2023-05-11 08:44:10 ET
Abeona Therapeutics ( NASDAQ: ABEO ) reported additional data from a phase 3 trial of EB-101 to treat recessive dystrophic epidermolysis bullosa (RDEB) at the International Societies for Investigative Dermatology (ISID) Meeting in Tokyo.
Epidermolysis bullosa is a rare condition which causes fragile, blistering skin. The wounds can happen due to minor injury, even from heat, rubbing or scratching and causes pain.
"Following the positive topline VIITAL study results reported in November 2022, the additional data reported at ISID further highlights the value proposition of EB-101 by demonstrating improved wound healing and pain reduction at 6, 12 and 24 weeks compared to control wounds following a one-time application of EB-101," said Abeona CEO Vish Seshadri.
The phase 3 trial dubbed, VIITAL, had met its main goals, which were reported in November 2022.
The company said on Thursday that both co-primary goals were met, with 81.4% of EB-101–treated wounds showing ?50% healing, compared to 16.3% of untreated control wounds at six months.
In addition, a significantly greater reduction in pain severity was seen with EB-101 (3.07 mean pain reduction from baseline), compared to untreated control wounds (0.90 mean pain reduction) at six months.
At weeks 6 and 12, the percentage of wounds with ?50%, ?75% and complete healing, plus pain reduction, was greater for those on EB-101 and achieved statistical significance over untreated control wounds.
The company noted that patient-reported outcomes related to itch and blistering showed significantly greater improvement with EB-101.
Caregiver-reported outcomes related to wound care and overall impression of wound pain demonstrated consistent trends for improvement, according to the company.
EB-101 was shown to be well-tolerated with no serious treatment-related adverse events seen.
ABEO +5.94% to $3.39 premarket May 11
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Abeona stock rises on new data for rare skin disorder drug EB-101