Recently, across ChinaBallPeptideAnd FewNucleotide (TIDES）Field WelcomingComeSeriesInExpand。Johnson & Johnson announced itsOralResults of Two Clinical Trials on the Polypeptide Therapy Icotrokinra, inPlaque Psoriasis andActive UlcerUlcerative ColitisPositive efficacy data were achieved in all patients.Wave Life SciencesLong-acting siRNA Weight Loss TherapyWVE-007 ObtainedPositive Clinical Data,Has the potential for once or twice a year dosing.PublishThisWenA brief introduction to some of the important advances will be excerpted.For readers' reference.

Icotrokinra: Announcement of Data from Two Clinical Trials

Johnson & JohnsonAnnounced positive data from two clinical trials of its targeted oral peptide icotrokinra.Icotrokinra can selectively block the IL-23 receptor (IL-23R).IL-23 is the basis of inflammatory responses in psoriasis and other skin diseases, rheumatic diseases, and IL-23-mediated gastrointestinal diseases.Icotrokinra can bind to IL-23R with high affinity and exert a potent selective inhibitory effect on IL-23 signaling transduction in human T cells.It is worth mentioning that icotrokinra was named one of the top ten star molecules of 2024 by the well-known industry media Drug Hunter earlier this year.

In the phase 3 clinical trial ICONIC-TOTAL for adult and plaque psoriasis patients aged 12 years and above,Patients with scalp psoriasis and genital psoriasis treated with icotrokinra achieved IGA 0/1 (complete or almost complete skin clearance) at week 52, with rates of 72% and 85%, respectively.; 67% of patients achieved IGA 0/1 score at week 24 and maintained it until week 52. As a once-daily oral medication, icotrokinra continues to demonstrate excellent skin lesion clearance and good safety, showing significant therapeutic potential.

In the Phase 2b study ANTHEM-UC involving adult patients with moderate to severe active ulcerative colitis, icotrokinra continued to demonstrate clinically meaningful efficacy at Week 28.The results showed,In the 400 mg dose group,66.7%Patients with moderate to severe ulcerative colitis achieved clinical response,31.7% achieved clinical remission, 38.1% achieved endoscopic improvement, and the efficacy was superior to placebo.All icotrokinra dose groups (100 mg, 200 mg, and 400 mg) demonstrated superiority over the placebo group in terms of clinical remission rate, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI), with sustained efficacy from week 12 to week 28. These results further support the phase 3 clinical development of icotrokinra for ulcerative colitis and Crohn's disease.

▲Results of the ANTHEM-UC Study (Image Source: Reference [3])

WVE-007: Announcement of Phase 1 Clinical Trial Data

Wave Life Sciences Announces Latest Data from Ongoing INLIGHT Clinical Trial Evaluating WVE-007 for Obesity TreatmentWVE-007 is a long-acting GalNAc-modified siRNA that targets a genetically validated target.INHBEmRNA. WVE-007 is designed to inhibitINHBETo reduce fat accumulation while preserving muscle mass.

The results published this time show,In all three dose-escalation cohorts, a dose-dependent and highly significant reduction in Activin E levels was observed (p<0.0001 for all dose groups). On Day 29 following a single dose, the mean reductions in Activin E levels were 85%, 75%, and 56% in the 400 mg, 240 mg, and 75 mg dose groups, respectively.Among them,The inhibition levels in the 240 mg and 400 mg dose groups have exceeded the threshold associated with fat reduction in previous preclinical studies.In addition,In the 75 mg dose group, the decline in Activin E remained sustained over a six-month follow-up period, indicating the potential for WVE-007 to be administered once or twice a year.In terms of clinical safety, WVE-007 is currently well-tolerated, and the independent data monitoring committee has supported the expansion of the 600 mg dose cohort as well as exploration of higher doses.

Mashutide: Phase 3 Clinical Trial Data Released

Innovent Biologics announced that the fourth Phase 3 clinical trial, DREAMS-3, of its glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist, mazdutide, has achieved its primary endpoint. The study results demonstrated,In Chinese subjects with type 2 diabetes and obesity, at week 32, the Masglutide groupGlycated Hemoglobin (HbA1c)The proportion of subjects with <7.0% and a weight decrease ≥10% from baseline was 48.0%, superior to the active control group (21.0%, P value <0.0001).Moreover, at Week 32, the mean changes in HbA1c from baseline were −2.03% and −1.84% for the masitope group and active comparator group, respectively, while the mean percentage reductions in body weight from baseline were 10.29% and 6.00%, respectively (both P-values < 0.05). The overall safety profile of masitope during the study period was consistent with previous clinical studies, with no new safety signals identified. Gastrointestinal adverse reactions were the most common adverse events, mostly mild or moderate in severity.

Mashidu Peptide is developed by Innovent Biologics and Eli Lilly（Eli Lilly and Company）A GCG/GLP-1 dual receptor agonist weight-loss drug jointly advanced, which has a unique dual agonist mechanism of action. While activating GLP-1 receptors to suppress appetite, it simultaneously activates GCG receptors, promoting fat burning, reducing visceral fat content, and further enhancing the weight-loss effect of MASH peptide.Mashiduo peptide has demonstrated excellent weight loss and blood sugar lowering efficacy in multiple clinical studies, as well as reductions in waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, and liver fat content, while improving insulin sensitivity, bringing multiple metabolic benefits.The therapy has been approved in China for two indications, including long-term weight control in adult patients with obesity or overweight and at least one weight-related comorbidity, as well as glycemic control in adult patients with type 2 diabetes.

$12 Billion! Novartis Acquires Avidity Biosciences

Novartis recently announced an agreement to acquire Avidity Biosciences for approximately $12 billion.This transaction will be completed after Avidity spins off its early-stage precision cardiology program. Avidity is dedicated to developing novel RNA therapies in the antibody oligonucleotide conjugate (AOC) class for the treatment of severe hereditary neuromuscular diseases.This acquisition will enable Novartis to gain Avidity's late-stage neuroscience programs and introduce a differentiated RNA-targeted delivery platform., further enriching its neuroscience R&D portfolio. This acquisition is expected to advance Novartis' neuroscience strategy and complement its pipeline with a potential "first-in-class" therapy targeting the genetic drivers of muscle damage diseases.

This acquisition will bring Novartis three late-stage projects targeting hereditary neuromuscular diseases.These include: Type I Myotonic Dystrophy (DM1), a rare progressive disease with no current effective disease-modifying therapy; Facioscapulohumeral Muscular Dystrophy (FSHD), a rare genetic disorder leading to persistent loss of muscle function; and Duchenne Muscular Dystrophy (DMD), a severe early-onset condition characterized by progressive muscle damage and shortened lifespan.

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