Korea-based bio corporations Peptron(087010) and U.S. drugmaker Eli Lilly and Company have expanded their joint research on a once-monthly formulation of a glucagon-like peptide (GLP)-1 agent beyond obesity to central nervous system (CNS) disorders, including Alzheimer's disease, Parkinson's disease, and alcohol use disorder (AUD).
Choi Ho-il, CEO of Peptron, said at the Shinhan Investment Corp. bio forum in Daejeon on the 9th, "Our long-acting platform 'SmartDepot' is a technology that can fully leverage the strengths of Lilly's GLP-1 agent, and we have completed the initial validation," adding, "We are expanding into CNS disorders beyond obesity and diabetes and are conducting research."
However, after the forum, some in the market spread the interpretation that "the previously commercialized GLP-1 class agent (tirzepatide) was excluded from the joint research by Peptron and Lilly." Affected by that, Peptron's share price fell 29.99% in after-hours trading.
But reporting by ChosunBiz confirmed that the joint research with Lilly expanded its scope to next-generation candidates after a technical feasibility assessment using a commercialized GLP-1 class agent. This differs from some market interpretations that the previously commercialized GLP-1 class agent, namely tirzepatide, was excluded from the joint research.
Lilly is currently conducting large-scale clinical trials to assess whether the GLP-1 obesity drug "Mounjaro (active ingredient tirzepatide)" could treat Alzheimer's disease and alcohol use disorder (AUD). The next-generation candidate "Brenipatide," which targets GLP-1 and gastric inhibitory polypeptide (GIP) simultaneously, is also in two global phase 3 trials in patients with alcohol use disorder.
Peptron has continued joint research after signing a technical feasibility assessment agreement with Lilly in Oct. 2024. Lilly is testing the feasibility of developing a once-monthly formulation by applying Peptron's SmartDepot to its peptide-based candidates. SmartDepot is a technology that increases the uniformity of drug-containing microparticles to precisely control release speed.
The joint research, initially slated to end late last year, has been extended until Oct. 7. The industry believes CNS-related candidates were added during the extension process.
According to the company, the technical feasibility assessment began with verifying the applicability of a long-acting formulation using a GLP-1 class obesity drug that is commercialized worldwide. The company said the initial assessment was conducted using a GLP-1 class obesity drug commercialized worldwide, and that, based on the data obtained, the joint research scope was expanded to next-generation candidates with improved side effects.
In particular, the company drew a line under market interpretations that a commercialized GLP-1 class agent was excluded from the joint research, saying that is not true. While the assessment target has shifted to focus on next-generation candidates, the applicable target could change at the commercialization stage.
Regarding the possibility of a main contract after the joint research ends in Oct., CEO Choi said, "We have produced and sent all the necessary data, and now only their decision remains."
Choi also said the second Osong plant in North Chungcheong Province is slated to break ground in Sept. The plan is to build a large-scale long-acting drug manufacturing facility that meets U.S. current good manufacturing practice (cGMP) standards.
Previously, the industry projected that ground-breaking for the second Osong plant could be delayed beyond initial expectations, but Choi directly denied that. The market expects the second plant, once completed, to become a key hub for producing drugs using SmartDepot.
Choi also said the long-acting obesity treatment candidate "PT403" will enter clinical trials within the year. PT403 applies SmartDepot to "semaglutide," the GLP-1 obesity drug from Denmark's Novo Nordisk, extending the dosing interval from once weekly to once monthly.
According to preclinical data released at the American Diabetes Association (ADA) last month, PT403 showed superior weight-loss effects in an obese mouse model compared with once-weekly semaglutide formulations. The company said that, in particular, safety evaluations in adults showed a significant reduction in gastrointestinal side effects typical of GLP-1 class therapies, such as vomiting and nausea.
PT403 has filed for patents in about 20 countries and aims for marketing authorization in 2030.
Alongside this, Peptron also unveiled for the first time the next-generation platform "LUNA-PHLEX," following SmartDepot. LUNA-PHLEX is an ultra-long-acting platform that maintains peptide drugs for one to three months.
Choi said, "Peptides have excellent efficacy, but they are limited by short half-lives," adding, "While once-weekly formulations are mainstream now, they will evolve into once-monthly, and further into once every three months."
Choi added that Peptron has obtained domestic approval and is selling "Leuproone," a prostate cancer and precocious puberty treatment using SmartDepot, and that it is also conducting joint research with global drugmakers on sustained-release (SR) formulation technology.