【Destiny Pharma-Product XF-73】Update on Phase 2b Clinical Study of Lead Asset XF-73 in the Prevention of Post-Surgical Bacterial Infections

Partner News

27th July, 2020
– Destiny Pharma
issued an announcement,
which is summarized as follows: 

Protocol amendment
agreed with FDA to reduce Phase 2b study size without compromising its
statistical power or clinical value

Study two thirds
enrolled. Recruitment now expected to complete by year end

Planned study interim
safety review to be announced in August 2020

Destiny Pharma
announces that a clinical protocol amendment has been agreed with FDA for its
ongoing phase 2b study of lead asset XF-73.The study is evaluating XF-73, as a
nasal gel, for the prevention of post-surgical hospital infections caused by
Staphylococcus aureus bacteria, such as MRSA. The agreed amendment recognizes
the impact COVID-19 has had in slowing patient recruitment in clinical studies
since March and the FDA’s willingness to support certain protocol amendments
that help to accelerate the completion of ongoing clinical trials but do not
compromise a study’s integrity and clinical objectives.

The amendment to the
protocol incorporates a change to the primary patient population where the
primary endpoint for the study will be measured. The primary microbiological
end point post-surgery will now be measured in those patients who had a
positive load of nasal Staphylococcus aureus before receiving the study
treatment. This contrasts to the original primary
population, which included all randomised patients regardless of their baseline
nasal load of Staphylococcus aureus. Very importantly, this change enables
a reduction in the prospectively defined study size from 200 patients to 125
while maintaining the statistical power of the study and its clinical value.
This preserves the potential of the trial results to be a key step towards the
Phase 3 clinical trial programme of XF-73. Destiny Pharma has informed all
appropriate regulatory bodies and ethics committees involved. Other protocol
modifications agreed with the FDA regarding study procedures will also make it
easier for hospitals to recruit and retain hospital patients.

Destiny Pharma
expects that as the incidence of COVID-19 continues to decline in European
hospitals they will begin recruiting patientsinto the study again and that
recruitment into US study sites is likely to lag, given the higher infection
incidence. That said, the study hasalready enrolled 77 patients out of the new
target of 125 and the Company expects to have over 20 sites open in three
countries activelyrecruiting the remaining patients in the next few months with
the majority of these being FDA-compliant sites in Europe. The study remainson
track to complete recruitment by the end of 2020. The result of a planned
interim safety review by the study’s Independent SafetyMonitoring Board is
expected to be announced in August 2020.

Original website Link: