Aisa Pharma is dedicated to bringing new disease-modifying treatments to patients with rare serious diseases that are seldom the target of big pharma development programs and have few effective treatment options. The FDA defines rare diseases as being “orphan” when they affect <200,000 individuals in the United States. Aisa believes that a class of drugs called calcium channel blockers, commonly used to treat high blood pressure, can be “repurposed” to treat some of these rare diseases especially when combined with other drugs that although used to treat these illnesses, don’t have adequate treatment effects or are poorly tolerated. There are several types of calcium channels and Aisa believes that by selectively blocking certain calcium channels other than those targeted by existing drugs, that a differentiated treatment effect will be demonstrated. Aisa is initially focused on drugs that target the N-calcium channel specifically because of its role in the vasculature, heart, kidney, and nervous system.

“Re-purposing” a drug that’s approved for another indication, gives Aisa and other companies that have employed this approach, the assurance that the drug can be dosed safely, as well as information on dose. This significantly reduces the risk of development failure (by more than 50%), since most development candidates do not succeed because of side effects, and it further reduces the cost and time for approval since the prior safety database for the drug can often be leveraged in the application process. Almost a third of new drug approvals are repurposed drugs and some recent examples of approved repurposed drugs include remdesevir, sildenafil (Viagra and Revatio), minoxidil (Rogaine), azathioprine, thalidomide, and methotrexate.

Aisa is beginning its development program with a plan to repurpose cilinidipine, a widely-used calcium channel blocker approved in Asia to treat high blood pressure that has unique N-channel blocking activity, in combination with tadalafil, a drug commonly used to treat ED, for the purpose of treating Raynaud symptoms in patients with scleroderma. Aisa is starting the RECONNOITER Phase 2 study in April of 2021 to investigate the safety and efficacy of the drug combination in 76 patients with the disease.