Shrewsbury, MA, March 26, 2026 – SignaBlok, Inc., a preclinical stage biotechnology company pioneering novel, first-in-class peptide therapies for multiple inflammation-associated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s TREM-1 peptide inhibitor for the treatment of retinopathy of prematurity (ROP).
“Orphan Drug
Designation for ROP represents a significant milestone in the development of our
TREM-1 therapy for the treatment of ROP” said Alexander B. Sigalov, Ph.D.,
President and Founder of SignaBlok. “This decision by the FDA recognizes the
potential for a first-in-class, macrophage-targeted TREM-1 peptide inhibitor to
address a high unmet need for preterm infants suffering from ROP. We are very
encouraged by favorable preclinical efficacy, pharmacokinetic and tolerability data
in clinically relevant animal models. These data will be presented at the 2026
annual meeting of the Association for Research in Vision and Ophthalmology
(ARVO) to be held in Denver, Colorado, May 3-7, 2026".
The FDA's Orphan Drug
Designation program provides orphan status to drugs defined as those intended
for the safe and effective treatment, diagnosis or prevention of rare diseases
that affect fewer than 200,000 people in the United States. Orphan Drug
Designation qualifies the sponsor of the drug for certain development
incentives, including tax credits for qualified clinical testing, prescription
drug user fee exemptions and seven-year marketing exclusivity upon FDA
approval. About retinopathy of
prematurity (ROP)
ROP affects 50-70% of
preterm infants weighing less than 1,500 grams at birth, in several cases
leading to blindness. Approximately 400 to 600 infants in the United
States become legally blind annually due to ROP. Current treatments do not
sufficiently address the medical need with severe cases, necessitating the
development of new approaches. About TREM-1 Triggering receptor expressed
on myeloid cells 1 (TREM-1) serves as an inflammation amplifier. As such, TREM-1
is critically involved in the pathogenesis of inflammatory diseases, including
ROP. Clinical targeting of TREM-1 is challenging due to multiple and unknown TREM-1
ligands. SignaBlok's TREM-1 inhibitor addresses this challenge by a new,
ligand-independent mechanism of action. About SignaBlok SignaBlok, Inc. is a
Massachusetts-based biotechnology company founded in 2009 to develop
innovative, first-in-class therapeutics for targeted treatment of
inflammation-associated diseases through the use of two key SignaBlok's proprietary
technologies: 1) new mechanism-based approach to inhibition of cell receptors
by using innovative, ligand-independent inhibitory peptides (the so-called
SCHOOL peptides, the abbreviation coming from the "Signaling Chain
HOmoOLigomerization" model of immune signaling); and 2) nature-inspired,
multifunctional nanotechnology for targeted drug and/or imaging agent delivery
to macrophages. Additional information about SignaBlok is available at www.signablok.com.
SignaBlok’s Contact: Alexander
Sigalov, Ph.D., President and Founder: (203) 505-3807; sigalov@signablok.com
