StockMarketWire.com - Biotherapeutics company PureTech Health has said that Follica, which it founded, has received positive feedback from the US Food and Drug Administration (FDA) as it prepares to advance its lead programme in male androgenetic alopecia into phase three development this year.

President and chief of business and strategy Bharatt Chowrira said: 'This positive feedback from FDA enables Follica to move forward with its pivotal trial this year.

'Current treatments for the progressive hair loss caused by androgenetic alopecia are inadequate, and we are pleased with Follica's progress towards phase three development, bringing us another step closer to a potential new treatment for the millions of people seeking safe, effective, non-surgical treatments to grow new hair.'

PureTech said that overall, approximately 280 patients will be enrolled into its phase three programme, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale.

The randomised, controlled, double-blinded studies will be conducted in multiple centres across the US, PureTech confirmed.

A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel, with the trial design consistent with feedback from the FDA during the end of phase two meeting.

Follica reported topline results from its safety and optimisation study in December 2019.

PureTech said that Follica's approach is based on generating an 'embryonic window' in adult scalp cells via a series of short office-based treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles.

A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.


At 8:06am: [LON:PRTC] Puretech Health PLC share price was 0p at 255p



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