FM November2020 Digital P

US FDA
nod to start
phase 2
study of
FSD201
The US FDA has authorised the initiation of a phase
2 study for the use of FSD201 (ultramicronized
palmitoylethanolamide, or ultramicronized PEA) to treat
COVID-19, FSD Pharma said.
The FSD201 COVID-19 trial is a randomised, controlled,
double-blind, multicentre study, conducted on 352 patients
to assess the efficacy and safety of FSD201 dosed at 600mg
or 1200mg twice-daily, together with the standard of care
(SOC) compared to SOC alone in hospitalized patients with
documented COVID-19 disease. Eligible patients will present
symptoms consistent with influenza/coronavirus signs (fever,
dry cough, malaise, difficulty breathing) and newly documented
positive COVID-19 disease.
The primary objective of the FSD201 COVID-19 Trial is to
determine whether FSD201 plus SOC provides a significant
improvement in the clinical status of patients (e.g., shorter time
to symptom relief).
Secondary objectives of the FSD201 COVID-19 Trial include
determining whether FSD201 plus SOC demonstrates additional
benefit in terms of safety, objective assessments such as
length of time to normalization of fever, length of time to the
improvement of oxygen saturation and length of time to clinical
progression, including the time to mechanical ventilation or
hospitalization, and length of hospital stay. The exploratory
endpoint is cytokine clearance as measured by Enzyme-
Linked Immunosorbent Assay (ELISA).
The treatment period for patients in the FSD201
COVID-19 trial is 14 days and the primary
endpoint is determined at 28 days.
Regeneron’s REGN-COV2 antibody cocktail cuts viral levels
Regeneron Pharmaceuticals Inc
announced the first data from a
descriptive analysis of a seamless phase
1/2/3 trial of its investigational antibody
cocktail REGN-COV2 showing it reduced
viral load and the time to alleviate
symptoms in non-hospitalised patients
with COVID-19. REGN-COV2 also showed
positive trends in reducing medical
visits.
The ongoing, randomized, doubleblind
trial measures the effect of adding
REGN-COV2 to usual standard-ofcare,
compared to adding placebo to
standard-of-care.
The descriptive analysis included the
first 275 patients enrolled in the trial
and was designed to evaluate anti-viral
activity with REGN-COV2 and identify
patients most likely to benefit from
treatment; the next cohort, which could
be used to rapidly and prospectively
confirm these results, has already been
enrolled.
Patients in the trial were
randomized 1:1:1 to receive a one-time
infusion of 8 grams of REGN-COV2 (high
dose), 2.4 grams of REGN-COV2
(low dose) or placebo. All patients
entering the trial had laboratoryconfirmed
COVID-19 that was
being treated in the outpatient
setting. Patients were prospectively
characterized prior to treatment by
serology tests to see if they had
already generated antiviral antibodies
on their own and were classified
as seronegative or seropositive.
Approximately 45% of patients were
seropositive, 41% were seronegative
and 14% were categorized as “other”
due to unclear or unknown serology
status.
THE ANTIBODY
The anti-viral activity with
REGN-COV2 was analysed in
275 patients enrolled in the trial
INFUSION
45% 41% 14%
among them were
found seropositive
were
seronegative
were categorised
as "other"
20 / FUTURE MEDICINE / November 2020