United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced the enrollment of the first subject in the Phase IIa clinical study for its Category 1 drug, TUL12101 eye drops, in China. This development marks a significant step forward in the clinical evaluation of the drug.
The Phase IIa study is a multi-center, randomized, double-blinded, placebo parallel-controlled trial designed to assess the efficacy, safety, pharmacokinetics, and pharmacodynamic characteristics of TUL12101 in treating dry eye. The successful completion of the Phase I clinical trial, which evaluated the single and multiple administrations of TUL12101 eye drops in healthy Chinese subjects, demonstrated good safety and tolerability.
TUL12101 is a small molecule reactive aldehyde species (RASP) inhibitor with a novel anti-inflammatory mechanism. It alleviates inflammation by neutralizing harmful aldehydes released during the inflammatory response, thereby breaking the cycle of ocular surface inflammation and treating eye diseases such as dry eye syndrome. The drug is in the same class as reproxalap, another RASP inhibitor that was acquired by AbbVie in a USD 1.4 billion deal for Aldyra Therapeutics in November 2023.- Flcube.com
