# PureTech Health Follica plans to initiate its Phase 3 programme this year

- Link: https://www.directorstalkinterviews.com/puretech-health-follica-plans-to-initiate-its-phase-3-programme-this-year/412828299
- Published: 2020-06-04T07:24:04+01:00
- Author: Giles Arbor

**PureTech Health plc** (LON:PRTC), a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercialising highly differentiated medicines for
devastating diseases, has today noted that its Founded Entity, Follica, today announced
positive feedback from an End of Phase 2 meeting with the US Food and Drug Administration(
FDA) for its lead programme to treat male androgenetic alopecia. The company plans
to advance the programme into Phase 3 development this year following the successful
safety and efficacy optimisation study announced in December 2019.

> **Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech,
> 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 3 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.”

Follica plans to launch its Phase 3 programme this year. Overall, approximately 
280 patients will be enroled, 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
centers across the US. A maximal use study to further understand the pharmacokinetics
of the treatment will be conducted in parallel. The trial design is consistent with
feedback from the FDA during the End of Phase 2 meeting.

“In the US alone, 47 million men are affected by progressive hair loss caused by
androgenetic alopecia, a condition that is largely unresolved today, leaving many
dissatisfied with the current available treatments and looking for a new alternative.
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 Follica. “We’re grateful 
to the FDA for their guidance as we prepare for our pivotal programme, and we look
forward to advancing the development of our treatment regimen, which has demonstrated
strong potential to address the current need for those who seek treatment for androgenetic
alopecia.”

Follica’s approach is based on generating an “embryonic window” in adult scalp cells
via a series of short office-based treatments with its proprietary Hair Follicle
Neogenesis (HFN) device. The scalp 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.

Follica reported topline results from its safety and optimisation study in December
2019. That trial was designed to select the optimal treatment regimen using Follica’s
proprietary HFN device in combination with a topical drug and successfully met its
primary endpoint. The selected treatment regimen demonstrated a statistically significant
44% improvement of visible (non-vellus) hair count after three months of treatment
compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall
improvement of visible (non-vellus) hair count after three months of treatment was
29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across
the entire trial population and a substantially improved outcome with the optimal
treatment regimen. Additionally, a prespecified analysis comparing the 44% change
in visible (non-vellus) hair count to a 12% historical benchmark set by approved
pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimisation study, Follica has validated its approach
in prior clinical studies using prototype HFN devices with different treatment parameters
and therapeutic compounds. Follica’s translational work builds on research by George
Cotsarelis, MD, who isolated and characterised the expression pattern of stem cells
from a critical region of the follicle. An expert in epithelial stem cell biology,
Dr Cotsarelis is chair of the department of dermatology at the University of Pennsylvania
and a co-founder of Follica.

PureTech Health is a clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for devastating diseases,
including intractable cancers, lymphatic and gastrointestinal diseases, central 
nervous system disorders and inflammatory and immunological diseases, among others.
The Company has created a broad and deep pipeline through the expertise of its experienced
research and development team and its extensive network of scientists, clinicians
and industry leaders. This pipeline, which is being advanced both internally and
through PureTech’s Founded Entities, is comprised of 23 product candidates and one
product that has been cleared by the US Food and Drug Administration (FDA). All 
of the underlying programmes and platforms that resulted in this pipeline of product
candidates were initially identified or discovered and then advanced by the PureTech
team through key validation points based on the Company’s unique insights into the
biology of the brain, immune and gut, or BIG, systems and the interface between 
those systems, referred to as the BIG Axis.

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