Now, let me walk you through some of the key highlights and recent updates. First, turning to HOPE-3, our ongoing Phase III pivotal study, which was initiated in the second quarter, which included site selection and activation of certified Duchenne centers. HOPE-3 is a randomized double-blind placebo-controlled study with the goal to enroll 70 patients at approximately 15 to 20 investigative sites in the United States.
In July, we reported the initiation of enrollments and I am very pleased to inform you that as of today, we have enrolled seven patients. We have a growing list of interested candidates and we are optimistic that we will now gain momentum in the recruitment of the trial.
HOPE-2, our Phase II study, which was published in The Lancet last year, together with the recent late breaking open label extension data presented at this year's Parent Project for Muscular Dystrophy, or PPMD Annual Conference in June, are amplifying the interest in our HOPE-3 trial. Our current projections for enrollments are to be complete by the third quarter of 2023 or sooner.
The promise of HOPE-3 builds on the recently reported HOPE-2 open label extension data, which continue to underscore the therapeutic potential of CAP-1002 and highlight it's sustained safety and efficacy.
Let me recap that data for you to highlight its relevance to our regulatory strategy and the clinical development of CAP-1002. HOPE-2 open label extension was a very unique clinical study, which allows each patient to be used as their own control.
First, we conducted Hope-2 where one group received placebo and one group received CAP-1002. Those results showed statistical and clinically significant improvement in upper limb function in non-ambulant patients with DMD, as earlier mentioned and published.
Then, all patients went off treatment into what we call a gap phase, which was approximately one year. All patients no matter what group they were originally in declined in upper limb function during the gap days.
Then all patients went on CAP-1002 in the open label extension part of the trial and disease progression was attenuated up to 70%, most notable and those that were originally on placebo.
What is also interesting is that the original CAP-1002 group declined off therapy at the same rate that the placebo group did, but entered the open label portion of the trial with better upper limb function due to the fact that they had the benefit of one year of CAP-1002 in HOPE-2.
They started with better upper limb function and therefore, finished with better upper limb function. This is exemplary of potential disease modifying behavior of a therapeutic.
We believe this data must be shown to FDA, both because of its statistical power and clinical benefit, but also because time is muscle, based on this dataset, every year that patients are off CAP-1002, they lose function that cannot be recovered, based on our regulatory designations of RMAT, or Regenerative Medicine Advanced Therapy and orphan disease designation, and also the importance of this data to people with DMD.
We are requesting a meeting with FDA, which should occur this year to present this open label extension data, which we believe will further support our path forward towards potential regulatory approval.
However, we remain focused on executing on our HOPE-3 clinical trial, which is slated to be our pivotal trial. To remind you HOPE-3's primary endpoint is the performance of the Upper Limb 2.0 a validated tool to assess skeletal muscle function in non-ambulant patients, and also the measure in which we saw statistically significant results and HOPE-2 and in HOPE-2 open label extension. This meeting will complement a CMC meeting, which is required prior to BLA submission, which we are planning to hold later this year as well.
Another key priority for our CAP-1002 program involves preparing for the future potential commercial launch, including the scale up of manufacturing. While our current manufacturing site in Los Angeles is fully focused on supplying our HOPE-3 clinical trial, we are supplementing our manufacturing efforts by converting a portion of our San Diego labs to support potential early commercial launch.
We see this facility as a versatile and cost-effective measure. Additionally, our manufacturing plan encompasses the work we have done at Lonza as they may be an important part of our future scaled up commercial plan for CAP-1002.
As you know, we entered into a distribution and commercial agreement with Nippon Shinyaku and its U.S. subsidiary NS Pharma, an experienced and well-resourced commercial partner in the United States. NS Pharma has been a trusted DMD partner for the community and has already established a respected infrastructure to support patients and their caregivers.
If approved, we believe Nippon Shinyaku's leadership in this space will serve CAP-1002 well, enriching more eligible patients who could benefit from our therapy. As a reminder, Capricor's agreement with Nippon Shinyaku came with a $30 million upfront payment to Capricor and has a potential to reach up to $705 million in milestone payments, some of which, if achieved, will be paid during the course of HOPE-3.
To maximize the potential benefit of CAP-1002 and reach patients globally, we will continue to explore ex-U.S. partnership opportunities. Our goal is to continue to execute on our regulatory, clinical, CMC, and business development goals as I just outlined above, as we are committed to bring in CAP-1002 to patients as quickly as possible.
