Development Pipeline

Aisa has completed a Phase 2a-2 Study of AISA-021 (cilnidipine) in patients with Secondary Raynaud’s, primarily due to Scleroderma in Australia (RECONNOITER-1) study. This was a two-part study, with the first part dose-finding and parallel design and the second part a double-blind randomized crossover design where each patient was dosed with either placebo or active treatment separated by a washout period. A total of 66 patients were recruited in both parts of the study.

Aisa is considering other development programs and is evaluating the biologic actions of AISA-021 in preclinical studies. These activities are ongoing and the NIH is studying Aisa’s AISA-021 as well in its Preclinical Screening for Pain Platform studies. To date, this program has demonstrated the drug to have no potential for abuse or addiction and predictable and reproducible pharmacokinetics. The following diagram illustrates Aisa’s development pipeline: