AOBiome Therapeutics – Transforming Human Health via Novel Microbiome-Based Therapies for Inflammatory Conditions

“The microbiome is on a more accelerated path, and with our clinical results in eczema, itch, acne, and rosacea, we are among the first to demonstrate its true promise.”

AOBiome Therapeutics (AOBiome) is a leading clinical-stage biotherapeutic company focusing on the research and development of a novel class of drugs for inflammatory conditions, central nervous system disorders, and other systemic diseases. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple clinical-stage therapeutic candidates.

Todd Krueger, CEO of AOBiome Therapeutics, spoke exclusively to The Silicon Review on how his company is developing clinical-stage therapeutics designed for addressing a broad range of inflammatory conditions.

Interview Highlights

Q. Have you always been passionate about the biotech industry? And tell us what inspired the creation of AOBiome Therapeutics.

As a person whose last science class was high school physics, I became passionate about health and wellness through my own experience. About the time I underwent open-heart surgery at age 30 to fix a congenital defect, I joined Gajus Worthington and Steve Quake to start Fluidigm, a company working to take technology from the Microchip industry and apply it to life sciences in disruptive applications. AOBiome has a parallel. Societies that live traditionally close to nature, avoiding modern hygiene and spending time in nature don't have the same level of incidences of inflammatory conditions that we find ourselves in as a society. Acne, eczema, rosacea, asthma, and rheumatoid arthritis, are not evolutionary diseases. The way we live has driven our disconnect from a natural healthy state. Our scientific founder made the link between the importance of ammonia oxidizing bacteria (AOB) and our immune system. AOBs are a critical piece of the nitrogen cycle that our bodies leverage to keep us healthy.

Q. What makes – and keeps – AOBiome relevant?

Our microbiome - the trillions of bacteria that populate our entire body has been dubbed "the largest organ in the body" - is critical to our immune system functioning properly. The importance of a healthy Gut microbiome is now well-proven and accepted; however, our Skin microbiome has not only been ignored, but it is also under constant assault from the soaps and preservatives present throughout our daily life. With this backdrop, disruptive product development in a new field is hard. There is no given path to follow. Pioneering can lead to dead ends. It has taken us a few years and a few miscues, but we have been able to hone the dose, the regimen, and the biological target, and we are now progressing into the final stage of drug development, Phase 3, to start treating patients in a natural, safe, manner. Our first target is mild-to-moderate atopic dermatitis (eczema) with associated moderate-to-severe pruritus (itch). We believe that over the next few years, more and more therapies will break through using this new learning.  The microbiome is on a more accelerated path, and with our clinical results in Eczema, Itch, Acne, and Rosacea, we are among the first to demonstrate its true promise.

Q. How do AOBiome-developed therapies transform human health?

Our patented biologic, a naturally derived bacteria that has been eliminated from our skin through the use of preservatives in soaps and shampoos, plays a significant role in regulating several critical immune pathways. AOBs down-regulate Interleukins (ILs) 4, 5, 13, and 31. Those pathways are all hallmarks of an overactive immune system that drives diseases such as atopic dermatitis and associated pruritis. As our AOBs oxidize the ammonia naturally found on our skin and produce nitric oxide (anti-inflammatory) and nitrite (anti-infective), they also vaso-dilate and eliminate populations of harmful bacteria (p-acnes, Staphylococcus aureus, etc.). Conditions such as acne, infection, and wound healing can be targeted by re-populating the skin with this critical bacteria. Nitric oxide has been long recognized for its importance in wound healing; however, the challenge has been delivery and dosage - problems solved by our drug.

Q. How responsive is AOBiome to the changing needs of patients?

The drug industry has become focused on a very small corner of the market. Pharma is now focused on small populations severe disease where  companies can charge exorbitant prices and market to a handful of doctors has been a trend in the last decade. This leaves everyone suffering from milder versions of the same disease with poor choices, where innovation isn't even attempted. Some drugs for milder disease conditions have "acceptable" side effects for lack of other alternatives and, frankly, very often don't work well. For example – long-term exposure to topical steroids is not recommended for various reasons, especially for kids. We are interested in providing safe and effective first-line therapy to that massive but mostly ignored population.

Q. Will AOBiome be expanding, and conducting any new research programs that we should be aware of?

The company recently read out positive results in its 547 patient Phase 2b clinical trial for mild-to-moderate atopic dermatitis (eczema) patients with moderate-to-severe pruritus (itch). We achieved positive results for both endpoints. The company is working through its end of Phase 2 process to ramp up for a Phase 3 trial. We hope to start the trial in 2023. We are also looking at additional indications such as acne and rosacea, which we have run previously with promising results.

Q. About the future, where do you see AOBiome a couple of years from now?

We envision the company as a leader in the space of dermatology, not just the microbiome. At the end of the day, patients are interested in safe and effective medicines, especially ones that are easy to apply and don't interfere with their lives.

Q. What is your final message to The Silicon Review readers, your current and future clients and partners?

As a platform company, we assume that we will eventually partner with a large pharmaceutical company that is already serving our target populations, not just dermatologists. Additionally, we see our unique safety profile as important to pediatricians and internists, who are on the front lines of disease and are less comfortable prescribing drugs targeting severe diseases with riskier side effects. The markets we are addressing are massive and rapidly growing as more patients enter a world of increased inflammation.

The Visionary Leader Upfront

Todd Krueger is the President, Director, and Chief Executive Officer of AOBiome Therapeutics. He is primarily responsible for the overall management, corporate development, and strategic planning of the company and has been with the company since 2015. Mr. Krueger has over 25 years of experience in healthcare strategy, business development, operations, and finance.

Mr. Krueger graduated from Northwestern University, United States, with a Bachelor of Economics degree with Highest Distinction, and earned his Master of Business Administration degree from the Kellogg School of Management, Northwestern University, United States.

“AOBiome Therapeutics recently read out positive results in its 547 patient Phase 2b clinical trial for mild to moderate atopic dermatitis (eczema) patients with moderate to severe pruritus (itch). It achieved positive results for both endpoints.”