Aldeyra Therapeutics enrolled the first patient in their Phase 3 clinical trial of ADX-102.
Aldeyra Therapeutics (NASDAQ:ALDX) enrolled the first patient in their Phase 3 clinical trial of ADX-102 treating noninfectious anterior uveitis, with results expected by the latter half of 2018.
As quoted in the press release:
“Based on positive results from our Phase 2 clinical trial announced last year, we are excited to commence Phase 3 clinical testing of our novel aldehyde trap, ADX-102, in noninfectious anterior uveitis,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “NAU is a rare and potentially blinding ocular disorder that affects an estimated 150,000 patients in the United States. In contrast to corticosteroids, which are often used to treat NAU, ADX-102 does not appear to cause increases in intraocular pressure — a precursor to glaucoma — and thus may represent a safer therapeutic option than the current standard of care.”
ADX-102 and other product candidates generated from Aldeyra’s aldehyde trap platform sequester and facilitate the degradation of aldehydes, a class of endogenously generated pro-inflammatory mediators. In a Phase 2 clinical trial in NAU, 0.5% topical ocular ADX-102 led to the resolution of inflammation to the same degree as corticosteroid therapy, but without the increases in intraocular pressure observed in corticosteroid-treated patients.
The Phase 3 clinical trial is expected to enroll up to 100 NAU patients with active disease, randomized equally to receive either 0.5% topical ocular ADX-102 or vehicle for four weeks. Consistent with the Phase 2 trial, the primary endpoint will be the resolution of inflammation. Results of the Phase 3 trial are expected in the second half of 2018.