3rd March, 2020
– Destiny Pharma issued an announcement,
which is summarized as follows:
Phase IIb study on track to complete recruitment in mid-2020
Earlier grant funded programs progressing to plan
Company well-funded through to mid-2021
The Company’s ongoing Phase IIb clinical trial of its lead
asset, XF-73 (exeporfinium chloride) nasal gel, is testing XF-73 as a novel
drug for the prevention of post-surgical infections caused by Staphylococcus
aureus (SA), including the superbug variant methicillin-resistant S.aureus
(MRSA). US, EU and WHO surgical guidelines are recommending this type of
treatment to tackle nasal SA/MRSA bacterial carriage in all high risk surgeries
and the Company forecast peak US sales of $US 1 billion driven by the
appropriate use of XF-73 in millions of eligible surgical procedures.
The Phase IIb trial remains on track to complete patient
recruitment in mid-2020 despite slower than planned recruitment over the last three
months. To date, Destiny Pharma has opened 15 of the targeted 23 hospital
clinical trial sites in the US and Europe to enable the recruitment of 200
open-heart surgery patients as required under the Investigational New Drug
Application opened in 2019. A total of 60patients have so far been successfully
recruited and enrolled in the study.
As previously reported, recruitment has been slower than
planned in the US, but good progress was made in European sites in the second half
of 2019. During Q4 2019, the European recruitment rate slowed due to a
shortfall in eligible cardiac surgery procedures in one country. This was
driven by changes in government hospital reimbursement for cardiac surgeries
and had no connection with the XF-73 clinical trial protocol. The situation was
resolved in January 2020 and patient screening and recruitment has returned to
plan. Destiny Pharma is also opening further clinical sites and an additional
European country to boost recruitment. As a result, the Company now expects to
report an interim safety, efficacy and futility analysis, that will be
conducted by an Independent Safety Monitoring Board, during Q2 2020. Full Phase
IIb study data will be available after recruitment completes in mid-2020.
Destiny Pharma’s four grant funded programmes researching the
potential of compounds from the XF drug platform in dermal, respiratory, ocular
and biofilm related infections are progressing to plan and updates will be
announced during 2020.
Destiny Pharma had an unaudited cash position of ￡7.5 million
as at 31 December 2019, which will provide a cash runway through to H12021.
Destiny Pharma expects to report its audited financial results for the year
ended 31 December 2019 in April 2020.
Original website Link:
https://www.destinypharma.com/2020/03/03/03-mar-2020-clinical-and-business-update/