Catherine Novack: Got it. Thank you so much for taking my questions.
Todd Brady: My pleasure, Catherine.
Operator: Thank you. We will now take our last question from Yale Jen from Laidlaw & Company. Yale, please go ahead. Your line is open.
Yale Jen: Good morning, and thanks for taking the questions. In terms of INVIGORATE-2 study, that you will report the data this half, but could you give us a little bit update in terms of the — when the study started and what’s the current status of patient enrollment and others? And then, I have a follow-up. Thanks.
Todd Brady: Thanks, Yale. It wouldn’t be an Aldeyra earnings call, if I didn’t thank you for all your support over the years. It’s just been an absolute pleasure. INVIGORATE-2, I think, we started almost two years ago. And the reason I say that is because for allergen chamber trials, you cannot treat patients when there’s pollen in the air. When there’s ambient pollen, that ambient pollen compounds the activity you may or may not observe in the allergen chamber, and thus most of these allergen chamber trials are run during the winter. So, we had last year’s winter season. We have this year’s winter season. The reason why we’re guiding this half for INVIGORATE-2 is that pollen will arrive again early spring in the next month or two.
We will no longer be able to enroll patients and thus enrollment we would expect will be complete relatively soon. As a reminder, the primary endpoint, really the only FDA approved endpoint, in ocular allergy is itching, that is a patient reported itching scale, typically 0 to 4. As you know, across the Phase 3 ALLEVIATE trial, across our Phase 2 allergen chamber trial, across the INVIGORATE allergen chamber trial, the itching was significantly reduced relative to vehicle, and we’ve performed many analyses to confirm the clinical relevance of those findings. We hope to see the same thing in INVIGORATE-2. As far as we know, assuming positive data INVIGORATE-2, INVIGORATE-2 would conclude our efficacy trials for allergic conjunctivitis.
Yale Jen: Okay, great. That’s very helpful. Maybe one more here, which is for 2191 with retinitis pigmentosa data readout. What should we anticipate from that data once you report it?
Todd Brady: Well, thanks for highlighting retinitis pigmentosa. There are three major milestones for our company in this half. We just talked about INVIGORATE-2. I’ve discussed chronic cough previously. And then, retinitis pigmentosa is the third. What I think is remarkable about those three milestones is each milestone highlights a different aspect of our business. I like to think of Aldeyra in three parts, Reproxalap being one, ADX-2191 being two, and the third being the oral pipeline, and each of those aspects of our business are representative of milestones that we expect this half. Retinitis pigmentosa is particularly interesting. It is the largest of the three indications we’re currently testing with ADX-2191. To pick round numbers, one might think of roughly 400 incident patients with lymphoma, 4,000 incident patients with proliferative vitreoretinopathy and something like 40,000 incident patients with retinitis pigmentosa that relate to the particular mutations that appear to be sensitive to methotrexate administration.
The basis for using ADX-2191 and methotrexate in retinitis pigmentosa is cited in our clinical deck. It’s been a remarkable series of experiments, spanning many thousands of molecules in animal models of retinitis pigmentosa, the winner was methotrexate. And thus, investigators and many patients and certainly the staff here at Aldeyra are excited about the potential for ADX-2191 in retinitis pigmentosa. This is an open label trial. This is the first time methotrexate has been administered to retinitis pigmentosa patients. And we, as I mentioned, would expect to be able to announce results this half.
Yale Jen: Okay, great. That’s very helpful. And again, congrats for all these catalysts of this year.
Todd Brady: Exciting time, Yale. Thank you.
Operator: Thank you. I’ll now turn the call back to Dr. Brady for closing comments.
Todd Brady: Thank you for joining us this morning. We are positioned for an exciting year in 2023. And as always, we look forward to bringing our novel therapies to patients with significant unmet medical need.
Operator: Thank you everyone for joining today’s call. You may now disconnect your lines, and have a lovely day.
