Korea's bio corporations Peptron(087010) and U.S. drugmaker Eli Lilly and Company have expanded their ongoing 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, Peptron CEO, 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 has completed initial validation," adding, "We are expanding the scope from obesity and diabetes to CNS disorders and are conducting research."
However, after the forum, an interpretation spread in some corners of the market that "the already commercialized GLP-1 class agent (tirzepatide) was excluded from the joint research targets between Peptron and Lilly." Affected by this, Peptron shares fell 29.99% in after-hours trading.
But ChosunBiz reporting found that the joint research with Lilly has already completed work on a once-monthly formulation of a commercialized GLP-1 class agent, after which the research scope was expanded to next-generation candidates. This differs from the market view that a commercialized GLP-1 class agent was excluded from joint research and technical feasibility assessment.
Lilly is currently conducting large-scale clinical trials to assess whether its GLP-1 obesity drug "Mounjaro (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 applying Peptron's SmartDepot to its peptide-based candidates to verify the feasibility of developing a once-monthly formulation. SmartDepot is a technology that increases the uniformity of drug-loaded microspheres to precisely control the release rate.
The joint research, originally slated to end late last year, was extended through Oct. 7. The industry sees the extended timeline as adding technical feasibility assessment for CNS disorder treatment candidates.
According to the company, the technical feasibility assessment began by verifying the applicability of a long-acting formulation using a GLP-1 class obesity treatment that is commercialized globally. The company said the initial assessment used a globally commercialized GLP-1 class obesity treatment, and based on the data, the joint research scope was expanded to next-generation candidates with improved side effects.
In particular, the company drew a line under the market view that a commercialized GLP-1 class agent was excluded from the feasibility assessment, saying that is not true. The current research has only expanded to focus on next-generation candidates, and the applicable target could change at the definitive agreement stage.
On the possibility of a definitive agreement after the joint research ends on Oct., 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 will 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.
Earlier, the industry had projected that the groundbreaking of the second Osong plant could be delayed from the original expectation, but Choi personally denied that. The market expects that once completed, the second plant will become a key hub for producing drugs using SmartDepot.
Choi also said the company plans to enter clinical trials within the year for the long-acting obesity treatment candidate "PT403." 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 the existing once-weekly semaglutide formulation. The company said that in particular, in safety evaluations in adults, it significantly reduced gastrointestinal side effects typical of GLP-1 class treatments, 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 its next-generation platform "LUNA-PHLEX," following SmartDepot. LUNA-PHLEX is an ultra-long-acting platform that sustains peptide drugs for one to three months.
Choi said, "Peptides have excellent efficacy but are limited by a short half-life," adding, "While once-weekly formulations are mainstream now, they will evolve to once monthly and further to once every three months."
Choi added that Peptron has obtained domestic approval and is selling "Lupone," 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.