|Over a month ago|
Evelo Biosciences upgraded to Buy on valuation at Chardan » 09:5011/0111/01/21
Chardan analyst Keay…
Chardan analyst Keay Nakae upgraded Evelo Biosciences to Buy from Neutral, citing valuation, noting that the firm's unchanged price target of $12 represents 33% upside from the current price of the stock. Data from part B of Evelo's phase 2 trial of EDP1815 for patients with mild and moderate psoriasis is expected in Q1 of 2022 and the company also recently presented "encouraging" preclinical data for EDP1867 for the treatment of neuroinflammatory diseases, Nakae noted.
Evelo Biosciences upgraded to Buy from Neutral at Chardan » 08:0211/0111/01/21
Chardan analyst Keay…
Chardan analyst Keay Nakae upgraded Evelo Biosciences to Buy from Neutral with a $12 price target.
Evelo Biosciences announces expected milestones » 07:0810/2810/28/21
EDP1815 - Psoriasis: data…
EDP1815 - Psoriasis: data from Part B of the Phase 2 trial will report out in 1Q 2022 and Evelo anticipates presenting the full Phase 2 data set at a medical meeting or scientific congress during 2022. EDP1815 - Atopic Dermatitis: Evelo anticipates enrolling the first patients in the Phase 2 trial during 4Q 2021 and data from Phase 2 trial anticipated in 4Q 2022. EDP1867 - Atopic Dermatitis: Interim data from Phase 1b trial anticipated in 1H 2022. EDP2939 - Inflammation: Initiation of clinical development in 2022. EDP1908 - Oncology: Initiation of clinical development in 2022.
Evelo Biosciences reports Q3 EPS (63c), consensus (54c) » 07:0710/2810/28/21
"This was a pivotal…
"This was a pivotal quarter for Evelo. We reported positive Phase 2 clinical data for EDP1815 that clearly demonstrate we can harness SINTAX, the small intestinal axis, to drive meaningful clinical effects with an orally delivered medicine that had placebo-like safety and tolerability," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "We are advancing EDP1815 towards registration trials in psoriasis whilst continuing to advance our broader platform and our pipeline. This includes a Phase 2 clinical trial for EDP1815 in atopic dermatitis and an ongoing clinical trial for EDP1867. Our recently announced preclinical data for EDP1867 shows the potential of EDP1867 beyond atopic diseases."
Evelo Biosciences assumed with an Equal Weight at Morgan Stanley » 08:3210/1910/19/21
Morgan Stanley analyst…
Morgan Stanley analyst Vikram Purohit assumed coverage of Evelo Biosciences with an Equal Weight rating with a price target of $9, down from $13. While Purohit believes initial data for EDP1815 in psoriasis demonstrates an early signal, he would wait on detail on next-generation formulations of EDP1815, details for the pivotal study in psoriasis, and additional data from Evelo's pipeline to get more constructive.
Evelo Biosciences presents preclinical data for EDP1867 » 07:1310/1310/13/21
Evelo Biosciences presented preclinical data for EDP1867, a non-live pharmaceutical preparation of a single strain of Veillonella parvula, at ECTRIMS 2021, October 13-15, 2021. The data show that orally administered EDP1867 reduced disease severity and incidence of relapse in relapsing-remitting experimental autoimmune encephalomyelitis, EAE, mouse models of multiple sclerosis,MS, supporting the development of EDP1867 for the treatment of neuroinflammatory diseases. "These data suggest that the small intestinal axis, SINTAX, is an immune signaling portal to the central nervous system, CNS, opening up an entirely new pathway for treating neuroinflammation," said Mark Bodmer, Ph.D., President of R&D and Chief Scientific Officer of Evelo. "This striking observation shows that an orally delivered, gut-restricted SINTAX medicine overcomes blood-brain barrier limitations to drug delivery by harnessing the immune sensory connections between the small intestine and the CNS. This result complements our growing body of evidence in clinical and preclinical studies that SINTAX medicines have the potential to treat a wide range of systemic inflammatory conditions, without systemic exposure. The observation that it extends to the CNS suggests the potential for SINTAX medicines beyond the treatment of classical chronic inflammatory diseases to intractable neuroinflammation." In the preclinical study presented at ECTRIMS, EDP1867 was tested in a relapsing-remitting EAE mouse model of neuroinflammation. Oral daily treatment with EDP1867 administered prophylactically or therapeutically reduced the severity of disease as demonstrated by a decreased mean maximum score and a decreased incidence of relapse compared to placebo. Treatment with EDP1867 reduced inflammation and demyelination in the spinal cord as shown in histopathological analysis.
Evelo Biosciences price target lowered to $14 from $18 at Jefferies » 09:1609/2809/28/21
Jefferies analyst Chris…
Jefferies analyst Chris Howerton lowered the firm's price target on Evelo Biosciences to $14 from $18 and keeps a Buy rating on the shares after the company reported Phase 2 EDP1815 psoriasis data and said they believe they could further increase response rates by optimizing the formulation and release spec. While he sees the Phase 2 data as supportive of further development of '1815 in psoriasis, Howerton lowered his view on the odds of success in psoriasis and AD from 40% to 35% to reflect the need for additional formulation work and what he views the "modest efficacy" reported in the Phase 2 study.
Fly Intel: Pre-market Movers » 08:5809/2709/27/21
RCAT, GGPI, ASPU, BBIG, NRXP, FB, ASLN, EVLO, CAPR, OPK
Check out this morning's…
Evelo Biosciences announces data from EDP1815 study » 05:2909/2709/27/21
Evelo Biosciences announced data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the Psoriasis Area and Severity Index, or PASI, score, as measured by the proportion of patients achieving at least 50% improvement in PASI from baseline at the week 16 timepoint, was observed in the study. EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19. In the Phase 2 study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint was the mean percentage change in PASI between treatment and placebo and was prespecified as a Bayesian analysis. The Bayesian approach provides an estimate of the probability that EDP1815 is superior to placebo. The 16-week primary endpoint gave probabilities that EDP1815 is superior to placebo ranging from 80% to 90% across the prespecified analyses and cohorts. The responder endpoint reports the proportion of patients who had a meaningful clinical response, which is defined as PASI-50 or greater. 25% to 32% of patients across the three cohorts who were treated with EDP1815 achieved a PASI-50 at week 16 compared to 12% on placebo. In cohorts 1 and 2 this difference in response rate was statistically significant. Cohort 3 was directionally similar. The pooled PASI-50 response across all three EDP1815 cohorts, an exploratory analysis, was 29% vs.12% for placebo and was also statistically significant with a p-value of 0.027. An increase in the number of capsules of EDP1815 did not lead to a dose response. Additionally, several patients on EDP1815 achieved a PASI-75 or better, which was sustained or improved post treatment. For individuals who had a PASI-50 response or better, consistent effects in secondary and exploratory endpoints, including improvements in patient reported outcomes such as Dermatology Life Quality Index and Psoriasis Symptom Inventory, were observed. EDP1815 was observed to be well tolerated in the Phase 2 study. The safety data were comparable to placebo and consistent with what was previously reported in a Phase 1b study. Adverse events, or AEs, classified as "gastrointestinal" were comparable between active and placebo groups, with no meaningful differences in rates of diarrhea, abdominal pain, nausea, or vomiting. There were no related serious adverse events.
Evelo Biosciences issued U.S. patent for bacteria as medicines » 07:0509/0909/09/21
Evelo Biosciences announced that the USPTO has issued a new composition of matter patent for medicines comprising pharmaceutical compositions of Veillonella parvula bacteria. The issued claims in this new patent cover formulations of Veillonella parvula for oral administration, including EDP1867, which is currently in a Phase 1b clinical trial for the treatment of atopic dermatitis.