A possible new therapy for psoriasis has shown promise, a European conference has heard.
A phase 1b clinical study shows the first clinical evidence that modulating systemic inflammation can be treated orally with a non-living single strain commensal microbe, researchers say.
The findings of the study, which were presented at a conference of the European Academy of Dermatology and Venereology, evaluated EDP1815, an orally-delivered investigational therapy that is being developed for treatment of inflammatory diseases but has never been used for a human disease before.
Researchers tested a preparation of a non-living single strain of the bacterium Prevotella histicola, isolated from the small intestine of a human donor, in two cohorts of 12 and 18 patients with mild to moderate psoriasis for 28 days, with follow-up off treatment through 42 days.
Early results showed that EDP1815 was well tolerated at daily doses of up to 8.0×101 cells administered for up to 28 days.
At day 28, the mean percentage reduction in Psoriasis Area Severity Index (PASI) score for both EDP1815 cohorts was 16%, compared to 1% for the placebo cohorts. There was an improvement to 21% in the high-dose cohort at day 42, but not the low dose cohort (10%) or placebo cohorts (3%), indicating sustained and ongoing clinical effect at the higher dose.
The mean reduction in Lesion Severity Scores (LSS) at 28 days were 15% and 23% in the high- and low-dose cohorts, respectively, compared to a 1% increase from baseline in the placebo group. Again, further clinical improvement, to a 24% reduction, was seen in the high-dose cohort.
Dr Douglas Maslin, of Addenbrooke’s Hospital in Cambridge, UK, said: “Although several treatments options are available for psoriasis patients with the most severe disease, there is a great need for new innovative methods for those living with mild-moderate disease.
"It is a real breakthrough, especially as we have seen from the pre-clinical and phase I trials that it was well tolerated with no overall difference from placebo and with no severe side effects reported. We are extremely encouraged to see that these data support further clinical development of EDP1815 in psoriasis. We are already in phase II clinical trials across the UK, Poland and US. This is a potentially massive win for the majority of psoriasis patients, as it has the potential to improve treatment options and perhaps change the current standard of care.”
* EADV Virtual will also hear from Italian researchers who found that biologics increase the risk of COVID-19 infection in psoriatic patients but could protect them from ICU hospitalisation and death.
The study compared 1,193 adult psoriatic patients receiving biologics and small molecules at San Donato Hospital in Milan with the population in Lombardy from 21 February 2020, when the first COVID-19 case was recorded in Italy, to 9 April 2020.
Compared with the general population of Lombardy, patients receiving biologics were at higher risk of testing positive for COVID-19 (unadjusted OR 3.43 [95%CI 2.25-5.73], p<0.0001), being self-quarantined at home (OR 9.05 [95%CI 5.61-14.61], p<0.0001) and being hospitalised (unadjusted OR 3.59 [95%CI 1.49-8.63], p=0.0044).
However, their risk of being admitted to ICU (unadjusted OR 3.41 [95%CI 0.21-54.55], p=0.3861) and of dying (unadjusted OR 0.41 [95%CI 0.03-6.59], p=0.5306) were not statistically significant.
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