Starpharma hits 60% enrolment in BV trials

Starpharma Holdings (ASX:SPL) has reached 60% enrolment for trials of its VivaGel formulation as a treatment for bacterial vaginosis, less than three months after starting recruitment.

One of the two concurrent phase III trials has reached 80% enrolment, the company revealed on Monday, stating that it remains on track to completing and reporting the studies this year.

Recruitment in the trials commenced in March.

In a research note, Shaws Stockbroking biotech and healthcare analyst Matthjis Smith said the pace of enrolment in the trials “provides a good indication of the potential demand for a new treatment for BV and the number of patients who may be seeking such a product.”

He predicted that based on the recruitment rate, both trials will complete within 8-12 weeks, and that data from the trials will be available by late Q3 or early Q4.

Shaws Stockbroking has a buy recommendation for Starpharma shares, with a 12-month price target of $2.30.

Data from the trials will be used to support an investigational new drug application with the US FDA. The agency has already provided an agreement as part of a Special Protocol Assessment (SPA) declaring that the trial design and target endpoints will be acceptable for FDA approval.

The active ingredient in VivaGel is an antimicrobal agent which has been shown to inhibit the infection of STDs including HIV and herpes, as well as the growth of bacteria.

Unlike traditional antibiotic treatments for bacterial vaginosis, VivaGel is not absorbed into the bloodstream, so it is free of the side-effects associated with antibiotics.

The product has also been developed as a microbicide, and Starpharma is currently preparing to launch a line of VivaGel coated condoms, in partnership with Ansell and Okamoto.

Starpharma has forecast royalties from the condoms of over $100 million. The company estimates that the market for topical bacterial vaginosis treatments to be worth between US$300-$350 million ($310-$360 million).

Despite the encouraging news, Starpharma (ASX:SPL) shares were trading 5.5% lower at $1.37 by 4:30pm on Monday, which is steeper than the 2% drop in the All Ordinaries.