Tides Weekly Recap | Global Peptide and Oligonucleotide Therapeutics News (Oct 10–16)
Johnson & Johnson
Medical Device R&D and Manufacturer
Protagonist Therapeutics
Developer of Novel Therapies
Recently, Rein Therapeutics (referred to as "Rein," NASDAQ: RNTX), a biopharmaceutical company, announced that it has received authorization from the European Medicines Agency (EMA) to initiate its Phase 2 "RENEW" clinical trial for its lead candidate drug LTI-03, intended for the treatment of idiopathic pulmonary fibrosis (IPF).
This authorization covers clinical trial centers in Germany and Poland, which will become the fullKey European site for ball research. Previously, Rein has obtained regulatory approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RENEW is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of LTI-03 in patients with IPF.
The study plans to enroll up to 120 patients globally, with two dosage groups, and the treatment duration will be 24 weeks.
Key secondary endpoints include changes in lung function (forced vital capacity, FVC) and assessment of fibrosis progression based on imaging.
LTI-03 is a product derived from smallPeptide drugs targeting Caveolin-1 have a dual-action design mechanism: they can inhibit fibrosis while supporting the regeneration of healthy lung tissue by protecting alveolar progenitor cells critical for lung repair.
About Rein Therapeutics
Rein Therapeutics is a clinical-stage biopharmaceutical company focused on developing "first-in-class" innovative therapies to address significant unmet medical needs in rare pulmonary diseases and fibrotic indications.
RecentlyAccording to foreign media reports, Johnson & Johnson is in talks to acquire its immunotherapy partner Protagonist Therapeutics (NASDAQ:PTGX) for an estimated amount exceeding 28.5 billion RMB (approximately 4 billion USD). The core asset behind this acquisition is icotrokinra, an oral cyclic peptide IL-23 inhibitor poised to transform the treatment landscape for psoriasis.
The two companies are currently collaborating to develop icotrokinra, an oral cyclic peptide IL-23 inhibitor for the treatment of immune diseases such as plaque psoriasis and ulcerative colitis. Johnson & Johnson holds exclusive commercialization rights to the product. Johnson & Johnson's key immunology drug, Stelara, recently lost its patent exclusivity in the U.S., and the company submitted a new drug application to the FDA in July, seeking approval for icotrokinra for the treatment of plaque psoriasis.This transaction will help Johnson & Johnson strengthen its product line as its key immunotherapy drug, Stelara, faces competition from lower-priced generic drugs.
The drug succeeded in two Phase 3 trials for plaque psoriasis at the end of last year. Johnson & Johnson CEO Joaquin Duato said at an investor conference in September 2024 that the approval of this program would have a significant impact on the market.
Johnson & Johnson andProtagonist is also seeking to expand its reach to several other immune and inflammatory diseases. Earlier this year, they announced the success of icotrokinra in a Phase 2b trial for ulcerative colitis. Additionally, Protagonist Therapeutics Inc. revealed on Thursday that a Phase 3 study for UC and a Phase 2/3 study for Crohn's disease have been initiated.
Icotrokinra is a targeted oral peptide that can selectively block the IL-23 receptor (IL-23R). IL-23 plays a key role in the pathogenic T-cell activation associated with moderate to severe plaque psoriasis and is fundamental to inflammatory responses in psoriasis, other dermatological conditions, rheumatological diseases, and IL-23-mediated gastrointestinal disorders. Icotrokinra binds with high affinity to IL-23R and exerts potent selective inhibition of IL-23 signaling in human T cells.
2025October13DayAscletis Pharma Inc. (HKEX: 1672, "Ascletis") announced the selection of ASC35, a potentially best-in-class once-monthly subcutaneous injectable GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual agonist peptide, as a clinical development candidate. Ascletis anticipates submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC35 in the treatment of obesity in the second quarter of 2026.
ASC35 is a GLP-1R and GIPR dual-target agonist peptide independently developed by Ascletis using its Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. In vitro experiments show that ASC35’s agonistic activity on GLP-1R and GIPR is approximately four times stronger than that of tirzepatide. Compared with the once-weekly administration of tirzepatide, the optimized design of ASC35 achieves a longer apparent half-life (calculated as the time required for the blood concentration to drop to 50% of Cmax) and higher bioavailability per milligram of peptide, thereby supporting once-monthly subcutaneous administration with an injection volume not exceeding...More than 1 milliliter. These optimized design features provide scalability advantages in manufacturing, resulting in lower costs in large-scale production.
About ASC35
ASC35 is being developed as a monotherapy and in combination therapies for the treatment of cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). Ascletis plans to combine the GLP-1R/GIPR dual agonist ASC35 with the once-monthly subcutaneously administered amylin receptor agonist peptide ASC36 for the treatment of obesity and diabetes. Ascletis also plans to combine ASC35 with a once-monthlyThe subcutaneous fat-targeting thyroid receptor β (THRβ) agonist ASC47 is used in combination to treat various metabolic diseases, including obesity and metabolic dysfunction-associated steatohepatitis.
AboutAscletis Pharma
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of best-in-class and first-in-class drugs for the treatment of metabolic diseases.
2025October13DayShijiazhuang Pharmaceutical Group (1093.HK) announced that the new drug marketing application for Exendin-4 Alpha Injection (hereinafter referred to as "the product"), developed by its subsidiary Shijiazhuang Pharmaceutical Group Baik Biological Pharmaceutical Co., Ltd. (Shandong), has been accepted by the National Medical Products Administration of the People's Republic of China. The product is filed as a Class 1 new therapeutic biologic, and its indication is for use in conjunction with dietary control and...On the basis of increased exercise, it is used for long-term weight management in overweight or obese adults.
This product is a recombinant human glucagon-like peptide.-1(hGLP-1)FcFusion Protein Injection, patients need to use once a week.Times. This product can selectively bind and activateGLP-1Receptor, by inhibiting appetite, reducing food intake and other mechanisms to achieveThe effect of reducing body weight, achieving glucose concentration-dependent reduction in blood sugar, and improving cardiovascular and metabolic indicators.Mark.
The new drug marketing application is primarily based on a pivotal Phase III clinical trial, which enrolled obese or overweight adult patients with at least one weight-related comorbidity. The clinical trial results showed that, compared with placebo, the product significantly reduced body weight and also significantly decreased waist circumference, blood glucose, blood pressure, blood lipids, and other indicators in patients, providing comprehensive cardiovascular and metabolic benefits. Meanwhile, the product demonstrated good safety and tolerability. Compared with similar marketed drugs, the incidence of gastrointestinal adverse events, as well as the rates of treatment discontinuation or termination due to adverse events, were lower for this product. Additionally, its dose escalation regimen was faster and simpler, requiring only 4 weeks to reach the target maintenance dose.
Currently, two projects of this product are being carried out in patients with type 2 diabetes.Phase III clinical trials are actively progressing, with the aim of benefiting more patients.
2025October14DayKailera Therapeutics (Hengrui Newco) announced the completion of a $600 million Series B financing round, led by new investor Bain Capital.Led by al Private Equity, the financing round received support from both new and existing investors. The proceeds will be used to support the continued development of Kailera's obesity treatment portfolio, including advancing the global Phase III clinical trial of its lead candidate drug, KAI-9531.
The completion of Series B financing not only provided Kailera with sufficient financial support but also injected strong momentum into its research and development in the field of obesity treatment. This funding will accelerate Kailera's progress in the development of innovative drugs, bringing new treatment options to obese patients worldwide.
Kailera Focuses on Obesity and Related Metabolic Disease Treatment, Further Solidifying Its Leading Position in the Next-Generation Weight Loss Drug Field with This Financing Round. Previously, the company completed a $400 million Series A financing in October 2024, bringing the total financing to $1 billion, with investors including well-known institutions such as Atlas Venture and Bain Capital Life Sciences.
KAI-9531 is an injectable GLP-1/GIP dual receptor agonist designed to improve obesity and type 2 diabetes by regulating appetite and metabolism. After holding an end-of-phase 2 meeting with the FDA, Kailera plans to initiate its global phase 3 program before the end of this year. The program will include two trials targeting obese or overweight adults with or without type 2 diabetes, as well as an additional trial for adults with a BMI of 35 or higher.
2025October15Day，Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 clinical trials. ACHIEVE-2 is the second head-to-head study in this series, evaluating the efficacy of orforglipron compared to the SGLT-2 inhibitor dapagliflozin in adults with type 2 diabetes whose blood sugar levels were inadequately controlled on metformin. ACHIEVE-5 evaluated the efficacy of orforglipron versus placebo in adults with type 2 diabetes whose blood sugar levels were inadequately controlled on titrated insulin glargine (with or without metformin and/or an SGLT-2 inhibitor). In both studies, at week 40, orforglipron (3mg, 12mg, 36mg) achievedAchieved primary and all key secondary endpoints, significantly reduced A1C, and achieved weight loss and improvements in multiple cardiovascular risk factors. The results were consistent with previously published studies related to type 2 diabetes.
ACHIEVE-2 and ACHIEVE-5 Study Results
In two studies, the overall safety, tolerability, and treatment discontinuation rate of orforglipron were consistent with previous studies. The most common adverse events were gastrointestinal-related reactions, generally mild to moderate. No liver safety signals were observed.
About Orforglipron
Orforglipron is an investigational, once-daily oral small molecule (non-peptide) glucagon-like peptide-1 receptor agonist (GLP-1 RA). The medication can be taken at any time of the day without dietary or hydration restrictions. It was discovered by Chugai Pharmaceutical Co., Ltd. and licensed to Eli Lilly and Company for development in 2018. Chugai Pharmaceutical and Eli Lilly jointly published the preclinical pharmacological data of this molecule. Currently, Eli Lilly is conducting a series of Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in overweight adults with obesity or at least one weight-related comorbidity. Additionally, Eli Lilly is exploring the potential use of orforglipron in treating obstructive sleep apnea, hypertension, and osteoarthritis pain in adults with obesity.