Aldeyra Therapeutics Inc.'s (ALDX:NASDAQ) reproxalap was shown, via recent clinical trial results, to be effective for dry eye disease, reported H.C. Wainwright & Co. analyst Matthew Caufield in a July 13 research note. These data bode well for the new drug application (NDA) the biotech intends to submit to the U.S. Food and Drug Administration (FDA) for reproxalap, likely in Q3/22.
Reproxalap is a RASP, or reactive aldehyde species, inhibiting 0.25% ophthalmic solution to be administered topically.
"Reproxalap demonstrated robust and consistent dry eye disease benefit," added Caufield. "We view RASP inhibition as presenting a viable novel pathway in addressing current dry eye disease therapeutic limitations."
The approved dry eye disease treatments on the market, noted Caufield, can take months to have an appreciable effect, have inconsistent responses among patients, and can be uncomfortable, often causing patients to stop using them.
Caufield highlighted that the newly released positive data, from the vehicle-controlled crossover reproxalap trial, show the drug met primary and secondary endpoints with statistical significance.
With reproxalap, study participants exhibited improvement in:
1) Dry eye chamber ocular redness, primary endpoint, (p=0.0004). The benefit was observed initially at 10 minutes and then through the final 90 minutes after chamber entry.
2) Schirmer test tear production assessment after one day of dosing, primary endpoint, (p=0.0005). This result supports prior dosing activity and fourth dose activity versus single-day dosing.
3) Schirmer test greater than or equal to 10-millimeter responder analysis, secondary endpoint, (p=0.0361).
Other secondary endpoints reproxalap showed a benefit in were ocular dryness (p=0.0068), discomfort (p<0.0001), grittiness (p=0.0001), stinging (p=0.0001), burning (p<0.0001) and itching (p=0.0003).
These "reflect a broad representation of prospective symptom benefit within a characteristically heterogeneous indication population," wrote Caufield.
Reproxalap also demonstrated a positive safety and tolerability profile. The most common drug-related adverse event was mild, fleeting discomfort at the administration site.
"This most recent data set provides direct RASP inhibition support for the prior TRANQUILITY-2 and TRANQUILITY trials," Caufield commented.
In the next step for its reproxalap program, Aldeyra will meet with the FDA for feedback before submitting the NDA, the most imminent near-term catalyst for the drug developer, according to Caufield.
The analyst also pointed out the FDA does not require all benefits of a prospective dry eye disease drug to be exhibited in one clinical trial. Rather, each benefit must be demonstrated in more than one clinical trial. This is the case with reproxalap, simplifying the approval path for it.
H.C. Wainwright has a Buy rating and a $15 per share price target on Aldeyra, the current share price of which is around $5.06.
|Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter.||Subscribe|
1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. They or members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
Disclosures for H.C.Wainwright & Co., Aldeyra Therapeutics, July 13, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Matthew Caufield and Andrew S. Fein , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Aldeyra Therapeutics (including, without limitation, any option, right, warrant, future, long or short position).
As of June 30, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Aldeyra Therapeutics. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Aldeyra Therapeutics for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from Aldeyra Therapeutics for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in Aldeyra Therapeutics as of the date of this research report.
The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.
H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.
The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.
Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.