PureTech unit Follica cues up phase 3 programme for male hair loss

PureTech has said one of the companies it has founded – Follica – is preparing to start registration trials for its drug-device therapy for treating male pattern baldness in the US after fruitful discussions with the FDA.

UK-listed PureTech said the trial in this type of hair loss – also known as male androgenetic alopecia and resulting in characteristic loss of hair at the temples and crown – will get underway later this year.

The ‘microneedling’ Hair Follicle Neogenesis (HFN) device is designed to disrupt the skin of the scalp and stimulate growth factors and stem cells that can create new hair follicles.

Use of the device takes a few minutes in the doctor’s office, and is followed by a topical therapy with a drug. That could include minoxidil or finasteride – which are already well established as treatments for hair loss but are known to have limited efficacy.

Last December, the company reported the results of a 48-patient phase 2 trial of the drug-device combination which was intended to work out the best treatment regimen.

Across three different regimens, the overall improvement in visible or ‘non-vellus’ hair counts after three months was 29%, with the best-performing approach – used in 19 patients – achieving a 44% increase.

Follica says the phase 3 trials will enrol around 280 patients at sites in the US and will gauge the effectiveness of treatment based on non-vellus hair counts and patient-reported outcome data. At the same time, it plans to start a maximal use study “to further understand the pharmacokinetics of the treatment.”

Existing drugs like minoxidil and finasteride can thicken and maintain remaining hair, but are not so effective at stimulating new hair growth.

Restoring follicles to bald areas can only be effectively achieved at the moment with hair transplants, but these require a surgical procedure that can keep people off work for days and can sometimes lead to complications like bleeding and infections. Surgeons tend to also use topical drugs to thicken transplanted hair.

“Our recent safety and optimisation study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair,” said Jason Bhardwaj, chief executive officer of Boston-based Follica.

The company notes that there are around 47m men in the US with some degree of pattern baldness, which is driven by hormonal changes and tends to be progressive.

Other companies sell microneedling devices for the purpose of hair loss, but Follica’s HFN reportedly differs in a number of aspects, including the number and gauge of microneedles and the frequency and density of needle pricks.

It is also thought to be the only company that has FDA approval to start a phase 3 trial of such a device.