Business
Follica Positive Interim Data & Plans for Pivotal
Follica Positive Interim Data & Plans for Pivotal.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \nRNS Number : 0368C PureTech Health PLC 13 June 2019 \n\n13 June 2019\nPureTech Health plc\n \nFollica Announces Positive Interim Data and Progression to Pivotal Study in Male Androgenetic Alopecia\n \nPivotal study expected to begin in late 2019\n \nPureTech Health has increased its ownership in Follica to 77%\n \nPureTech Health plc (LSE: PRTC) (\"PureTech Health\"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to note that its affiliate, Follica, announced today that it will progress the program to a pivotal study following positive interim data from an ongoing safety and optimisation study in male androgenetic alopecia (male pattern hair loss). In addition to demonstrating tolerability and informing key treatment parameters, the study achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment, compared to baseline, according to an analysis of 20 study participants. Additionally, blinded head-to-head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. A pivotal study is expected to initiate at the end of 2019 subject to continued safety and efficacy in the optimisation study. PureTech Health has increased its ownership in Follica and now holds a 77%i equity stake in the company, in addition to royalties from potential sales.\n \nDaphne Zohar, founder and chief executive officer of PureTech Health, said: \"Follica is an affiliate that we haven't spoken about as much pending these results, so we are excited to share this positive development as the company prepares to initiate its pivotal study toward the end of this year. The interim analysis showed a robust response to Follica's proprietary treatment and we believe the company is uniquely positioned to potentially address a tremendous need in a large market.\" \n \nFollica's platform is designed to induce an \"embryonic window\" in adult skin via a proprietary form of micro-abrasion that initiates hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process of hair follicle neogenesis is enhanced through the application ...