At the intersection of mission-driven innovation and groundbreaking science, few leaders stand out like Dr. Stella Sarraf, founder and CEO of Amydis and Spinogenix, two Stead Impact Ventures portfolio companies.
Amydis is pioneering a new class of ocular tracers that enable digital detection and monitoring of human disease-related molecular biomarkers for brain, eye, and heart diseases, and is currently in Phase 2 trials for Alzheimer’s disease and cerebral amyloid angiopathy. Spinogenix is developing small-molecule therapeutics to restore and repair synaptic connections in the brain — offering new hope to treat people battling Alzheimer’s, ALS, schizophrenia, and other neurological and mental health conditions. It has completed Phase 2 clinical trials for ALS, Alzheimer’s disease, Fragile X syndrome, a common form of inherited autism, and is currently enrolling its Phase 2 trial in schizophrenia.
Stead Impact Ventures Board Chair Jerre Stead sat down with Stella for a conversation about her journey, her vision, and what lies ahead.
Jerre: Stella, it’s a great pleasure to have you here with me today. Most people don’t have the ability to start one company, let alone two. How did you get started?
Stella: First of all, Jerre, it’s been an honor to get to know you and be part of Stead Impact Ventures and your portfolio. Honestly, it all started as a personal mission—an unmet need.
When my father was diagnosed with Parkinson’s, his neurologist shared that if only we could have detected this earlier, there might have been hope with therapies already on the market. That planted a seed. Then, when my mother was diagnosed with breast cancer, it all started because she felt a lump, went to her OB-GYN, and we were able to tackle the disease early. That early detection gave her a chance.
With my background in venture capital and my expertise in chemistry and drug development, I saw a huge gap in our healthcare system. I thought, why not leverage what we already know about the eye as part of the solution. People have changes in their eyesight and go to an eyecare provider allowing for early access to a doctor who can refer to a neurologist. The retina is neuronal tissue and part of the central nervous system. It’s accessible and routinely imaged at micron level resolution during routine eye exams. Why couldn’t we use that tissue to visualize neurodegenerative diseases?
That idea became Amydis. We began developing small molecules, what I now call retinal or ocular tracers, to label molecular biomarkers that are disease specific, making the invisible visible.
Jerre: And then, a few years later, you started Spinogenix.
Stella: Yes. Amydis taught me a lot, not just scientifically, but also about the challenges of building something new in an uncharted space. But as we were advancing the diagnostics, I realized that we need more and better therapeutic options as well.
So, in 2016, I launched Spinogenix. Our approach is different from most others in the neurodegenerative space. We focus on what I call “ground zero” — the synaptic connections in the brain.
We’re developing small molecules, not antibodies or complex biologics, because small molecules can be formulated into drug tablets enabling good patient compliance. Today, both Amydis and Spinogenix are in Phase 2 human clinical trials, advancing multiple programs for multiple diseases.
Jerre: When I look at what you’re building, Stella, it feels like a once-in-a-lifetime opportunity to change the world. You’re working on areas that Mary Joy and I feel so passionate about and have supported throughout the years in both the neurodegenerative disorder and mental health spaces, where patients desperately need better options. Can you share more about Spinogenix’s impact on diseases such as ALS, Alzheimer’s disease, schizophrenia, and mental health?
For Alzheimer’s disease, the hope is to restore memory and give patients back their lives, allowing them to realize meaningful improvements in independence and enjoy activities they lost the ability to do. For a fatal disease like ALS, the hope is to make it a chronic condition.
Stella: Absolutely. With Spinogenix, we’re working at the synaptic level targeting the fundamental connections that drive how our brains function. When you’re young, you have a huge number of synapses, that’s why children learn so quickly. Over time, growth slows and as we age disease processes can start damaging those connections.
In conditions like Alzheimer’s, ALS, schizophrenia, bipolar disorder, depression, and PTSD, synaptic dysfunction is at the core of the disease process. By repairing synaptic connections, we’re unlocking the potential to help patients regain function — not just slow decline.
For Alzheimer’s disease, the hope is to restore memory and give patients back their lives, allowing them to realize meaningful improvements in independence and enjoy activities they lost the ability to do. For a fatal disease like ALS, the hope is to make it a chronic condition. Instead of slowing or halting the progression of the disease, the goal is to reverse declines in cognitive and motor functions. And because our therapeutic is a small molecule pill, it offers the potential for broad, efficient distribution to patients globally as well as the potential for combination therapy in the future.
We have a second drug that works at the synaptic level to correct specific dysfunctions in Fragile X syndrome (FXS), a common form of inherited autism. For people with FXS, the hope is to improve overall quality of life by reducing core symptoms such as severe anxiety, social aversion, hyperactivity and attention deficit, and sensory abnormalities, while gaining the ability to manage daily activities and improve interactions with others.
Jerre: It’s so exciting how you are doing exactly what we have hoped for, bending the curve downward on these devastating conditions. Drug development is a marathon, looking back, what’s been the toughest part of the journey?
Stella: There have been a lot of dark days. The hardest part has been bridging the gap from animals to humans.
Advancing to clinical trials with strong preclinical data in hand is expensive, and sometimes investors don’t fully see the value in completing the required regulatory studies that is critical. We had to be creative. We secured non-dilutive funding from organizations like the NIH, the Department of Defense, and the Michael J. Fox Foundation. That support is pivotal. Amydis was recently awarded a follow-on NIH grant for $2.5M to further its work in detecting TDP43, the protein linked to ALS and other neurodegenerative disorders, which could mark a watershed moment in ALS screening and diagnostics.
And, Jerre, meeting you and having your mentorship has been game-changing. Having someone who believes in the mission and pushes me forward has made all the difference and brightens my days.
Jerre: One of the things that impresses me most is your unwavering focus on patients. Where does that come from?
Stella: It’s personal. I’ve been the caretaker, the daughter holding my parents’ hands through their battles. I know what that sense of urgency feels like.
Every participant in our clinical trials is my hero. Every email from someone asking to join a trial keeps me forging ahead. Even when doors close, we just keep pushing until we find people who can help us meet our vision.
And my team feels the same way. Many of us have been personally affected by these diseases. This isn’t just work for us, it’s a mission. We love what we do because we know we’re making a difference every day.
Jerre: I also want to say congratulations on being named by Forbes as one of its “50 Over 50” list of the most innovative women entrepreneurs, inventors, and wealth-builders!
Stella: Thank you, I’m proud to stand with so many trailblazing women pushing science and innovation forward.
Jerre: Looking ahead, where do you see Amydis and Spinogenix in the next two years?
Stella: By 2027, I see us helping a lot of people. I wish we could move faster, but drug development takes time and resources. What keeps me going is knowing that every step we take gets us closer to changing lives. Every day is exciting, and I’m incredibly proud of how far we’ve come, and how much more is ahead.
Jerre: Every time we talk, I think about this and am excited about the difference your work will make for so many people around the world.