Accentia preparing to begin phase 3 clinical trials of SinuNase

By Jennifer Lanning Drey

Eugene, Ore., June 28 - Accentia Biopharmaceuticals, Inc. is preparing to begin phase 3 clinical trials this summer of SinuNase, the company's intranasal Amphotericin B formulation for chronic sinusitis, said Frank E. O'Donnell Jr., chairman and chief executive officer of the company, speaking at the Jefferies Life Sciences Conference on Wednesday.

The drug was granted fast track status by the Food and Drug Administration in April, and Accentia expects to receive approval for SinuNase in 2008 and launch the product later that year.

"These are not large clinical trials, so I don't think it will be difficult to submit the [New Drug Application]," said O'Donnell.

The first phase 3 clinical trial of SinuNase will be a randomized, double-blind, placebo-controlled trial involving 300 patients with a prior history of sinus surgery. The primary endpoints for the trial will be patient-reported outcomes, and in particular, improvement in cardinal symptoms, O'Donnell said.

The company expects to report results from the trial in February.

Accentia is also planning to start a second phase 3 clinical trial later in the summer or in early fall that will involve 450 patients who have not had sinus surgery. The company expects to report those results in May.

Accentia said there is no other approved pharmaceutical or pipeline product that it views as direct competing with SinuNase.

"For chronic sinusitis, there are 31 million affected patients and no approved product. That's really the essence of the economic opportunity," O'Donnell said.

Accentia believes the initial market for the drug's initial target will be between 4 million and 12 million people, he said.

SinuNase was developed based on research performed by the Mayo Clinic that demonstrated airborne fungi play a significant role in chronic sinusitis. It also showed that the condition can be substantially relieved by treating patients with a low-dose intranasal application of antifungals, such as Amphotericin B, which is already approved for other indications.

"We're using an approved drug with a large, untapped market opportunity," said O'Donnell.

In addition, the drug does not need to be absorbed into the tissue to be affective, which gives it an attractive safety profile, he said.

Accentia acquired a license from the Mayo Foundation for Medical Education and Research that allows it to develop SinuNase as a self-administered therapy to relieve symptoms associated with chronic sinusitis.

Accentia also has exclusive rights to a complementary diagnostic developed by the Mayo Clinic, O'Donnell said.

With fast track status, Accentia is eligible to submit its New Drug Application on a rolling basis, allowing the FDA to review sections of the application in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its application.

Accentia is a Tampa, Fla., biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

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