Azitra: Revolutionizing Skin Disease Treatment

In this interview, Francisco Salva, CEO of Azitra, shared insights into the company’s innovative approach to treating skin diseases. Azitra is pioneering the use of engineered living organisms to address rare conditions like Netherton syndrome and ichthyosis vulgaris. By integrating advanced technologies, including artificial intelligence, Azitra hopes to set new dermatological treatment standards. Francisco discussed the company’s unique methodologies, current clinical trials, and challenges in this specialized field.

Moe: Francisco, how did Azitra’s founding insights shape your current pipeline and strategy?

Our cofounders, Azim Munivar and Travis Whitfill, were inspired by the potential of using the skin’s natural microbiome to deliver therapeutic proteins. This revolutionary idea allowed us to bypass the skin’s protective barrier, the stratum corneum, which is typically impermeable to proteins and large molecules. Initially, we focused on a large protein called filaggrin, which is crucial for skin health. Although challenging, this work laid the foundation for our current pipeline. Today, we’re applying this technology to genetically engineer microbes that can deliver proteins, peptides or small molecules directly into the skin, targeting diseases like Netherton syndrome, where patients suffer from severe skin issues due to genetic mutations.

Moe: How does Azitra’s mechanism of action differentiate your products from traditional therapies?

Our platform is distinct because it utilizes the skin microbiome to deliver treatments. Unlike traditional topical protein therapies that struggle to penetrate the skin’s outer layer, our engineered microbes can colonize beneath the stratum corneum. This allows them to produce and deliver therapeutic proteins directly where needed. For instance, in Netherton syndrome, our microbes produce a protease inhibitor that helps maintain skin integrity. We’ve also integrated artificial intelligence to enhance our understanding of these microbes, predicting their capabilities and products as well as refining our drug development process. This combination of biotechnology and AI sets us apart and accelerates our ability to bring effective treatments to market.

Moe: What are the benefits and challenges of targeting rare diseases like Netherton syndrome?

Targeting rare diseases offers several advantages, particularly the potential for accelerated approval pathways, which are crucial in the current biotech environment. These pathways allow us to bring treatments to patients more quickly, which is a significant advantage given the unmet needs in these areas. While we plan on exploring broader applications, such as atopic dermatitis in the future, our immediate focus remains on these rare conditions. This strategy aligns with our mission to address significant unmet medical needs and positions us to leverage our technology effectively. The challenges include patient recruitment and navigating the unique dynamics of dermatology sites, which differ from other therapeutic areas.

Moe: Can you provide more details on the Phase 1 trial for ATR-12 in Netherton syndrome?

The Phase 1 trial for ATR-12 is designed as a rigorous proof of concept. We’re conducting a 14-day treatment where one side of the patient’s body receives the active drug and the other a placebo. This intra-patient comparison helps us control for variability and gain clear insights into the drug’s effects. We’re primarily focused on safety and formulation, with plans to extend to a longer Phase 2 trial. Additionally, we’ve developed biomarker assays to assess biological activity, which will provide valuable data on the drug’s mechanism of action. This trial is crucial for demonstrating the potential of our technology and setting the stage for future clinical development.

Moe: How is Azitra navigating the challenges of running trials in rare dermatological diseases?

One of the main challenges is patient recruitment, as these conditions are rare. Additionally, dermatology sites operate differently from oncology sites, with more variability in patient scheduling. To navigate these challenges, we’ve brought on experienced professionals like Dr. Mary Spellman, our CMO, who has extensive experience in dermatology trials. Her expertise is invaluable as we transition from research to clinical development. We’ve learned the importance of flexibility and adaptability in trial design and execution, which are critical for success in this field. By sharing these insights, we hope to contribute to the broader conversation on advancing treatments for rare diseases.