HedgePath hogs time to chat with FDA
- Following positive Phase 2b interim data, HedgePath Pharmaceuticals has announced a formal Type C guidance meeting with the Food and Drug Administration to discuss its ongoing study of SUBA-itraconazole.
- In the third interim analysis of the open label study involving 35 patients with basal cell carcinoma nevus syndrome and with a history of basal cell carcinoma surgery, 97% of those dosed with the improved bioavailability formulation of the antifungal itraconazole were able to avoid surgery, all saw some reduction in tumors, and 37% saw a 30% or greater reduction in target tumor burden. Across all patients, 28% of target lesions disappeared. The dropout rate was 11%.
- The next step is to file a complete background package for the Phase 2b trial results with the FDA by mid-June 2017, and the company expects a response with further guidance by the end of July. HedgePath, which has a market cap of only $122.0 million, has seen a 6% jump in its stock price on the announcement.
Named after its focus on the Hedgehog signaling pathway, HedgePath Pharmaceuticals is repurposing the off-patent antifungal itraconazole as a potential anticancer drug. A patented reformulation with improved bioavailability, SUBA-itraconazole (SUBA-Cap) is in a Phase 2b clinical trial in patients with basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin syndrome. This is a chronic genetic condition where patients develop basal cell tumors all over their body, including on the face. It affects around 10,000 people in the U.S.
"We are testing SUBA-Cap therapy in BCCNS patients with a significant history of BCC surgeries and intend to further note in our background package that, for the 35 patients being dosed in our trial, the mean number of prior of basal cell carcinomas removed by surgery was 195 per patient, yet 97% of our study group have avoided surgery while on SUBA-Cap therapy," said Nicholas Virca, president and CEO of HedgePath.
Drug developers can have three different types of formal meetings with the FDA – type A, type B and type C. Type A are the meetings to help resolve stalled drug development, for example a clinical hold. Type B meetings include pre-Investigational New Drug (IND) application meetings, end of Phase 1 or 3 meetings, pre-Phase 3 meetings and pre-New Drug Application (NDA) or Biologics License Application (BLA) meetings. Type C meetings are any other meetings between drug developers and FDA staff regarding a drug's development or review.
- HedgePath Pharmaceuticals Statement
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