Aldeyra Therapeutics Inc. (ALDX:NASDAQ) announced topline results from the Phase 3 GUARD trial of its drug candidate, ADX-2191, in proliferative vitreoretinopathy, and they were "encouraging," reported Laidlaw & Co. analyst Dr. Yale Jen in an October 6, 2022 research note.
"We view Aldeyra shares as underexposed and undervalued," wrote Jen.
"We view the news very positively as it is a former confirmation of ADX-2191's effect in treating proliferative vitreoretinopathy," Jen wrote.
Considering the news, Laidlaw reiterated its Buy rating and US$30 per share target price on Aldeyra, the current share price of which is about US$5.58. The gap between the two prices implies a significant potential return for investors.
"We view Aldeyra shares as underexposed and undervalued," wrote Jen.
Recap of Results
As for the GUARD Part 1 trial results, the analyst highlighted that they suggest ADX-2191 treatment could be safer and more effective in treating proliferative vitreoretinopathy than compounded methotrexate.
Specifically, in the Phase 3 study, Jen relayed that in the group randomized to ADX-2191, the primary endpoint was met of prevention of retinal detachment over six months (23.5%) with p=0.024, compared to historical control (38.7%). In the group randomized to routine surgical care, retinal detachment over six months was about 29%.
ADX-2191 also showed numerical superiority over routine surgical care in multiple secondary or exploratory endpoints, including visual acuity and central macular subfield thickness. The p-value for dichotomous endpoints, like epiretinal membrane appearance, was 0.047.
In terms of safety, Jen noted ADX-2101 was well tolerated. The most common adverse effect was mild to moderate punctate keratitis, experienced in 16% of patients. This incidence is much less than the 58% previously reported in compounded methotrexate studies.
What to Watch For
Next for Aldeyra and ADX-2191 is a Type C meeting with the U.S. Food and Drug Administration (FDA) in H1/23 to discuss the regulatory path for the use of this drug for proliferative vitreoretinopathy.
In the meantime, however, in Q4/22, the biopharma will meet with the FDA prior to filing a new drug application (NDA) for the same drug candidate for primary vitreoretinal lymphoma.
"A positive [pre-NDA] meeting should lead to an NDA submission soon," Jen wrote.
Also, in Q4/22, Aldeyra expects to file an NDA for reproxalap in dry eye disease.
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