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Aldeyra's Reproxalap Progress And Other News: The Good, Bad And Ugly Of Biopharma


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Aldeyra Therapeutics Goes Ahead with Reproxalap for Dry Eye Disease

Aldeyra Therapeutics Inc. (NASDAQ:ALDX) reported that it has struck a deal with the FDA for the use of Reactive Aldehyde Species or RASP for the treating dry eye disease. The agreement has been reached on the basis of meetings, discussions and preliminary written comments. The company stated that it plans to provide further updates on its development plans and submitting NDA obligations for reproxalap in dry eye disease in July 2020.

Aldeyra is currently working on reproxalap, which is its first in class RASP inhibitor. In a Phase 2a study, the drug candidate showed reduction in tear RASP level after 28 days of treatment. During in vitro studies, the drug candidate was able to eliminate RASP in 60 to 90 minutes of administering equimolar concentrations. Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra said, “Representing the first novel objective sign for the treatment in dry eye disease in over a decade, RASP are critical mediators of inflammation. We look forward to continuing to advance reproxalap, our novel RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, toward NDA filing.”

RASP are pre-cytokine pro-inflammatory mediators which are found to be in the higher amount in the tears of patients suffering from dry eye disease. These also correlate with dry eye disease signs and symptoms. The drug candidate is applied topically to the eye and is believed to have more than 500-fold than tear RASP levels. Reproxalap has also shown consistent clinically relevant and statistically significant activity in dry eye disease, allergic conjunctivitis, and several other types of ocular inflammation in various Phase 2 and Phase 3 clinical trials.

Reproxalap is currently undergoing Phase 3 INVIGORATE trial and the results are expected to

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Comments (10)

Clairvoyant Investor profile picture
@ Avisol Capital Partners, what do you think of PTGX? They are an overlooked biotech that is already a triple bagger for me this year so I was just curious what you thought about them?
You are going to have a very long wait in ALDX. It;s hype. The FDA demands at least 1,500 patients dosed in at last two late stage clinical trials. ALDX has done about 700-800 so far. Read carefully what CEO says: "We look forward to continuing to advance reproxalap, our novel RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, toward NDA filing.”. Now, it can take perhaps 5-6 months ti design the last 800 patient trial and get FDA okay. The CRO that ALDX uses is ORA Inc of Andover MA. Right now, Ora has FIVE dry eye trials ongoing and ALL of them are significantly delayed. ALDX is at the back of the line. I woudl not expect they could start the last trial till maybe Q1 2021...and if 700-800 pts, it will take 10-12 months to excute and report data. Now you are in to early 2022. THEN, the FDA normal review is 10 months after you file NDA, unless it get's priority 6 month review. It is now June 2020 and my guess the earliest you se if it is approved is late 2022 or early 2023. a lot can happen in meantime. DO NOT FORGET! therer are FIVE other dry eye drugs in progress that ALL will report their data long before ALDX finishses it;s final trial. I'd avoid this name.
@snogreen I appreciate your estimate on the timeline for approval of the drug by the FDA. I think these dates are hard to foresee but I have found they always seem to take longer than one hopes. Early 2023 seems reasonable for the very large transformative milestone for ALDX.
Reproxalap uses Captisol which is an excipient made by Ligand Pharmaceuticals and used also in remdesivir which is the Covid treatment produced by Gilead. Ligand recently announced in a letter that it is scaling up production of Captisol fro a capacity of 60 metric tons per annum to 500 metric tons per annum. Drug development takes time but reproxolap looks like it will have a role in dry eye disease and allergic conjunctivitis to me.
SpikerLexus profile picture
Could get fast tracked don`t forget! JMO & no position yet as there are a lot of players in the field.
It is not going to get fast trackd. That is fp crrtitcial unment needs.. There are right now drugs for dry eye...Restasis, Xiidra and a stroid sold by BAusch and Lomb.
Clairvoyant Investor profile picture
Thanks for the update on Aldeyra. 7 bagger minimum and that will be the start as the pipeline is further developed
@Dont Tread on Me I own it too. I bought it because I have two friends who suffer from this condition and am excited about the progress....this is on my "Never Sell' list. :)
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