Mary, statistical alpha is split between the Bayley-4 cognitive raw score at 80% and the multi-domain responder index, or MDRI, at 20%. This is not a hierarchical evaluation, meaning both endpoints are tested in parallel. If the Bayley Cognition endpoint reaches a p-value equal or less than 0.04, or if the MDRI reaches a p-value equal or less than 0.01, we will have a statistically successful phase three study. We designed and powered the study to hit both endpoints, but we do not need both endpoints to achieve statistical significance in order to have a successful study. Across the Phase I-II program, patients have now been on continuous therapy for an average of three years with the longest approaching five years, which represents the most significant and mature data set in the field. These patients continue to demonstrate meaningful improvements across multiple development domains while maintaining a consistent safety profile. The Phase I to open-label single-arm data demonstrates substantial clinical benefit, well beyond what might be considered with placebo, though it is in an open-label setting. We believe that the long-term experience beyond the first year of treatment remains even more important as we evaluate the potential for GTX102 to provide meaningful benefit with chronic dosing in the commercial setting. Shifting to UX143 or citruzumab, our monoclonal antibody for the treatment of osteogenesis and perfected. At the end of last year, we shared the results from the phase three orbit and cosmic studies. While neither study hit statistical significance for the primary endpoints of annualized fracture reductions, we did see clear signals of biologic activity, statistically meaningful improvements in bone mineral density and patient reported outcomes and meaningful reductions in fractures in certain bones and in patients with higher fracture frequencies. Since then, we have continued analyzing the data and have had discussions with regulators in the U.S. and U.K. Based on the discussion with the MHRA, we believe that a new randomized study may be needed before they would consider reviewing an application for approval. The FDA indicated openness to considering alternative approaches to fracture analysis, and we will need additional conversations with them to further define what additional clinical data would be needed to support a potential BLA. I'll now turn the call back to Emil to provide a reminder of our catalyst for 2026 and some closing remarks.
Thank you, Eric. I'll close with a few of the important catalysts we have later this year. A full list can be seen in the corporate deck posted to our website. Starting with DTX401 for the treatment of Glycerous Doral Disease type 1A, where we continue to work with FDA ahead of our PDUFA action date of August 23rd. Next, UX111 for the treatment of Sanfilippo syndrome, similar to DTX401, we continue to work with FDA ahead of Pidufa action date of September 19th. And lastly, GTS1-2 for the treatment of Ainsman syndrome, where we're on track to read out top-line Phase III data from the ASPIRE study in the September or October timeframe. The second quarter reinforced the continued strength of our global commercial business and our expertise in developing first-ever medicines for patients with rare diseases. We are ready for potential launches, continue to execute across the portfolio, and are approaching a set of milestones that could meaningfully expand our impact for patients and accelerate the next phase of growth for ultrigenics. With that, let's move on to your questions. Operator, please provide the Q&A instructions. Thank you.
Operator
And at this time, we'll be conducting a question and answer session. Please limit yourselves to one question and one follow-up question for each time you enter the queue. To ask a question, press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star queue. And our first question comes from Kristen Kluska with Cantor Fitzgerald. Please state your question.
Hi, good afternoon. Congrats on a really strong quarter. For Angelman syndrome, I was hoping you could provide a little bit more context on these endpoints, specifically if the FDA has signed off, whether one endpoint or not would be sufficient for filing, and then also understanding what's clinically meaningful, understand that these both endpoints were powered for success, but were they also powered to show results that the community would deem clinically acceptable?
We had our discussion with the FDA on the sharing of primary alpha, and that was agreed to in our end of phase two and false discussions on the two endpoints. So sharing of alpha means that either endpoint can be positive in their analysis. With regard to powering, we are powering based on the effects we've seen, but we think a five or six point change, for example, in the Bayley should be sufficient to achieve significance, and that would be the six point level is considered clinically meaningful. For the MDRI, it only scores if there's clinical meaningful results, that is, each domain improvement requires a threshold of clinical meaningfulness. And in that, previously we've seen, as we remember in phase two, about two domains net positive that were in the clinical meaningful range. So because of the design, we would see MDRI would be positive only with clinically meaningful results. So at this point, we'll be comfortable about the two endpoint approach, and we think the Empowering will be positive with collectible results based on our plan. We will see the data when they come.
Thanks, Operator. Let's move to the next question.
Operator
Thank you. Your next question comes from Yaron Werber with TD Cowan. Please say your question.
Great. Thanks so much. So maybe on the MDRI endpoint, which I think has generated some confusion from investors, as you notice, it's the first and most important secondary, but it's really a co-primary. And it's not been used before in Angelman, but you've used it in some of your other MPS disorders. Can you talk about the level of sensitivity and whether it's a better endpoint than cognition, just given that it's a global primary? Thank you so much.
Yes, the MDRI approach simply captures efficacy across multiple domains using a clinical...