Evelo Biosciences(US:EVLO)2021-10-28 16:28Financial Data and Key Metrics Changes - The company reported positive top-line results from a Phase II trial of EDP1815 in patients with mild and moderate psoriasis, demonstrating the potential of SINTAX medicines [7][8] - The Phase II clinical data indicated that EDP1815 has safety and tolerability comparable to placebo, supporting its advancement towards registration trials [8][26] Business Line Data and Key Metrics Changes - EDP1815 is positioned as a significant new medicine for treating psoriasis, addressing an unmet need for over 55 million patients worldwide, with mild and moderate cases representing over 90% of this population [8][9] - The Phase II trial showed that approximately 30% of patients achieved a PASI-50 response by the 16-week endpoint, with continuous distribution of responses suggesting potential for higher rates with longer treatment [21][22] Market Data and Key Metrics Changes - The global market for mild and moderate inflammatory diseases is substantial, with over 200 million people suffering from dermatological conditions and about 1 billion needing better treatments for broader inflammatory diseases [10][12] - The company aims to leverage the SINTAX platform to address a wide range of inflammatory conditions, potentially impacting millions of patients globally [15][35] Company Strategy and Development Direction - The company is focused on developing a new class of medicines that harness the SINTAX platform, aiming to transform healthcare rather than provide incremental improvements [12][35] - Future versions of SINTAX medicines are expected to reach biologic levels of efficacy in humans, with ongoing efforts to enhance drug delivery and formulation [33][34] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the potential of SINTAX medicines to drive clinical effects throughout the body, with ongoing studies expected to refine clinical plans and regulatory discussions [14][36] - The company is optimistic about the future of its EV development platform, anticipating significant advancements in the clinic and potential applications in neuroinflammation [43][70] Other Important Information - The company has lifted a clinical hold on the EDP1815 Phase II atopic dermatitis trial and expects to begin dosing in late Q4 2021 [38] - The TACTIC-E trial for COVID-19 treatment is progressing well, with recruitment nearing its initial goals [40][41] Q&A Session All Questions and Answers Question: Thoughts on regulatory path for atopic dermatitis using EASI-50 as primary endpoint - Management indicated that the bar is low for a safe, well-tolerated oral drug in atopic dermatitis, and they expect to see EASI-50 responses in a reasonable percentage of patients [45][48] Question: Comparison of cohort B and cohort A in psoriasis study - Management clarified that cohort B consists of the same patients from cohort A, and the data will inform the Phase III design moving forward [46][55] Question: Level of additional follow-up expected in Part B of psoriasis study - Management expects a significant number of subjects to complete the additional 20 weeks in Part B, with data to be reported in Q1 2022 [58][61] Question: Recruitment challenges for EDP1867 - Management noted that recruitment may have been impacted by COVID-19, particularly in the UK, and they are currently assessing the situation [60] Question: Enrollment of patients with comorbidities in atopic dermatitis study - Management stated that while they won't specifically recruit patients with comorbidities, they will analyze any data that emerges regarding these conditions [64][66] Question: Differences in profile between EDP1815 and EDP1867 - Management emphasized the need for human clinical data to determine similarities or differences in responses between the two drugs, with ongoing research into their distinct molecular backgrounds [67][70]