Amylyx Pharmaceuticals Investor update
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Everyone, welcome and thank you so much for joining us today, both here in the room as well as on the webcast. I'm Camille Bedrosian, Chief Medical Officer at Amylyx. We are so excited to be here at ObesityWeek, as well as having the opportunity to share with all of you the aspects of post-bariatric hypoglycemia, as well as the potential of avexitide, an investigational first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation. Throughout today's program, you'll hear from leading PBH experts as they discuss the burden of PBH, the unmet need, as well as the phase III LUCIDITY results in more detail. Before we begin, as you know, we will be making some forward-looking statements during the presentation, so please refer to the slide that you're seeing here, as well as to the information that's on our investor website. Here is the agenda for today.
First, we'll begin with a short video. Very important to hear from a member of the PBH community who shares with us her experience living with the condition. It will raise quite a bit of awareness about what people live through with this condition. Next, we'll hear from Dr. Zaid Said from Brigham and Women's Hospital, who will provide an overview of PBH, including patient burden, clinical challenges, and ongoing unmet medical need. Then we'll hear from Dr. Marilyn Tan, who will review the LUCIDITY results presented earlier today at ObesityWeek, and share her perspective on the clinical significance of these results. Following these presentations, Jamie, our SVP of Medical Affairs, will moderate a discussion and Q&A session with our experts. That includes both their comments as well as questions from all of you here in the room, as well as on the webcast.
Before we begin, I do want to share a few key themes for today's discussion to level set everyone. First, PBH is a debilitating condition with no approved treatments, and that has a profound impact on patients' quality of life. Secondly, in LUCIDITY, avexitide demonstrated consistent, highly statistically significant, and clinically meaningful reductions in hypoglycemic events across all endpoints, and you'll hear that further from Dr. Tan. Third, based on the strength and consistency of the data, we do believe that avexitide has the opportunity to potentially change the practice in PBH. Before we begin and dive further into the science and the clinical data, we'd like to share a patient perspective. And patient's experience actually taught us a great deal about PBH as we were understanding more about avexitide as well, and it is the center of everything we do and what we will be discussing today.
The following video shares the experience of one member of the PBH community.
Let's take a look. My name is Maria, and I was diagnosed with post-bariatric hypoglycemia in 2021.
I had Roux-en-Y bariatric surgery back in 2019. I've always really struggled with my weight. As I got older, I started developing some health issues. My life before surgery was not really life. I couldn't walk 20 feet without having to sit down. My physician told me that my best option for survival was bariatric surgery. I knew that I was limited on time if I didn't do anything, and I wanted to be here for my family. The bariatric surgery exceeded my expectations. I went from existing to living. I lost 120 pounds in the first seven months after the surgery. I was no longer on any medications whatsoever for my blood pressure or anything else. I was out and about doing things that I had not done in decades. Life after surgery was amazing.
After my mom had bariatric surgery, it seemed like she was finally getting to live her life, where she never really had that opportunity before.
The very early signs and symptoms of PBH that I had starting in 2020 were just feeling really tired after I ate, and I started experiencing some issues with standing and suddenly feeling like if I didn't go lay down, I was going to fall down on the floor.
My mom and I were in the kitchen together, and she starts shaking. She goes down to the ground. I started typing in bariatric surgery, all of her symptoms that she's feeling. Finally found this article, and it was like this aha moment, like, "Okay, we found it." Post-bariatric hypoglycemia is what we found.
I called my primary care physician, and she referred me to an endocrinologist. When my endocrinologist told me that there were no approved treatments for post-bariatric hypoglycemia, it was a huge blow. It was devastating. Regardless of what it is that I eat, it will send my blood glucose into a spike. As soon as it hits its peak, it suddenly makes a turnabout and drops like a rock. Whatever I correct with, usually some form of food or juice, my body reacts to it, and I spike again, and I drop again. Sometimes you've lost an entire day of just battling this.
I have watched my mom go from this hopeful spark, going on adventures, having a wonderful time, embracing this new life, to a very deep depression.
The uncertainty of when my glucose is going to plummet is debilitating. I can't make plans because I don't know if I'm going to be able to complete that task safely. This isn't the life I was dreaming of. It's just, I'm existing again. My endocrinologist put me on a medication for chronic weight management. It doesn't help with all of the symptoms of post-bariatric hypoglycemia for me. Unfortunately, I do still have the brain fog. I do still have the spikes and the drops. The need to lay down after I eat is all still there, so it's still debilitating for me. Being able to have a little bit more confidence in the fact that I could enjoy my life again would be overwhelming. I do not regret having that surgery. I am sitting here today because of that surgery.
My hope is that one day there will be a cure for post-bariatric hypoglycemia. If we can't get a cure, at least an adequate treatment that will address the symptoms of PBH.
Thank you for listening. Now it's my great pleasure to introduce Dr. Zeb Saeed, who will discuss PBH in more detail.
Thank you, Zeb. Thank you, Dr. Bedrosian, and good afternoon, everyone.
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