Lōkahi Therapeutics™ Initiates Clinical Trial Manufacturing for LT-100
One year of work focused on one goal: manufacturing clinical material to enable once-weekly dosing
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Lōkahi Therapeutics™ Inc., a subsidiary of Glucotrack, Inc. (NASDAQ: GCTK), today announced that it has started its initial Good Manufacturing Practice (GMP) manufacturing campaign for LT-100 (pure honeybee venom), the Company’s lead development candidate for osteoarthritis pain.
The advancement of LT-100 to GMP production marks the next step in the Company’s strategy to administer LT-100 (pure honeybee venom) as a single subcutaneous injection per visit – a patient-centric approach compared to the 15 intradermal injections per treatment used in prior efficacy trials.
“Earlier this year, we outlined our strategy to transition from 15 intradermal injections per administration to a single subcutaneous injection,” said Erik Emerson, CEO of Glucotrack. “Initiating GMP manufacturing marks an important step forward as we prepare to evaluate whether this patient-friendly, non-opioid treatment approach can achieve the clinical outcomes we expect in osteoarthritis of the knee.”
The ongoing GMP manufacturing campaign is expected to produce clinical trial material intended to support advancement of the program through its next clinical and regulatory milestones. Subject to successful completion of manufacturing activities, quality assurance reviews, remaining clinical preparations and regulatory review, the Company expects to enroll the first patient later this year.
LT-100 is a pure honeybee venom-derived biologic being developed as a potential treatment for osteoarthritis pain in patients with knee pain who have not responded adequately to conservative non-pharmacologic therapy and simple analgesics, or who are intolerant of NSAIDs. It was originally developed and approved for marketing in South Korea in 2003 by the Korean Food and Drug Administration (KFDA; now the Ministry of Food and Drug Safety [MFDS]).
About Lōkahi Therapeutics™
Lōkahi Therapeutics is a capital-efficient biopharmaceutical platform company focused on identifying, evaluating, acquiring, and advancing overlooked therapeutic assets. Through its ai² platform and ai² Futures Lab execution model, Lōkahi integrates cross-functional expertise and disciplined decision-making to drive strategic development and long-term value creation. For more information, please visit www.lokahithera.com. For more information about the ai² Futures Lab program, please visit www.ai2futureslab.com.
About Glucotrack, Inc.
Glucotrack, Inc. (NASDAQ: GCTK) operates Lōkahi and, through its subsidiary Glucotrack Technologies, Inc., is also focused on the design, development, and commercialization of novel technologies for people with diabetes, including a long-term implantable continuous blood glucose monitoring system. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit www.glucotrack.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate,” “believe,” “expect,” “plan,” “intend,” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to: the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations, or otherwise); the ability to successfully complete GMP manufacturing activities and quality assurance reviews; risks relating to the receipt and timing of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials, including the ability to enroll patients on the anticipated timeline; risks that LT-100 may not achieve the expected clinical outcomes;; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 30, 2026.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260825097954/en/
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