OliX Pharmaceutical said it plans to submit an investigational new drug application for OLX301A, a dry and wet age-related macular degeneration (AMD) treatment, in the second half of this year after confirming its efficacy.
The announcement comes after the company presented its preclinical trial data for the treatment at “TIDES; Oligonucleotide and Peptide Therapeutics,” held in San Francisco, Calif., from Tuesday to Thursday.
The test included 16 rhesus monkeys, which have the most similar genes to those of humans. The company induced wet age-related macular degeneration on the monkeys and confirmed that a single administration of the treatment maintained its efficacy for more than 56 days (eight weeks).
“We are very pleased to have confirmed preclinical study results that surpassed our expectation,” OliX CEO Lee Dong-ki said. “Based on the result of the study, the company expects to achieve a similar or more superior efficacy during the phase 1 clinical trial, scheduled for the second half of this year.”
AMD, diagnosed as either dry or wet, is a symptom where the retina and deeper layers of the eye deteriorate, which can lead to a loss of eyesight. While effective therapies for wet AMD exist, the treatment may result in less than optimal vision outcomes for many patients over time. There is no cure for dry AMD now.
OliX said its OLX301A program is a first in class treatment which cures both wet and dry AMD. The company signed license and collaboration agreement with Théa Open Innovation, a part of Laboratoires Théa S.A.S, in March.
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