HedgePath reports positive interim data from Phase IIb trial of SUBA-Itraconazole to treat Gorlin Syndrome

3rd August 2016 (Last Updated August 3rd, 2016 18:30)

US-based, clinical stage biopharmaceutical company HedgePath (HPPI) has reported positive interim data from its Phase IIb clinical trial of SUBA-Itraconazole to treat basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin Syndrome.

US-based, clinical stage biopharmaceutical company HedgePath (HPPI) has reported positive interim data from its Phase IIb clinical trial of SUBA-Itraconazole to treat basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin Syndrome.

SUBA-Itraconazole results in a better absorption of itraconazole in order to improve the bioavailability of poorly soluble, orally administered drugs.

It allows reduced intra-patient and inter-patient variability for both the patients and prescribers while enabling predictable clinical response, and also limits drug quantity to generate required therapeutic blood levels.

The open-label, Phase IIb clinical trial involved 13 patients afflicted with BCCNS displaying basal cell carcinoma (BCC) target tumours with ten surgically eligible lesions, and had experienced surgical removal of ten BCC tumours.

The patients were administered with SUBA-Itraconazole dosing for 16 weeks.

An interim analysis of 167 individual target lesions across all 13 subjects was carried out to determine the target tumour baseline change within each patient and a change in the longest diameter of all patient target lesions.

"SUBA-Itraconazole results in a better absorption of itraconazole in order to improve the bioavailability of poorly soluble, orally administered drugs."

Results displayed no further increase of the size of the tumour, and a reduction in its size has been observed.

BCCNS causes development of multiple basal cell carcinomas requiring surgery and leading to disfigurement, particularly while treating facial tumours.

HPPI believes that a reduction or complete obliteration of the tumour can delay or eliminate the requirement of surgery, hence avoiding disfigurement.

HPPI’s dosing regimen additionally demonstrated tolerability with Grade 1 or no toxicity reported in most of the patients.


Image: Graph displaying change in target tumour. Photo: courtesy of PRNewsFoto/HedgePath Pharmaceuticals, Inc.