Recently, Rein Therapeutics (referred to as "Rein", NASDAQ stock code: RNTX), a biopharmaceutical company, announced that it has been authorized by the European Medicines Agency (EMA) to launch phase 2 "RENEW" clinical trials of its core candidate drug LTI-03 for the treatment of idiopathic pulmonary fibrosis (IPF).
This authorization covers clinical trial centers in Germany and Poland, which will become key European sites for this global research. Previously, Rein had obtained regulatory approval from the Medicines and Medical Products Regulatory Authority (MHRA) in the UK.
The RENEW trial is a randomized, double-blind, placebo-controlled phase 2 study aimed at evaluating the safety, tolerability, and efficacy of LT1-03 in IPF patients. The study plans to enroll up to 120 patients worldwide, with two dose groups and a treatment duration of 24 weeks.
The key secondary endpoints include changes in lung function (forced vital capacity, FVC) and imaging based assessment of fibrosis progression. LT1-03 is a peptide drug derived from caveolin-1, which is designed to have a dual effect: it can inhibit fibrosis and support the regeneration of healthy lung tissue by protecting alveolar progenitor cells, which are crucial for lung repair.
About Rein Therapeutics
Rein Therapeutics is a biopharmaceutical company in the clinical stage, focusing on developing "first of its kind" innovative therapies to address significant unmet medical needs in rare lung diseases and fibrosis indications.
Johnson&Johnson plans to acquire Protagonist
Recently, according to foreign media reports, Johnson&Johnson is in talks to acquire its immunotherapy partner Protagonist Therapeutics (NASDAQ: PTGX) for an estimated transaction amount of over 28.5 billion yuan (approximately 4 billion US dollars). The core asset behind this acquisition is icotrokinra, an oral cyclic peptide IL-23 inhibitor that is about to change the treatment landscape of psoriasis.
The two companies are currently collaborating to develop an oral cyclic peptide L-23 inhibitor icotrokinra for the treatment of immune diseases such as plaque psoriasis and ulcerative colitis. Johnson&Johnson has exclusive commercial authorization for this product. Johnson&Johnson's immunology heavyweight drug Ste lara recently lost its patent exclusivity in the United States, and the company submitted a new drug application to the FDA in July seeking approval for icotrokinra for the treatment of plaque psoriasis. If this transaction is completed, it will help Johnson&Johnson consolidate its product line as its heavyweight immunotherapy drug Stelara faces competition from low-priced generic drugs.
The drug achieved success in two phase 3 trials of plaque psoriasis at the end of last year. Johnson&Johnson CEO J0aquin Duato stated at an investor conference in September 2024 that if approved, the project would have a significant impact on the market.
Johnson&Johnson and Protagonist are seeking to extend it to several other immune and inflammatory diseases. Earlier this year, they announced the success of icotrokinra in a phase 2b trial of ulcerative colitis. In addition, Protagonist announced on Thursday that a phase 3 study targeting UC and a phase 2/3 study targeting Crohn's disease have been launched.
Icotrokinra is a targeted oral peptide that selectively blocks IL-23 receptor (1L-23R). IL-23 plays a crucial role in the pathogenic T cell activation of moderate to severe plaque psoriasis, and is the basis for the inflammatory response mediated by IL-23 in psoriasis and other skin diseases, rheumatism, and gastrointestinal diseases. 1cotrokinra can bind to I-er-23R with high affinity and exhibit potent selective inhibition of L-23 signaling transduction in human T cells.
GLP-1R/GIPR dual target agonist peptide ASC35 from Geli Pharmaceutical has entered the clinical development stage
On October 13, 2025, Geli Pharmaceutical Co., Ltd. (Hong Kong Stock Exchange code: 1672, abbreviated as "Geli") announced that it has selected ASC35, a potential best in class monthly subcutaneous injection GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual target agonist peptide, as a clinical development candidate drug. Geli is expected to submit an Application for Clinical Trial (IND) of ASC35 for the treatment of obesity to the US Food and Drug Administration (FDA) in the second quarter of 2026.
ASC35 is a GLP-1R and GIPR dual target agonist peptide independently developed using the Artificial Intelligence Assisted Structure Based Drug Discovery (AISBDD) and Ultra Long Acting Drug Development Platform (ULAP) technologies of Geli. In vitro experiments have shown that ASC35 exhibits approximately four times stronger excitatory activity towards GLP-1R and GIPR than tilboptin. Compared with the once weekly administration of tiltrotide, ASC35, which has been designed and optimized, achieves a longer apparent half-life (calculated as the time required for blood drug concentration to drop to 50% of Cmax) and higher bioavailability per milligram of peptide, thus supporting subcutaneous administration once a month with a daily injection volume not exceeding 1 milliliter.
These optimized features make it more cost-effective in large-scale production
ASC35 is being developed as a single drug and combination therapy for the treatment of cardiac metabolic diseases, including obesity, diabetes and metabolic dysfunction associated steatohepatitis (MASH). Golly plans to combine GLP1R/GIPR dual target agonist ASC35 with amylin receptor agonist ASC36 administered subcutaneously once a month to treat obesity and diabetes. Geli also plans to combine ASC35 with monthly subcutaneous administration of fat targeted thyroid receptor B (THR β) agonist ASC47 for the treatment of various metabolic diseases such as obesity and metabolic dysfunction related steatohepatitis.
