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A drug derived from a naturally occurring gut bacteria passed a proof-of-concept test by inducing modest reductions in psoriasis disease activity as a "topical" immunomodulator of the small intestine.

The mean Psoriasis Area and Severity Index (PASI) score decreased by 16% after 28 days of treatment with the drug, EDP1815. The degree of improvement increased to 21% at 42 days. In contrast, placebo treatment improved the PASI mean by 1%, Douglas Maslin, MD, of Addenbrooke Hospital in Cambridge, England, reported at the .

"EDP1815 is an oral medicine with broad action targeting inflammatory disease by targeting a physiological mechanism of control within the gut, leading to inflammation resolution," said Maslin. "These phase Ib results demonstrated safety and tolerability with efficacy at 4 weeks. This drug has the potential to address a significant unmet need in psoriasis and beyond."

EDP1815 is produced from a single strain of the human commensal bacteria Prevotella histicola, found in the duodenum of humans. In preclinical models, EDP1815 suppressed multiple proinflammatory cytokines. The drug modulates signaling from the small intestine to the immune system, exerting therapeutic effects without systemic absorption.

Maslin reported findings from a study of 30 patients with mild-to-moderate psoriasis (mean PASI score 6.7). Patient were randomized 2:1 to two different doses of EDP1815 or placebo and followed for 42 days. The PASI score decreased in response to both doses of the drug at 28 days, but additional improvement occurred only with the higher dose from day 28 to day 42.

Maslin said a phase II trial in patients with mild or moderate psoriasis and a phase Ib trial in atopic dermatitis have already begun. Clinical studies in other inflammatory skin diseases are planned.

Hair Growth with JAK Inhibitor

An oral Janus kinase 1/2 inhibitor maintained hair growth in a majority of patients with alopecia areata treated for more than a year, according to initial results from an ongoing open-label extension (OLE) of several phase II trials.

Patients treated with either of two doses of CTP-543 had 40-50% reductions from baseline in the Severity of Alopecia Tool (SALT) during the 24-week phase II trials. During the OLE, the mean improvement in SALT scores was maintained for an additional 24 to 28 weeks with the higher dose.

Patients enrolled in the phase II trials had moderate to severe alopecia areata associated with a mean SALT score of about 90, which declined to about 40 after 24 weeks. Patients originally treated with the lower dose of CTP-543 had additional improvement in SALT response after switching to the higher dose, said James Cassella, PhD, of Concert Pharmaceuticals in Lexington, Massachusetts. Only two of 152 patients who entered the OLE have had clear loss of response to treatment, he added.

To date, 130 patients have received CTP-543 for more than a year. The most common adverse events have been nasopharyngitis (19.7% patients), acne (17.8%), headache (7.9%), increased blood creatine phosphokinase (6.9%), and weight gain (5.3%). Most adverse events have been mild or moderate in severity. Of five serious adverse events, two were considered possibly related to treatment.

No Drop-Off in Acute STIs During COVID-19

The COVID-19 pandemic apparently had no impact on risky sexual behavior leading to acute sexually transmitted infections (STIs), data from an Italian study suggested.

From March 15 to April 14, during the initial pandemic surge in Italy, total visits to the two principal STI clinics in Milan decreased by 37% as compared with the same time period in 2019. The decline was almost entirely attributable to chronic infectious conditions, such as chlamydia and anogenital warts. The number of acute infections increased, including type II syphilis, gonorrhea, and Mycoplasma genitalium.

"It appears that the COVID-19 pandemic, despite lockdown and advice on social and physical distancing, did not inhibit risky behaviors," said Marco Cusini, MD, of Ospedale Maggiore Policlinico.

"While some STIs may have been contracted before the complete lockdown and became symptomatic during the quarantine, the number of acute STIs did not show a progressive decrease during the observation period. It is noted that the infections whose numbers increased, or remained unchanged, are those most associated with [men having sex with men]. It is paradoxical that infections have not markedly decreased with social distancing and lockdown," Cusini said.

The Italian findings contrast with a sharp decline in STIs in the United States from February to June. The number of expected cases of syphilis and gonorrhea declined significantly, along with other types of STIs, according to data presented at a on STI prevention.