Corteria Pharmaceuticals Submits IPO Filing Highlighting First-in-Class CRF2 Receptor Agonists for Muscle-Sparing Fat Loss and Heart Failure

2025-07-21 United States, Johnson & Johnson announced that it has submitted the NDA for Icotrokinra to the FDA for the treatment of patients aged 12 years and older with moderate to severe plaque psoriasis. This first-in-class targeted oral peptide drug, co-developed with Protagonist Therapeutics, selectively blocks the IL-23 receptor and is expected to transform the current landscape of psoriasis treatment.

This application is based on data from four pivotal Phase III clinical trials (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2) of Johnson & Johnson's ICONIC program. Icotrokinra achieved primary and co-primary endpoints in all studies, demonstrating significant skin clearance rates and excellent safety, while offering the convenience of an oral medication. Notably, in two head-to-head trials, Icotrokinra showed significantly superior efficacy compared to the oral TYK2 inhibitor Deucravacitinib, highlighting its potential as a first-in-class drug.

Clinical data show that the proportion of patients treated with Icotrokinra who achieved IGA 0/1 (clear or almost clear skin) and PASI 90 (more than 90% improvement in skin lesions) at week 16 was significantly higher than in the placebo group. Across all studies, the incidence of drug-related adverse events was comparable to placebo (49.1% vs. 51.9%), with no new safety signals observed. Additionally, Icotrokinra demonstrated significant advantages in treating some "difficult-to-treat areas." For example, in the ICONIC-TOTAL study, effective relief was also achieved in sensitive areas such as the scalp, perineum, and hands and feet. In a subgroup analysis of adolescents, patients aged 12 years and above showed efficacy comparable to that in adults.

Currently, Johnson & Johnson has also launched the ICONIC-ASCEND study, which is the first Phase III head-to-head study comparing the efficacy of an oral medication with an injectable biologic (ustekinumab).

Paris, July 21, 2025 — Clinical-stage biopharmaceutical company Corteria Pharmaceuticals announced that its two first-in-class CRF2 receptor agonists, COR-1167 and COR-1389, have achieved key clinical progress in the fields of heart failure and obesity treatment, respectively.

Among them, COR-1167 is a daily subcutaneous injectable CRF2 peptide agonist designed for the treatment of worsening heart failure (WHF). In previous Phase I clinical trials, the drug demonstrated good safety and tolerability in both healthy volunteers and patients with chronic heart failure. A single dose was able to achieve significant activation of the CRF2 target, improve multiple cardiac function indicators, without adversely affecting blood pressure. Based on the positive early data, Corteria Pharmaceuticals has now initiated the CRAFT-WHF Phase II clinical study, which will treat 300 WHF patients over a one-month period to evaluate the efficacy of different doses of COR-1167 in terms of safety and cardio-renal function improvement. The main study results are expected to be announced by the end of 2026.

Another pipeline product, COR-1389, is a long-acting, once-weekly subcutaneous injectable CRF2 peptide agonist specifically designed for treating obesity-related heart failure and right-sided heart failure caused by pulmonary arterial hypertension (Group 2 PH). The drug is currently in Phase I clinical trials, having completed single ascending dose testing, and is now in a 12-week multiple ascending dose phase to evaluate its safety and efficacy in obese subjects. Relevant indicators include changes in body weight and assessments of fat and muscle composition via whole-body MRI. Primary data is expected to be released in 2H 2026.

In animal experiments, COR-1389 demonstrated significant metabolic improvements in high-fat diet-induced obesity models, increasing energy expenditure, reducing fat, and enhancing muscle mass. Its weight-loss effects are comparable to GLP-1 agonists. Notably, when combined with tirzepatide or semaglutide, COR-1389 not only further promotes fat reduction but also prevents the common issue of muscle loss associated with GLP-1 drugs. Additionally, COR-1389 showed remarkable improvements in cardiopulmonary function in a right heart failure animal model, reversing adverse remodeling of the right ventricle and pulmonary arteries. Corteria Pharmaceuticals plans to initiate a Phase Ib clinical trial to evaluate its acute hemodynamic improvement effects in Group 2 PH patients, with results expected to be released in 2H 2026.

2025-07-22 United States: ReAlta Life Sciences’ investigational drug pegtarazimod (RLS-0071) has demonstrated potent anti-inflammatory activity in an animal model of neonatal hypoxic-ischemic encephalopathy (HIE). Recent studies show that the drug effectively inhibits microglial recruitment and myeloperoxidase (MPO)-mediated neuroinflammation, providing further mechanistic support for the company’s ongoing mid-stage clinical trials. The findings were recently published in the *American Journal of Perinatology*. Data indicate that, in a neonatal rat model of ischemia-reperfusion, pegtarazimod significantly reduced microglial activation counts, decreased MPO expression, and increased neuronal density within 48 hours. Its efficacy was comparable to the current standard treatment—therapeutic hypothermia—and showed enhanced effects when used in combination.

Pegtazimod is a peptide molecule containing 15 amino acids, derived from research on human astrovirus. It has a unique dual mechanism of action, capable of simultaneously targeting the early activation point of the complement cascade (C1 complex) and MPO-mediated extracellular trap (NETs) formation. In HIE, these two mechanisms are considered the core inflammatory pathways following ischemia-reperfusion injury.

ReAlta Plans to Announce Interim Clinical Data from the STAR Trial in 2H 2025, While Actively Advancing the Development of the Drug in Inflammatory Indications Such as Acute Graft-Versus-Host Disease (aGvHD) and Chronic Obstructive Pulmonary Disease (COPD). Currently, the Company Has Received Multiple Orphan Drug and Fast Track Designations for RLS-0071 from the FDA.

2025-07-22, Lilly's Bimagrumab Injection registered a clinical trial in CTR (CTR20252857), which is a study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of Bimagrumab. The indication is for weight management in individuals who are obese or overweight with at least one weight-related comorbidity.

Bimagrumab is a fully human monoclonal antibody targeting Activin Type II receptor (ActRII), and it is the first drug of its kind in this field. ActRII plays a key role in regulating muscle growth and fat metabolism. After the natural ligand binds to ActRII, it negatively regulates skeletal muscle growth. By tightly binding to ActRII, Bimagrumab blocks the action of the natural ligand, which not only prevents muscle atrophy but also promotes an increase in muscle mass.

Bimagrumab was initially developed by Novartis. Novartis acquired the drug through MorphoSys' antibody screening platform. In 2019, Novartis transferred Bimagrumab to the newly established biotech company Aditum Bio. Subsequently, Versanis spun off from Aditum Bio to specifically advance the further development of Bimagrumab. In July 2023, Lilly acquired Versanis for nearly $2 billion, gaining global rights to Bimagrumab and continuing to advance its clinical research and other related work.

On 2025-07-22, Aoli Biotech's OLP-210 tablets were registered for a clinical trial (CTR20252854) in the CTR. This is a Phase I study evaluating OLP-210 tablets in healthy Chinese subjects, obese and overweight patients.

Aoli Biotech is a holding subsidiary of BrightGene Bio-Medical Technology, established in August 2022. It is a high-tech enterprise focusing on the research and development of oral delivery technology for biopharmaceuticals, with its technical platform being the Macoral® oral macromolecule drug delivery technology. It is speculated that OLP-210 tablets are an oral semaglutide tablet developed by Aoli Biotech for weight management.

On 2025-07-23, Zhenzhong Ruichuang's RAY1225 Injection was registered for a clinical trial (CTR20252928) in the CTR, which is a DDI study of RAY1225 Injection. The indications are for overweight/obese patients and type 2 diabetes patients.

Ray1225 Injection is a long-acting GIP and GLP-1 dual-target agonist, a novel peptide drug independently developed by Guangdong Zhongsheng Ruichuang. It promotes insulin secretion and inhibits glucagon in a glucose-dependent manner. Additionally, it has effects such as inhibiting gastric emptying, suppressing appetite, reducing body weight, decreasing peripheral insulin resistance, and improving steatosis. Phase II clinical trials have shown significant weight loss effects and good safety.

On 2025-07-25, Lilly's Orforglipron tablets were registered for a clinical trial (CTR20252894) in the CTR. This is a study to evaluate the efficacy and safety of Orforglipron tablets in obese or overweight participants. The indication is for long-term weight management in adults. On the same day, Lilly's Orforglipron tablets were registered for another clinical trial (CTR20252895) in the CTR, which is a study to evaluate the efficacy and safety of Orforglipron tablets in participants with type 2 diabetes. The indication is for adult type 2 diabetes.

On 2025-07-28, Lilly's tirzepatide injection received the registration and marketing approval certificate issued by the NMPA, with the approval numbers HJ20240020, HJ20240023, HJ20240021, and HJ20240022. This approval is for a new indication of tirzepatide: to be used in combination with insulin (with or without oral hypoglycemic agents) on the basis of diet control and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM).

On 2025-07-28, Nuotai Aosainuo's Cetrorelix Acetate for Injection received the registration and market approval certificate issued by NMPA, with the approval number H20254895.

On 2025-07-28, Chongqing Pharma Yaoke's Vancomycin Hydrochloride for Injection received the registration and market approval certificate issued by the NMPA, with the approval number H20254904.

On 2025-07-28, Chenxin Pharmaceutical's Ganirelix Acetate Injection received the registration and market approval certificate issued by NMPA, with the approval number H20254901.