OPKO Health’s OPKO Biologics Doses First Participant in Phase 1/2a Trial of OPK-8801001 for Acromegaly
Key Highlights
- ➤OPK-8801001 enters first-in-human Phase 1/2a trial for acromegaly
- ➤Trial will assess safety, tolerability, pharmacokinetics and pharmacodynamic activity
- ➤OPK-8801001 targets once-weekly dosing through stabilizer-based technology
- ➤Preclinical studies showed sustained, dose-dependent IGF-1 suppression
- ➤Preclinical testing found approximately 20-fold greater receptor antagonism versus pegvisomant
Expert Statements
Laura Moschcovich, Ph.D., General Manager of OPKO Biologics
“Dosing the first participant marks an important milestone for OPK-8801001 and for OPKO Biologics’ commitment to advancing differentiated therapies for patients with serious endocrine disorders.”
Laura Moschcovich, Ph.D., General Manager of OPKO Biologics
“OPK-8801001 was designed to combine a potent growth hormone receptor antagonist with a long acting stabilizer intended to support less frequent administration.”
Laura Moschcovich, Ph.D., General Manager of OPKO Biologics
“We look forward to evaluating its clinical performance and its potential to improve disease control while reducing treatment burden for people living with acromegaly.”
Phillip Frost, M.D., Chairman and CEO of OPKO Health
“The initiation of this first in human study reflects OPKO’s strategy of applying innovative technologies to well-established biological pathways to satisfy persistent meaningful patient needs.”
Phillip Frost, M.D., Chairman and CEO of OPKO Health
“We are pleased to support OPKO Biologics as it advances OPK-8801001 into clinical development and as it continues to build a differentiated endocrinology based pipeline.”
KIRYAT GAT, Israel, Oct. 27, 2026 (GLOBE NEWSWIRE) -- OPKO Biologics Ltd., an OPKO Health company (NASDAQ: OPK), today announced that the first participant has been dosed in a first-in-human Phase 1/2a clinical trial of OPK-8801001, an investigational, long acting human growth hormone receptor antagonist being developed for the treatment of acromegaly. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of OPK-8801001.
OPK-8801001 is being developed using OPKO Biologics’ stabilizer based technology to extend serum half life and reduce injection frequency, with the goal of once weekly administration. In preclinical studies, OPK-8801001 produced robust, dose dependent sustained suppression of insulin-like growth factor-1 (IGF-1), a key marker of disease activity in acromegaly. In vitro studies also demonstrated potent growth hormone receptor antagonism.
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