Fortrea hired to run trials of sleep apnea drug
Labcorp spinoff Fortrea will run a mid-stage trial of a sleep apnea drug developed by Australian biotech Incannex Healthcare.
The contract – financial details of which were not disclosed – will see Fortrea manage the IND opening Phase II/III clinical trial investigating the candidate - IHL-42X – as a treatment for people suffering obstructive sleep apnea (OSA).
According to Incannex there are no registered drug treatments available to people with OSA, which means IHL-42X represents a “major economic opportunity” should the study achieve its endpoints as in the proof-of-concept trial.
Fortrea has already completed a 12-week feasibility study where the trial design was provided to potential investigators along with a survey to gauge interest in conducting the study and identify any region-specific regulatory hurdles.
Of the 195 trial sites contacted during the feasibility stage 63 expressed interest in participating in the IHL-42X study. Of these Incannex wants 45 to be included in the Phase II/III study.
Incannex’ CEO, Joel Latham, cited both the performance of the drug and Fortrea’s work on the proof-of-concept study as key to the continuation development program.
“These results were truly remarkable and now allows for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial […] Fortrea has been a valuable partner to Incannex for a long time over multiple projects and we have full confidence that its team will successfully manage this very important trial.”
He added that Fortrea’s familiarity with the study and established relationships with potential trial sites will expedite the study start up and site engagement activities.
According to a press statement “Fortrea will use its high-value data sets, combined with its technology enabled clinical trial solutions to improve study recruitment, reduce study risk, safeguard data quality, and gain operational insights as the trial progresses.”
The contract is the first to be announced since Fortrea completed its separation from Labcorp earlier this month.
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