This study data was reinforced by Aldeyra Therapeutics Inc. Therapeutic pathway for a new drug application, likely in Q3/22, a HC Wainwright & Co.
Aldeyra Therapeutics Inc.’s (ALDX: NASDAQ) Reproxalab has been shown, by results of recent clinical trials, to be effective in treating dry eye disease, according to HC Wainwright & Co., analyst Matthew Coffield. In a research note dated July 13. These data bode well for the New Drug Application (NDA) that the biotech intends to submit to the US Food and Drug Administration (FDA) for reproxalab, likely in the third quarter of the year 22.
Reproxalap is a RASP, or reactive aldehyde species, 0.25% ophthalmic solution to be administered topically.
“Reproxalap has shown a strong and consistent benefit for dry eye disease,” Coffield added. “We view RASP inhibition as representing a viable new pathway in addressing the current therapeutic limitations of dry eye disease.”
Coffield noted that approved dry eye disease treatments on the market can take months to have a noticeable effect, have inconsistent responses among patients, can be uncomfortable, and often cause patients to stop using them.
Caufield highlighted that the newly released positive data, from the vehicle-controlled crossover trial of reproxalap, show that the drug met both primary and secondary endpoints of statistical significance.
With riproxalab, study participants showed improvement in:
1) Dry eye redness in the eye chamber, primary end point, (p = 0.0004). Benefit is observed initially at 10 minutes and then within the last 90 minutes after entering the room.
2) Schirmer’s test to assess tear production 1 day after dosing, primary end point, (p = 0.0005). This result supports the previous dosing activity and the activity of the fourth dose versus the one-day dosing.
3) Schirmer’s test greater than or equal to 10 mM responder analysis, secondary endpoint, (p = 0.0361).
Other secondary endpoints of reproxalap showed benefit in dry eyes (p = 0.0068), discomfort (p < 0.0001), severity (p = 0.0001), tongue (p = 0.0001), burning (p < 0.0001) and itching (p = 0.0003). ).
Coffield wrote that these “reflect a broad representation of potential symptom benefit within a characteristically heterogeneous set of indicators”.
Reproxalap has also shown a positive safety and tolerability profile. The most common adverse drug-related event was mild and transient discomfort at the site of administration.
“This more recent data set provides direct support for RASP inhibition of previous TRANQUILITY-2 and TRANQUILITY experiments,” Coffield commented.
In the next step for its reproxalap program, Aldeyra will meet with the FDA for feedback before introducing an NDA, the most likely near-term trigger for the drug’s developer, according to Caufield.
The analyst also noted that the FDA does not require that all potential dry eye disease drug benefits be shown in a single clinical trial. Instead, each benefit must be proven in more than one clinical trial. This is the case with reproxalap, which simplifies the path of approval for it.
HC Wainwright has a buy rating and a stock price target of $15 on Aldeyra, with a current share price of approximately $5.06.
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HCWainwright & Co. Disclosures , Aldeyra Therapeutics, July 13, 2022
HC Wainwright & Co, LLC (the “Company”) is a member of FINRA, SIPC, and a US registered broker-dealer.
I, Matthew Caufield and Andrew S. Phin, certify that 1) all opinions expressed in this report accurately reflect my personal opinions about any and all securities or issuers being discussed; and 2) no part of my salary was or would be directly or indirectly related to the specific recommendation or opinions expressed in this research report; 3) Neither I nor any of my family members is an official, director, or member of the advisory board of these companies. None of the Research Analysts or the Research Analyst family has a financial interest in Aldeyra Therapeutics’ securities (including, without limitation, any option, right, security, future, long or short position).
As of June 30, 2022, neither the Company nor its affiliates beneficially owns 1% or more of any class of Aldeyra Therapeutics’ common stock. Neither the research analyst nor the company knew or had reason to know of any other material conflict of interest at the time this research report was published.
The research analyst primarily responsible for preparing the report does not receive compensation based on any specific investment banking services or transactions, but is compensated based on factors including total revenue and the company’s profitability, a large part of which is derived from investment banking services. The Company or its subsidiaries have received compensation from Aldeyra Therapeutics for their non-investment banking services in the past 12 months.
The company or its subsidiaries did not receive compensation from Aldeyra Therapeutics for investment banking in the twelve months prior to that, but will seek compensation from the companies mentioned in this report for investment banking within three months after the research report is published.
The company is not doing market business in Aldeyra Therapeutics as of the date of this research report.
The securities of the company discussed in this report may not be suitable for investors depending on their specific investment objectives and financial situation. Past performance is not a guarantee of future results. This report is provided for informational purposes only, and does not constitute an offer or a solicitation to buy or sell any securities discussed herein in any jurisdiction where this is prohibited. This research report is not intended to provide tax advice or be used to provide tax advice to anyone. Electronic versions of HC Wainwright & Co., LLC’s research reports are made available to all customers simultaneously.
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