When Mihael Polymeropoulos founded Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) in 2003, he did not know that it would turn out to be a biomedical enterprise. He aimed to improve the lives of patients through the delivery of novel medicines. The CEO did not struggle to accomplish this mission, thanks to a partnership with Care Capital LLC, a prominent biopharmaceutical, and Bio*One Capital, a Singapore government’s investment arm.
Vanda has been working on a development program for tradipitant; a potential treatment candidate for both diabetic and idiopathic gastroparesis. The tradipitant is in a Phase III study with 30% enrollment of the anticipated 200 randomized patients from the current report. The enrollment is expected to be completed in the first half of 2021.
Advanced Update on the Development of Tradipitant in Gastroparesis
Currently, a tradipitant is approved for use by the FDA for only Six months. However, individual patients have an option of renewal, but they must ask for expanded access. The FDA has received hundreds of applications from patients who have already experienced unique benefits and are seeking expanded access.
This explains that the new gastroparesis therapy is likely to gain a significant commercial opportunity if approved and would benefit more than 6 million gastroparesis victims. Vanda also says that the article “Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis has been placed for publication.
Results from Previous Phase II Study Showed Significant Improvement
The previous Vanda’s Phase II double-blind trial enrolled 152 adults across 47 sites in the US. All of them had a symptom of gastroparesis. For four weeks, 85 mg of tradipitant was administered twice daily, and the result was incredible. At week four, there was a notable improvement in nausea, which is the gastroparesis’s primary symptom. This resulted in increased nausea-free days.
It is worth mentioning that Vanda’s success has been consistent. This is because the company has never lost sight of its ultimate goal; improving patient’s lives. Hence, it has maintained its standards throughout its product development processes. This is in addition to holding onto scientific collaborations with other industry players.