Enrollment of Phase III Clinical Study Is Complete for Trogarzo Intramuscular Injection (IM)
· Issued by TaiMed Biologics Inc.
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Provided by: TaiMed Biologics Inc.
SEQ_NO
3
Date of announcement
2022/04/27
Time of announcement
21:46:35
Subject
Enrollment of Phase III Clinical Study Is Complete
for Trogarzo Intramuscular Injection (IM)
Date of events
2022/04/27
To which item it meets
paragraph 53
Statement
1.Date of occurrence of the event:2022/04/27
2.Company name:TaiMed Biologics Inc.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):Head Office
4.Reciprocal shareholding ratios:N/A
5.Cause of occurrence:
TaiMed reached an agreement with Theratechnologies on May 18, 2021 to
officially start a phase III clinical trial of Trogarzo IM injection to
further expand the use of the drug in multi-drug resistant patients in the
United States and Europe. The clinical trial, regulatory application and
other related costs are all borne by Theratechnologies, and the terms in
the original license agreement remain unchanged..
The enrollment of the Phase III clinical study of Trogarzo IM is officially
complete per study protocol. The clinical trial data are expected to be
available by the end of the third quarter of 2022 after statistical
analysis. A supplemental biologics license application (sBLA) for Trogarzo
IM will be submitted to the US FDA in the fourth quarter of 2022 if the
primary endpoint is met.
6.Countermeasures:None
7.Any other matters that need to be specified:
New drug development requires a long process and sizeable investments with
no guarantee of success, which therefore may pose substantial investment
risks. Investors are advised to exercise caution and conduct thorough
evaluation.
