Gorodenkov
Abouna Remedies (Nasdaq: ABEO) reported additional data from a phase 3 trial of EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) at the International Societies for Investigative Dermatology (ISID) meeting in Tokyo.
Epidermolysis bullosa is a rare condition that causes blistering of the skin. the Wounds can be caused by a minor injury, even from heat, rubbing, or scratching and cause pain.
“Following the positive VIITAL study results reported in November 2022, additional data reported in ISID further highlight the proposed value of EB-101 by demonstrating improved wound healing and reduced pain at 6, 12, and 24 weeks compared to EB-101 wounds. Take control after a one-time EB-101 application,” said Abeona CEO Vish Seshadri.
Dubbed VIITAL, the third phase achieved its major targets, which were reported in November 2022.
Both initial joint goals were met, the company said Thursday, with 81.4% of wounds treated with EB-101 showing 50% healing, compared to 16.3% of untreated control wounds at six months.
In addition, a significant reduction in pain intensity was observed 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, as well as pain reduction, was greater for those with EB-101 and achieved statistical significance over untreated control wounds.
The company noted that patient-reported results of itching and soreness showed significantly greater improvement with EB-101.
Provider-reported outcomes related to wound care and overall impression of wound pain have shown consistent trends of improvement, according to the company.
EB-101 has been shown to be well tolerated with no serious adverse events associated with treatment.
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