Aldeyra Therapeutics Inc (NASDAQ:ALDX) has gained more than half its previous market value so far today, currently up $2.35 and trading at $6.60 – a 55 percent boost. Before the opening bell this morning, the pharmaceutical developer announced positive data from a Phase 2a clinical study evaluating its dry eye disease therapy, a topical drug called ADX-102.
Dry eye disease is a continuously challenging condition for a lot of people across the globe, with about 20 million people affected in the United States alone. The inflammatory disease causes less-than-sufficient moisture and lubrication of patients’ eye surfaces – leading to inflammation, dryness, irritation, pain, discomfort, and (in extreme cases) impaired vision. The current standard treatments for dry eye disease are inadequate, according to Aldeyra.
A contributing factor to eye inflammation, Aldeyra says, may be pro-inflammatory aldehyde mediators – which are relieved by the company’s novel topical aldehyde trap platform. This approach reduces aldehyde levels, introducing a new treatment option that could help millions of people alleviate their dry eye disease symptoms worldwide.
In the Phase 2a study reported on earlier this morning, researchers observed three different formulations of ADX-102 in a total of 51 patients suffering from dry eye disease. After a 29-day period of treatment and observation, the drug managed to show a statistically meaningful improvement in symptoms – using a number of scoring systems.
Symptom improvement was observed after just one week of being on the novel treatment, and levels of aldehyde were found in significantly less quantities after observing the patients’ tears.
“The breadth of activity across noninfectious anterior uveitis, allergic conjunctivitis, and now dry eye disease confirms the potential of ADX-102 as an important and differentiated therapy in ophthalmology,” said the company’s President and Chief Executive Officer, Todd C. Brady, MD, PhD. “We are particularly excited about the potential of ADX-102 in the dry eye disease population, which is generally perceived to be inadequately treated but accounted for approximately $1.8 billion in prescription sales in the United States in 2016.”
On top of the impressive results announced this morning, there were no safety issues observed for any of the three ADX-102 formulations that researchers evaluated – and no adverse events were recorded.
The main goal of the study was to find a formulation and dose range for the next phase of the clinical program, a Phase 2b trial. Based on the patient response spanning several sign and symptom endpoints, a 0.1% ophthalmic solution of ADX-102 was selected to move forward to the next step of clinical development. According to Aldeyra, they will begin the Phase 2b study in the first half of next year.
The author of this article holds no position in any of the companies mentioned above.