Novo Nordisk Partners with Valo Health to Accelerate AI-Driven Discovery of Cardiometabolic Therapies

2025-01-08, Novo Nordisk and Valo Announce Expanded Collaboration to Develop Novel Therapies for Cardiometabolic Diseases. This collaboration is based on Valo's extensive human datasets and artificial intelligence (AI)-driven computational capabilities.

The two parties initially established a partnership in 2023, aiming to leverage Valo Health's Opal computational platform to accelerate the discovery and development of treatments for cardiometabolic diseases.

Under the expanded agreement, Valo Health and Novo Nordisk will jointly develop up to 20 drug programs (with 9 newly added). In addition, Valo will receive an upfront payment of approximately $190 million and is eligible for milestone payments of up to $4.6 billion, as well as research and development funding and potential royalties.

2025-01-09, Verdiva, a company focused on developing innovative therapies for obesity and cardiometabolic diseases, officially announced its establishment, while completing a Series A financing round of over $410 million. The round was co-led by Forbion and General Atlantic, with participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital.

Verdiva Obtains Global Development and Commercialization Rights Outside Greater China and Korea for Sciwind’s Portfolio, Planning to Advance Next-Generation Therapies Including Once-Weekly Oral GLP-1 Receptor Agonists and Oral Amylin Agonists. The company's most advanced program, VRB-101, an oral GLP-1 peptide, has demonstrated best-in-class efficacy potential in Phase 1 clinical trials in Australia and confirmed the feasibility of once-weekly dosing. Additionally, Verdiva is developing a range of Amylin molecules, including both oral and subcutaneous agonists, along with other undisclosed projects.

On January 10, 2025, Sciwind announced a global licensing and collaboration agreement with Verdiva to jointly develop and commercialize a portfolio of metabolic disease treatments.

The drug combinations involved in this collaboration include:

① Oral Ecnoglutide (XW004): A first-in-class once-weekly oral GLP-1 receptor agonist, currently in preparation for Phase 2 clinical trials;

② Oral Amylin Receptor Agonist: A first-in-class, once-weekly, long-acting oral Amylin receptor agonist currently undergoing IND-enabling studies;

③ Subcutaneous injection of Amylin receptor agonist: A best-in-class long-acting Amylin receptor agonist, currently undergoing IND-supportive studies.

Under the agreement, Sciwind grants Verdiva exclusive global rights to develop, manufacture, and commercialize these collaboration projects outside of Greater China and South Korea. Sciwind will receive an upfront payment of approximately US$70 million and is eligible for over US$2.4 billion in development, regulatory approval, and commercialization milestone payments, in addition to tiered royalties on future product sales outside of Greater China and South Korea. The two companies will also collaborate on the development of additional preclinical stage projects, with Sciwind eligible to receive milestones and royalties based on the progress of these programs.

On January 6, 2025, the CDE website showed that the clinical trial application for "Semaglutide Injection" by Zhongshan Wanhhan Pharmaceutical has been accepted.

On January 7, 2025, the CDE official website showed that Suzhou Jingze Bio's "Recombinant Human Follicle-Stimulating Hormone-CTP Fusion Protein Injection" had received clinical trial implied permission from the CDE.

Recombinant Human Follitropin-CTP Fusion Protein Injection is a long-acting recombinant human follitropin, mainly used for female assisted reproductive treatment. The drug promotes the development of multiple follicles through controlled ovarian stimulation (COS), achieving pro-reproductive effects.

Among them, CTP is the carboxy-terminal peptide of the beta subunit of human chorionic gonadotropin. The early discovery of CTP was due to the observation that both chorionic gonadotropin and luteinizing hormone have similar structures but significantly different half-lives, which are 2 days and 20 minutes, respectively. The difference in chorionic gonadotropin lies in its HCG beta subunit (HCG-b), which contains a 31-amino acid residue CTP. This CTP consists of the sequence FQSSSS*KAPPPS*LPSPS*RLPGPS*DTPILPQ and has four O-glycosylation sites (indicated as S*), ending with sialic acid residues. It can increase the sialic acid content of recombinant fusion proteins. Sialic acid enhances the viscosity of mucins, masking the glycan chains on proteins, preventing their hydrolysis by glycosidases, and protecting the proteins from protease degradation. At the same time, it increases the degree of protein glycosylation and molecular weight, thus achieving a longer drug half-life in vivo. Additionally, CTP is a natural long-acting fusion partner in the human body, so its immunogenicity is very low.

On 2025-01-06, Jiangsu Hengsen Pharmaceutical registered a study on the CTR platform to evaluate the effect of HS-20094 on the pharmacokinetics of warfarin in overweight or obese participants.

Among them, HS-20094 is a novel dual agonist of glucagon-like peptide-1 receptor (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor. The drug selectively activates GLP-1 and GIP receptors, promoting insulin secretion, delaying gastric emptying, and suppressing appetite to reduce food intake, thereby generating biological effects such as blood sugar control, weight loss, and metabolic improvement. HS-20094 is administered once weekly via subcutaneous injection.

2025-01-07, MBX Biosciences announced positive topline results from the Phase 1 clinical trial of its candidate drug MBX-1416 for the treatment of post-bariatric hypoglycemia (PBH).

Results:

MBX-1416 demonstrated good safety and tolerability, with no serious adverse events observed;

MBX-1416 demonstrates ideal pharmacokinetic properties, supporting once-weekly subcutaneous injection administration.

Among them, MBX-1416 is a long-acting GLP-1 receptor antagonist, mainly used for the treatment of post-bariatric hypoglycemia (PBH). The drug prevents and treats severe hypoglycemic events in PBH patients by blocking the GLP-1 receptor and reducing excessive GLP-1 secretion. PBH is a rare but serious postoperative complication associated with weight-loss surgeries such as gastric bypass, and currently, there are no FDA-approved treatment options available. MBX Biosciences plans to initiate the Phase 2 clinical trial of MBX-1416 in the second half of 2025.

On January 7, 2025, Metsera announced positive results from the 12-week Phase 2a clinical trial of its ultra-long-acting GLP-1 receptor agonist, MET-097i.

Results:

Weight loss was dose-dependent, with an average weight reduction of 11.3% (placebo-adjusted) after 12 weekly doses in the 1.2mg dose cohort, and individual responses reaching up to approximately 20%;

No weight loss plateau was observed, indicating potential for additional weight loss with long-term dosing.

All cohorts achieved clinically meaningful and statistically significant weight loss after the 12-week dosing.

This trial is a randomized, double-blind, placebo-controlled Phase 2a trial that enrolled a total of 120 participants who were obese or overweight and did not have type 2 diabetes. MET-097i was tested across five cohorts, with 24 participants in each cohort (20 receiving the active drug and 4 receiving the placebo). In four cohorts, participants received weekly doses of 0.6mg, 0.8mg, 1.0mg, or 1.2mg for 12 weeks without titration. Participants in the fifth cohort also received a weekly dose, but with a gradual increase: 0.4mg for the first 4 weeks, 0.8mg for the next 4 weeks, and 1.2mg for the final 4 weeks. At week 13, all participants had their doses increased two-fold or four-fold to assess the tolerability of transitioning to a potentially pharmacologically equivalent monthly dose.

Among them, MET-097i is Metsera's most advanced candidate product, a fully biased, potential, once-monthly, ultra-long-acting, subcutaneously injected GLP-1 receptor agonist. MET-097i incorporates Metsera's HALO™ platform technology, with an initial half-life of 15-16 days, supporting once-monthly dosing and administration with or without titration. MET-097i is currently undergoing a Phase 2b monotherapy study and is planned to be evaluated in combination with Metsera's ultra-long-acting amylin analog MET-233i and other ultra-long-acting nutrient-stimulated hormone (NuSH) analog peptide injectables in future studies.

2025-01-07, Biomea Fusion, dedicated to the discovery and development of oral covalent small molecules, announced the latest preclinical data for icovamenib in combination with semaglutide.

Preclinical data show:

Icovamenib in combination with semaglutide resulted in an additional 11.5% reduction in body weight and a 43% increase in lean muscle mass compared to semaglutide alone.

In addition, the combination therapy also doubled the amount of C-peptide produced, thereby reducing fasting blood glucose levels by 60%.

Icovamenib enhances the activity of GLP-1-based therapies, leading to a significant increase in insulin secretion.

Topline data from the COVALENT-111 study indicate that for patients with inadequate glycemic control on GLP-1 basal therapy, daily use of icovamenib over 12 weeks resulted in a 0.84% reduction in HbA1c by Week 26.

2025-01-08, Nuvie Bio announced positive results from the Phase 1 clinical trial of its leading migraine project, NVI-100.

The results showed that: NVI-100 was well tolerated and rapidly achieved high and consistent plasma levels.

Among them, NVI-100 is a first-in-class water-soluble peptide CGRP receptor antagonist administered via autoinjector for the acute treatment of migraine. NVI-100 was initially discovered by Ferring Pharmaceuticals and is now globally owned by Nuvie Bio, which holds exclusive development and commercialization rights. Nuvie Bio plans to submit an Investigational New Drug (IND) application for NVI-100 in Phase 2 clinical trials in 2025.

2025-01-08, Arch Announces Approval from the Ontario Research Ethics Board to Advance Phase 2 Clinical Trial of LSALT Peptide for Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI).

The CS-AKI Phase 2 trial is an international, multicenter, randomized, double-blind, placebo-controlled study planning to enroll 240 patients. The primary objective is to assess the proportion of patients with acute kidney injury (AKI), as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria, within seven days after cardiac surgery involving cardiopulmonary bypass (heart-lung machine).

Among them, LSALT peptide is Arch's main drug candidate for the prevention and treatment of inflammatory injuries in the kidneys, lungs, and liver. The drug targets the dipeptidase-1 (DPEP1) pathway, and Arch's scientists and their collaborators have demonstrated in preclinical models that it can prevent ischemia-reperfusion injury (IRI) in the kidneys, providing a scientific basis for the use of LSALT peptide in the current CS-AKI trial.

On January 10, 2025, Regor announced positive results from the Phase 2a clinical trial of its orally administered small molecule GLP-1 receptor agonist RGT-075 for the treatment of obesity.

Results:

Patients receiving 125 mg of RGT-075 daily achieved a 5% weight loss relative to placebo over 12 weeks (with 6 weeks at the target dose) without reaching a plateau.

In terms of safety, no serious adverse events related to the treatment were observed. The discontinuation rate due to adverse events was 4%, the same as in the placebo group. In the treatment group, 40% of patients reported mild to moderate nausea and 24% reported vomiting. Only one patient (2%) required a dose reduction, but she successfully completed the study at a daily dose of 60 mg.

Based on these results, Regor has initiated a Phase 2b dose-finding study named COMO-1 in the United States to optimize the dosage and further evaluate the efficacy and safety of RGT-075. The results of this study are expected to be announced in the fourth quarter of 2025.

Among them, RGT-075 is a small-molecule GLP-1 receptor agonist taken orally once daily, mainly used for the treatment of obesity and type 2 diabetes. The drug exerts its therapeutic effects by activating the GLP-1 receptor, improving glucose tolerance, and reducing food intake.

On 2025-01-13, Federal Bio registered the Phase II clinical trial of "UBT251 Injection" for type 2 diabetes on the China Drug Clinical Trial Registration and Information Platform (CTR).

Among them, UBT251 injection, developed by Federal Pharmaceutical, is a long-acting GLP-1/GIP/GCG triple receptor agonist, mainly used for the treatment of type 2 diabetes, overweight/obesity, and non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH).

2025-1-8, Viking Therapeutics announced the initiation of the Phase II clinical trial for VK2735.

This trial is a 13-week randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of VK2735 in weight reduction. Approximately 280 adults classified as obese or overweight with weight-related complications will be enrolled. Participants will be randomly assigned to one of six dosage groups or a placebo group. The primary objective of the study is to determine the percentage change in body weight from baseline after 13 weeks of treatment, with secondary and exploratory endpoints including additional safety and efficacy measures. In this study, VK2735 demonstrated dose-dependent weight loss and a favorable safety profile.

Among them, VK2735 is a dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. It is an oral medication designed to treat obesity and related metabolic diseases.