Starpharma emphasises portfolio after VivaGel trial fail

Surprise and disappointment set the tone at the Starpharma (ASX:SPL) annual general meeting, held yesterday, following the announcement on Wednesday that a phase III trial of VivaGel for treating bacterial vaginosis (BV) failed to reach its primary end point.

Chairman, Peter Bartels, addressed shareholders stating he was hoping to deliver a far more upbeat speech.

“As I stand here I can understand, and I share, your disappointment and surprise that our phase III trial for the treatment of bacterial vaginosis has not met the end point required to obtain FDA approval,” he said.

However, he also put a positive spin on the bad news by emphasising the breadth of Starpharma’s technology platform.

“It is a stark reminder of the challenges drug developers face but it also allows me to remind investors why they have placed their faith in Starpharma.

“The fundamentals of this company remain – we have a platform technology that has allowed us to support a diverse and robust portfolio of products at different stages on the development curve and across multiple industries.

“We have attracted some of the world’s leading companies as partners and in the last year we have undertaken deals with AstraZeneca and NuFarm and extended our relationship with Lilly.”

The company’s stock took a pounding following the release of the trial results on Wednesday, dropping from around $1.63 to $1.00 almost immediately in heavy trading, climbing back to $1.16 by day’s end on Thursday.

The results of the phase III trial showed that VivaGel demonstrated statistically significant effectiveness in days following initial treatment, but the primary end point of a clinical cure versus placebo two to three weeks later was not met.

As a result, a New Drug Application will not be filed for VivaGel as a cure for BV.

The company is investigating some unexpected results as a part of the trial, such as high placebo cure rates at some sites and the fact that placebo cure rates increased between time points in the trial rather than decreased as expected.

However, given the trial outcomes of dramatically reducing symptoms and curing BV in some of the patients, Starpharma is continuing to pursue VivaGel as a potential prevention of BV recurrence.

Phase II trials are already underway into this indication, and according to the company, these phase III results won’t hamper the application for recurrence.

The failure to meet the expected end point is a blow to Starpharma, which has otherwise had a strong year.

“We are surprised and disappointed in not meeting the phase III FDA endpoint for the treatment indication in these trials, given the phase II trial results,” said CEO Dr Jackie Fairley.

“However, we are also greatly encouraged by the statistically significant efficacy and excellent symptomatic relief shown for VivaGel at the end of treatment in these studies and we do plan to fully explore the potential for regulatory filings based on these data.

“In addition we, and our expert clinical advisors, see the efficacy demonstrated with VivaGel, the excellent safety profile and patient feedback as very positive for the prevention indication.”

At the AGM, Bartels emphasised that Starpharma’s platform technology has manifold applications, and an injection of funds late last year has enabled the company to advance opportunities in drug delivery and agrochemicals.

The company finished the financial year with $37.6 million in cash, recently buoyed by $6m from the R&D Tax Incentive.

Founding director of Starpharma, Ross Dobinson, also tendered his immediate resignation and didn't stand for re-election, even though he was slated to do so up until earlier this week.

Starpharma is still down from its pre-trial levels and is trading at $1.13 as of around 11.30am Friday.