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Have seen the unexpected strong placebo effect too. In a U.K. cat allergy trial the reduction in allergic reaction was 60% and exactly 60% too for the placebo arm in phase 3 study. In the phase 2 studies the drug had proven superior statistical significance.
I do agree that the ALDX choice of 0.1% solution is worrisome, particularly as I have seen no dose response data or explanation of this assumed minimum response dose.
As you said, nor is it clear what ALDX have agreed with the FDA. Is it confirmation of statistical significance against placebo for the 0.5% dose, while simply accepting whatever minimal dose effect we get. Or is there some set expectation from the 0.1% arm.
I don't know, but CEO Brady seems to think it is all Dandy. I guess only time will tell.
"vehicle/placebo showed a greater than expected effect" is a phrase everyone fears in clinical testing and can often be a dealkiller. Trials designed to test against an inert placebo may seem like easy slam dunks (vs. active SOC) until the trial design is violated in practice and the fail is uncovered only after unblinding at the fag end. Happened to ITEK when some patients in just 2 trial sites figured they got the placebo and helped themselves to alt. treatment undisclosed while on the trial. If something similar happened with the ALDX p2a trial, thankfully their 0.5% dose was strong enough to hit the ball out of the park in every instance to render the trial a success regardless of placebo 'outperformance.' If there is similar placebo activity in p2b, I'm pretty sure the 0.1% arm will not beat it. I'm not sure how the market will read this outcome and not optimistic of a favorable interpretation. I wish the comparator arm was the current SOC to avoid trial abuse. I've quadrupled down here and will take half off the table before readout. Not expecting a rapid/robust bounce-back as ALDX has relatively few deep-pocketed/fluid sponsors but it will climb over May & June into announcement. In this unreal market, investors are the tail wagging the market dog and the trail the price traces is more their imprint than an efficient reflection of co. fundamentals.
Having looked again at Clinicaltrials.gov and thought about it, [ceiling] possible should have been 'healing'.
It seems vehicle, that is the placebo, had greater than expected effect, while 0.5% dose still showed superior statistical significance. I don't know how Aldeyra have arrived at 0.1% as the control arm for establishing minimum effective dose (as required by the FDA), but we must assume they have previously determined some form of dose response curve to make them confident that 0.1% is high enough to show effect against even a strong placebo effect.
Then Tom Brady is adding that, all that being correct, establishing minimum effective dose is all they are missing to potentially have the FDA agree the P2b trial and results leading directly to a P3 registration trial.
Understand your concern on how Aldeyra chose 0.1% and why they feel confident about that being a minimum effective dose. Hopefully IR will eventually provide a reply to you (let us know), but I guess we just have to decide if we trust Tom Brady and crew on the science.
I might double or quadruple down. If successful the rest of the pipeline, not least ADX-102 in SLS with Orphan Drug Designation, is awesome.
I think [ceiling] is a best guess filled in word by the conference call service due to the audio being intelligible to them.
Your interpretation is probably right.
I considering adding too. The ALDX pipeline, and possibly beyond, is attractive assuming the whole aldehyde trapping approach ultimately turns out to be right.
Investor2014, Thx for your response. Still can't get my arms around what constitutes a successful outcome in this 3-arm trial. I have no doubt the 0.5% arm will succeed to demonstrate statistical significance as before. I have doubts the 0.1% arm will do the same in a statistically meaningful way. I would think the headline would then deem the p2b trial a failure.
The 3 arms are: Drug: ADX-102 Ophthalmic Drops (0.5%) Drug: ADX-102 Ophthalmic Drops (0.1%) Drug: Vehicle of ADX-102 Ophthalmic Drops
Mgmt. says...
I don't understand the last line, including: "use [ceiling] as control" - is that the 0.5% dose as control? "...such that there is no doubt that there is any interaction between the vehicle and the allergens used to stimulate the response" - totally missing how this would be proved by inclusion on 0.1%. Outcome of 0.1% should have no bearing on proof that the inactive vehicle has no effect on the allergic conjunctivitis condition. ie. it is immaterial if 0.1% arm statistically succeeds or fails as long as the inert vehicle arm does not outperform it.
I have written IR & Tulipano a note but doubt I'll receive a response.
FYI, I too had a small position but upped it to meaningful size on this downswing on expectation of readout in June/early-July.
I have held a small'ish position in ALDX for about a year and keep an eye.
My (educated layman's) view on the science is positive. With regards to your question, I think the quote below from the latest investor's call sounds objectively confident.
The 0.1% arm is meant as a control against the statistically SUPERIOR 0.5% dose. Since the response was higher than anticipated with 0.5%, and presumably with a dose response curve being available, I think it is reasonable to expect to see a statistically significant response also at 0.1%.
Investor2014, not sure if you follow ALDX closely but with the ongoing allergic conjunctivitis p2b trial do you know why the FDA told mgmt to add the 0.1% arm? makes me very nervous dreading the scenario 0.5% statistically succeeds as before while 0.1% fails. If mgmt isn;t interested in testing/selling 0.1% why is FDA forcing it to?
Pretty cut & dry clinical testing schedule with allergic conjunctivitis p2b results next on tap shortly.
Seems to me the dip is due to one of the current insty's lightening up. Small float with thin trading causes insty moves to stand out like a sore thumb for the mkt. makers.
Thinking, it will regain high 4's once it clears but fail to break 5 until runup top2b results.
The Company is developing a treatment for diseases thought to be related to high levels of free aldehydes, naturally occurring pro-inflammatory toxins.
Aldeyra Therapeutics, Inc. (the Company) was incorporated in the state of Delaware on August 13, 2004 as Neuron Systems, Inc. On December 20, 2012, the Company changed its name to Aldexa Therapeutics, Inc. and on March 17, 2014, the Company changed its name to Aldeyra Therapeutics, Inc. The Company is developing a treatment for diseases thought to be related to high levels of free aldehydes, naturally occurring pro-inflammatory toxins.
The Company’s principal activities to date include raising capital and research and development activities.
The Company’s initial public offering of common stock (Initial Public Offering) was completed on May 7, 2014.
As of August 6, 2014, there were 5,565,415 shares of the registrant’s common stock issued and outstanding.