Subjects With Noninfectious Anterior Uveitis
Topical corticosteroids are often associated with ocular toxicity, including cataract formation and glaucoma (elevated intra-ocular pressure). The data released today suggest that NS2 has the potential to reduce or replace corticosteroid use in noninfectious anterior uveitis.
Commenting on the results,
Forty-five subjects were randomized equally to receive NS2 0.5% four times daily, Pred Forte® 1% (a corticosteroid) four times daily (tapered), or NS2 0.5% four times daily and Pred Forte® 1% twice daily (tapered). There were no statistical differences among all groups in any clinical endpoint, including anterior chamber cell count and ocular flare. NS2 was generally well tolerated and there were no serious adverse events, consistent with previous Phase I and Phase II clinical trials.
NS2 produced clinically meaningful effects on anterior chamber cell counts (ACC) comparable to corticosteroid. At the week 2 study visit, grade 0 (cell count of zero or one) ACC treatment response was seen in 33% of NS2 patients, 31% of Pred Forte® patients, and 31% of patients on combination therapy. At the week 8 study visit, grade 0 ACC treatment response was seen in 40% of NS2 patients, 46% of Pred Forte® patients, and 44% of patients on combination therapy. For ACC improvement of at least one grade, treatment response was seen in 53% of NS2 patients, 46% of Pred Forte® patients, and 50% of patients on combination therapy. For subjects that did not respond to therapy, rescue medication rates were similar between NS2 and Pred Forte®, with rescue medication required in 20% of NS2 patients, 38% of Pred Forte® patients and 25% of patients on combination therapy.
The principal investigator of the trial, Dr.
Aldehydes are thought to mediate both major forms of inflammation, allergy (such as allergic conjunctivitis) and autoimmune disease (such as noninfectious anterior uveitis). In
Additional Recent Highlights
- Reported positive results from Phase II clinical trial in subjects with allergic conjunctivitis. Aldeyra reported that the results of a randomized, parallel-group, single-center, double-masked, vehicle-controlled Phase II clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant and sustained activity of NS2 over vehicle in reducing ocular itching and tearing. NS2 was generally well tolerated and there were no serious adverse events during the trial.
- Phase II clinical data in Sjögren-Larsson Syndrome expected in third quarter of 2016. Aldeyra confirmed that the results of a Phase II clinical trial of dermatologic NS2 for the treatment of ichthyosis in Sjögren-Larsson Syndrome, an inborn error of aldehyde metabolism, are expected in the third quarter of 2016.
- Hired key employees for pipeline advancement. In
January 2016, Aldeyra hired David J. Clark, M.D. as Chief Medical Officer. Dr. Clarkhas 18 years of drug development experience at Pfizer, SmithKline Beecham, and several biotechnology companies focused on rare and common diseases. Aldeyra also hired Mary Taylor, MPH as the Senior Vice President, Regulatory Affairs in February 2016. Ms. Taylor'sindustry experience spans over 30 years in drug development and senior regulatory positions at Shire, Bayer, and multiple biotechnology companies. The additions of Dr. Clarkand Ms. Taylorenhance the ability to advance multiple treatments through the clinic and to the market for a number of inflammatory diseases and inborn errors of aldehyde metabolism.
First Quarter 2016 Financial Review
For the quarter ended
Research and development expenses were approximately
General and administrative expenses were approximately
Cash, cash equivalents and marketable securities were
Conference Call and Webcast Information
The Company will hold a conference call on
After the live webcast, the event will remain archived on the
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis is a rare, potentially blinding disease that may be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that is thought to be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling and redness.
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome is a rare disease caused by mutations in fatty acid aldehyde dehydrogenase, leading to elevated fatty aldehyde levels that are thought to contribute to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. There is no
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 statements regarding Aldeyra's plans for its product candidates and its financial guidance. 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
In addition to the risks described above and in Aldeyra's other filings with the
|Cash and cash equivalents||$||10,148,524||$||14,648,866|
|Prepaid expenses and other current assets||283,509||497,552|
|Total current assets||23,309,314||28,088,194|
|Deferred offering costs||45,986||36,236|
|Fixed assets, net||81,466||80,334|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current portion of credit facility||193,866||77,546|
|Total current liabilities||1,807,771||2,115,135|
|Credit facility, net of current portion and debt discount||1,101,968||1,211,310|
|Commitments and contingencies|
|Common stock, voting,
|shares issued and outstanding, respectively||9,713||9,713|
|Additional paid-in capital||84,084,750||83,478,851|
|Accumulated other comprehensive income (loss), net of tax||1,800||(8,361||)|
|Total stockholders' equity||20,527,027||24,878,319|
|Total liabilities and stockholders' equity||$||23,436,766||$||28,204,764|
|STATEMENT OF OPERATIONS|
|Three Months Ended
|Research and development||$||3,511,477||$||1,136,434|
|General and administrative||1,455,559||972,101|
|Loss from operations||(4,967,036||)||(2,108,535||)|
|Other income (expense):|
|Total other income (expense), net||(316||)||(28,024||)|
|Net loss per share:|
|Weighted average common shares outstanding:|
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