Introduction
Apart from the abundant preclinical data showing efficacy in animals, XPro has been tested in six patients in the Phase 1 trial. Randomized, blinded, placebo-controlled phase 2 trials in MCI and AD are about to start, should be ended by beginning of 2023 and mid 2023 respectively, and the company has stated they would be going for accelerated approval which is backed by recent Biogen developments for AD and FDA guidance for MCI.
As a reminder, in all of these patients, an entire set of biomarkers for inflammation decreased massively, 15% over twelve weeks (CSF) and 45% over the course of twelve months (MRI). There was a 100% response to therapy. All biomarkers of neurodegeneration and synaptic function improved drastically.
The most striking measure in that respect is NFL, neurofilament light, a biomarker for neurodegeneration that is seen increased in all neurodegenerative diseases, including long Covid-19 patients. On XPro, NFL dropped by 84% over the course of three months, which is unseen by far (see here).
The testimonials
What this looks like in people at only three months has been discussed in a webinar on XPro of 15 July 2020 by Dr. Rosalyn Lai, who saw two patients in one of the trial centers, which has since been viewed 1,115 times, and that’s telling about how undiscovered INmune Bio is.
“I'd like to turn the microphone over to Dr Rosalyn Lai to put this all in a clinical perspective.
She's the one who is actually taking care of patients, sees their response, and I'd like her to relay that to you before I actually dive into the data and we get into the what and why of neuroinflammation, XPro and Alzheimer's disease. Rosalind?
Thank you, RJ, thank you for the warm welcome.
As RJ has mentioned, I'm a geriatric psychiatrist by background and I'm a consultant psychiatrist over at the St. George hospital in Sydney. I’m also the principal investigator at the Cara institute of neurological diseases in Sydney. As a researcher in dementia, it has been really exciting to be
involved in the XPro trial. I've been so heartened, and I'll admit, I've been pleasantly surprised to hear some of the profound changes that some of our participants have been reporting. As you will appreciate, for people with Alzheimer's disease and their loved ones, they don't really care about the score of their mini mental or the progression of their cognitive scales. For them it's their day-to-day functioning and their capacity to engage in meaningful activity and experiences that give them pleasure and joy that's important. So I'm going to give you a couple of the stories of change from our participants that are going through this trial, and hopefully you'll be able to appreciate how remarkable this improvement has been for them.
So, the first gentleman I present, let's call him Andrew. So, this gentleman was a larger than life character, he was really social gregarious, he was part of the executive board of a football club and a big movie buff. He's been suffering early onset Alzheimer's dementia for a number of years, and when he came to us, he was really a shell of his former self. He was very apathetic and socially withdrawn with very limited language use. In fact, his families would say that he would spend most of his day sleeping in his recliner. He'd need help with prompting for majority of his self-care tasks since being on this trial. He's had a gradual and steady improvement. His wife tells us that he's back to his old self and he's regained his personality. He's brighter and more alert, he's interested, focused, and he's engaging in day-to-day life. When he came to us, he hadn't watched television for 18 months, and he's started returning to watching the movies that he used to love, and he's also started to watch his football again, and he's been engaging in conversations with his children and his grandchildren about how the footy's been going and who's going to make the next round. Socially, he's now able to hold a conversation, and more importantly his sense of humor has returned, and his wife tells us he's cracking one-liners like he used to. From a functional perspective, he's now able to brush his teeth, dress and shave independently, which is remarkable. His wife even expressed surprise to us the other day that he pulled out his old aftershave, and he hadn't used this for years.
When they reached the end of their 12-week trial, this family were willing to do absolutely everything to stay on this drug. They were willing to go to the TGA, which is your version of the FDA, they're willing to lobby politicians, go to the media, because it was just such a a huge change they observed in him, and they're really grateful that he's now in the extension phase currently.
So Andrew's looking forward to one major goal in the future. One of his children is getting married in February, and he's really looking forward to being part of their big day, and the family are looking forward to seeing him there with his real essence returned. So, that's been a lovely story to hear.
The other gentleman I'd like to present, let's call him Bob, he's a retired deputy principal of a high school, and he's got a background in pharmacy and science, and he's a teacher of physics. He came to us on the milder end of the Alzheimer's spectrum, having stopped work five years ago, when he noticed that he was starting to forget the formula that he needed to teach his students. Since being on his trial, he's telling us: ‘Now, I've gone back to my usual life.’ He feels energized, motivated, and his concentration and memory have improved. He's now able to recall physics formulae, and far more, and he's even taken on a few students to tutor during this covert time.
He's gone back to reading academic journals, and he finds that he's not only able to understand the information that he's reading but, and as for all of you who read academic journals, you'll recognize this is no easy feat, he's also able to recall that information later.
He's even started writing a book which he'd been considering for a number of years beforehand, but hadn't had the motivational courage to start.
So, as you can see, for both of these participants, there's been a meaningful functional improvement that's occurred in quite a short period of time.
So that's been super exciting to be a part of.”