Trefoil
Therapeutics Announces the Signing of a License and Research Agreement with
Florida State University for Engineered FGF-1 Derivatives
Development
Program to Focus on the Treatment of Corneal Dystrophies
Trefoil Therapeutics
today announced the signing of a license and research agreement with Florida
State University for the development of engineered FGF-1 derivatives (eFGF-1s).
This agreement gives Trefoil an exclusive license to the eFGF-1 patent estate
for therapeutic and cosmetic uses. This
collaboration will advance the existing eFGF-1 technology developed by Dr. Michael
Blaber, Professor at FSU and a co-founder of Trefoil.
The eFGF-1 platform
represents an innovative approach to the improvement of pharmacokinetic
properties of fibroblast growth factors as drugs, yielding novel FGF-1s. These eFGF-1s have demonstrated superior pharmacodynamic and pharmaceutical properties compared to
the naturally occurring FGF-1s in animal models of tissue healing. A lead compound for development for corneal regeneration
has been selected (TTHX-1014) and Trefoil is moving this compound towards an
IND application. Corneal regeneration
has been shown in in vitro rabbit models.
Brent Edington, Head of
the Office of Commercialization at FSU, noted that “This collaboration
for the development of novel therapeutics demonstrates the strength of FSU’s
research programs and the focus of scientists at FSU on research relevant to
human benefit”.
“Trefoil is delighted to
be able to partner with the powerful research capabilities of FSU and the
Blaber laboratory for the further development of the eFGF-1 technology” said Dr.
David Eveleth, CEO of Trefoil.
The first therapeutic
application focuses on eliminating the most common driver of corneal
transplantation, Fuchs corneal dystrophy (CED). CED can lead to severe visual loss for which there
is currently no approved pharmaceutical therapy.
“Corneal dystrophies are a category of serious, sight
threatening conditions that have limited treatment options today; aside from
surgical intervention” said William Trattler, MD, Director of the Center for Excellence in Eye Care,
Miami, FL. “There is a
significant need for therapeutic agents that can treat or slow the progression
of this category of diseases and this innovative new class of drug may
significantly expand our treatment options.”
The broad family of
patents covering eFGF-1s was also bolstered recently by the issuance of US
patent 8,962,557, which describes additional fibroblast growth factor mutants with
improved functional half-life and use methods. Further, over the last 12 months, several other
patents have been filed covering new aspects of eFGF-1 technology and
strengthening the intellectual property protection for these novel
therapeutics.
Trefoil also announced
the addition of two new members of its team. Schalon Newton, D.M.
has been appointed Chief Business Officer and will be responsible for business
development, partnering and strategy. Schalon was the head of business development at Santen and
spent more than 20 years at Allergan, including leading Allergan’s Japanese
subsidiary.
William Stewart, M.D.,
will serve as a development consultant to Trefoil, leading the development of
the clinical strategy and the initial clinical trial. Dr. Stewart is an ophthalmologist and founder
of PRN, a leading clinical ophthalmic contract research organization, and PharmaFarm which assists startups with unique innovative
technology, such as Trefoil, with their development process.
About Trefoil:
Trefoil’s
mission is to improve human health and create new therapies using drugs
developed with protein engineering. Trefoil
hopes to bring this novel therapy into clinical testing within 18 months. Other potential applications for the eFGFs include regenerative therapies that may address a
broad range of ischemic disease, including coronary heart disease, diabetic
ulcers, and peripheral artery disease.
Trefoil
has received several accolades including winning the CONNECT Springboard
business plan program (2013) and the Southeast Biotechnology Early Company
Competition (2014).
Forward-Looking Statements
The preclinical
research discussed in this press release is preliminary and the outcome of such
preclinical studies may not be predictive of the outcome of later clinical
trials. Future clinical trial results
may not demonstrate safety and efficacy sufficient to obtain regulatory
approval related to the preclinical research findings discussed in this press
release.
For information contact:
Dr.
David Eveleth, CEO
917
628 8502