Tissue Repair’s (ASX:TRP) wound healing drug cleared by FDA

• Tissue Repair’s (TRP) wound healing drug has been cleared by the US Food and Drug Administration (FDA) to enter its third phase of trials
• The company is fully funded for its drug, TR-987, to undergo a final review ahead of patient enrolment before the end of the year
• Over 15 sites have been approached across the US and Australia to hold the trial, involving a total of 600 participants
• Meanwhile, TR is developing a post-procedural topical gel, TR Pro+, to promote healing and improve skin condition after cosmetic procedures
• TRP traded 12 per cent higher at 28 cents at 3:25 pm AEST

Tissue Repair’s (TRP) wound healing drug has been approved by the US Food and Drug Administration (FDA) to enter its third phase of testing after completing its phase two trials.

Tissue Repair reported it’s fully funded for its the drug, TR-987, to enter the new phase of trials, and will undergo a final review by the FDA to propose clearance for patient enrolment by the end of the year.

Over 15 sites have been approached across the US and Australia to hold the phase two studies, involving a total of 600 participants.

Each of the trials will see participants from the US and Australia treated over 16 weeks, with the goal of reducing the size of patients’ venous leg ulcers.

“It is a big milestone to enter phase three and to be fully funded to complete it, a milestone achieved by a super talented and driven team,” TR Co-Founder Tony Charara said,

“Achieving an FDA-approved new drug label is a very valuable prize.”

The company says if trials of TR-987 are successful, it would be the first drug approved for venous leg ulcers in over 25 years.

The company is also developing post procedural topical gel, TR Pro+, to promote healing and improve skin condition after cosmetic procedures.

TRP traded 12 per cent higher at 28 cents at 3:25 pm AEST.