INTERVIEW: Evelo’s SINTAX medicines could address a broad range of inflammatory disorders

Evelo Biosciences (Nasdaq:EVLO) is a clinical-stage biotechnology company that is focused on a newly uncovered area of central human biology called the small intestinal axis, SINTAX, which governs many of the biological systems throughout the body, including inflammation. The Cambridge, Massachusetts-based company aims to address all stages of inflammatory diseases through its integrated profile of orally administered SINTAX medicines.

Evelo’s lead product candidate EDP1815 is currently being studied for a wide range of indications including psoriasis, atopic dermatitis, as well as hyperinflammation associated with severe COVID-19. The pipeline also includes a few other candidates – including one for oncology – in the early development or preclinical stages.

We had the opportunity to interact with Douglas Maslin, who is the Clinical Lead at Evelo Biosciences, where he elaborated on the clinical programs and the market potential of the firm.     

Your lead candidate EDP1815 is being studied for two very different indications – Psoriasis and Covid-19? How does that work? 

EDP1815 has a unique mechanism of action: it controls systemic inflammation through an initial interaction with the mucosal immune system in the small intestine. The effect is a broadly acting inflammation-resolving agent which has shown to have clinical effects in various diseases where inflammation is the underlying issue – including psoriasis and atopic dermatitis.

We were very excited to recently release positive results from Evelo’s Phase 2 study in mild and moderate psoriasis: proving our platform, and the idea that an oral non-living microbe could successfully resolve inflammation. EDP1815 is advancing towards registration in psoriasis, and a Phase 2 study of atopic dermatitis is shortly due to begin dosing.

With regards to COVID-19, EDP1815 was selected by external experts to be included in the TACTIC-E study: a Phase 2/3 international study of hospitalized COVID-19 patients. The profile of EDP1815 as an inflammation-resolving therapy may allow it to prevent the hyperinflammation associated with severe COVID-19, without overshooting and causing immunosuppression, so still allowing our natural anti-viral immunity to work. Data from the trial is expected in the first half of 2022, and depending on the outcome, Evelo may choose to explore EDP1815 as a treatment in other diseases in which hyperinflammation plays a role, such as influenza.

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How do you expect the vaccination rates and new virus variants to impact the demand for COVID-19 drugs?

The COVID-19 pandemic continues globally, with countries worldwide at different stages of the pandemic and with different access to life-saving vaccines and various treatments. Many experts believe that COVID-19 will become endemic and treatments that can prevent worsening of disease will be required alongside vaccination. An oral, affordable medicine with the potential to address the complex hyperinflammatory response seen in COVID-19, without also blocking the immune response required to fight off the ongoing viral infection, would be a very useful treatment against this virus. Another advantage to using a potential product like EDP1815 is that it is orally administered, and no systemic exposure is observed – limiting the potential for drug or other disease interactions.

Do you have any estimated timeline and market potential for EDP1815 for psoriasis?

Following the positive results of the Phase 2 study released in September 2021, we are advancing regulatory discussions. Based on the outcome of these discussions, we plan to initiate our registrational studies in psoriasis and will release an updated timeline at that point.

The market potential for EDP1815 in psoriasis is vast. In short, our assessment of the existing and future landscape suggests that there remains a significant need for oral medicines that are safe, effective, well-tolerated and affordable for the hundreds of millions of people suffering from psoriasis around the globe, especially for people with mild and moderate disease.  This is a need that we believe EDP1815 is uniquely positioned to address given many of its features, including its placebo-like safety and tolerability profile, which surveyed dermatologists indicate is the most important therapy attribute for them.

All the systemic therapies that have been launched recently are targeted towards patients with moderate to severe disease. In fact, in the US – which has better access to innovative therapies relative to other regions in the world, fewer than 8% of patients with psoriasis receive these treatments.

Looking at Evelo’s platform, it is important to note the broader potential for SINTAX medicines. Inflammation is the major driver of most chronic diseases.  These range from inflammatory bowel disease, asthma, food allergy, common dermatological diseases such as atopic dermatitis and psoriasis, arthritic conditions such as rheumatoid arthritis to name just a few.  Overall, there are about a billion people globally who suffer from these types of inflammatory diseases.  While the data to date is in psoriasis and atopic dermatitis, we are not a dermatology company and we see great potential for SINTAX medicines, not only in our initial indications, but also across a broad spectrum of inflammatory diseases.  It is our intention to explore and capture the full breadth of opportunity for SINTAX medicines across inflammatory diseases.

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You have a drug candidate for oncology in the pre-clinical stage. What types of cancers are you targeting and how is it going to be different from what’s currently available in the market?

We haven’t released any information on what indication we would be targeting for our oncology pre-clinical candidate.

Given that your R&D costs are likely to increase, how comfortable are you with your current cash balance?

We believe we have the necessary capital to move through multiple key upcoming milestones, as well as our ongoing efforts in COVID-19.

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