Nuvectis Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for NXP800 to treat cholangiocarcinoma.

NXP800, a small molecule taken orally, is currently being assessed in a Phase Ib clinical trial.

The study is designed to explore the drug candidate’s clinical activity as a potential treatment for platinum-resistant, ARID1a-mutated ovarian carcinoma.

Nuvectis has already received fast track designation for the NXP800 development programme.

It is also developing another drug candidate, NXP900, a new small molecule inhibitor targeting the SRC/YES1 kinases.

The FDA has cleared the IND for NXP900 and a Phase Ia dose escalation trial is yet to commence.

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Nuvectis chairman and CEO Ron Bentsur stated: “NXP800 is an oral small molecule with a novel mechanism of action that has demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as cholangiocarcinoma.

“This orphan drug designation is an important milestone in our journey toward our mission of developing NXP800 for the treatment of serious conditions of unmet medical need in oncology.”

Cholangiocarcinoma is a biliary tract cancer, which emerges in the biliary tree epithelium.

With an annual incidence of nearly 8,000 to 10,000 in the US, it accounts for around 3% of all gastrointestinal malignancies.