Editor's Note:In recent years, oligonucleotide and peptide (TIDES) therapies have developed rapidly, accounting for a stable 10% of FDA-approved new drugs. Reviewing the overall R&D progress in the industry, the global pipeline of TIDES therapies has reached thousands of projects and continues to expand. In response to the growing R&D demands from the industry, WuXi TIDES, a platform under WuXi AppTec, supports global partners in transforming innovative ideas into accessible therapies by providing R&D and manufacturing services for oligonucleotides, peptides, and related compounds, bringing patients more timely and effective treatment options. In this article today, we will share with our readers the latest developments in the field of TIDES therapies.

Recently, the global peptide and oligonucleotide (TIDES) field has seen a series of advancements.Johnson & Johnson(Johnson & Johnson) CompanyUsed for treatmentPlaque Psoriasis (PsO)Oral PolypeptidePositive results from the Phase 3 clinical trial of icotrokinra,At Week 24, nearly 90% of adolescent patients achievedClear or nearly clear skin symptoms（IGA 0/1）。Palatin Technologies Announces Its Peptide Combination TherapyResults of the Phase 2 Clinical Trial of Bremelanotide in Combination with Tirzepatide,PatientAppetite suppression increased by over 70%。Merck & Co., Inc. (MSD) &Cyprumed Inks Nearly $500 Million Deal to Develop Oral Peptide Drugs.

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Icotrokinra (JNJ-2113): Phase 3 Clinical Trial Data Released

Johnson & Johnson announced positive results from its pivotal Phase 3 study, ICONIC-LEAD, which aimed to simultaneously evaluate the safety and efficacy of icotrokinra in adolescents and adults. According to the press release, icotrokinra is the first investigational targeted oral peptide designed to block IL-23R and is currently being evaluated in adults and adolescents aged 12 years and older with moderate to severe PsO.Icotrokinra can bind to IL-23R with single-digit picomolar affinity and exerts potent selective inhibition of IL-23 signaling in human T cells.

The analysis shows,84.1% of adolescent patients with moderate to severe plaque psoriasis achieved IGA 0/1 at week 16 after receiving daily treatment with icotrokinra.70.5% of patients achieved at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90), compared to only 27.3% and 13.6% in the placebo group for these two metrics, respectively.The remission rate continued to increase at week 24, with 86.4% of adolescent patients achieving IGA 0/1 and 88.6% achieving PASI 90.Moreover, at week 24, 75% of adolescent patients achieved IGA 0, and 63.6% achieved PASI 100. In terms of safety, Icotrokinra continued to demonstrate a favorable safety profile, with no new safety signals identified.

Development of Oral Peptide Drugs: MSD Reaches Nearly $500 Million Collaboration

Cyprumed is eligible to receive upfront, R&D, regulatory, and commercialization milestone payments of up to $493 million. If MSD exercises its exclusive license option, Cyprumed may also receive additional payments. According to the agreement, MSD will be responsible for the R&D, manufacturing, and commercialization of any products developed using Cyprumed's delivery technology.

Bremelanotide, Tirzepatide: Phase 2 Clinical Trial Data Released

Palatin Technologies announced positive results from its Phase 2 clinical trial, BMT-801. The study evaluated the effects of the combination of the melanocortin-4 receptor (MC4R) agonist bremelanotide with the GLP-1/GIP dual agonist tirzepatide, as well as bremelanotide monotherapy and tirzepatide monotherapy.

The study results showed that the bremelanotide combination with tirzepatide group, tirzepatide monotherapy group, and bremelanotide monotherapy group all demonstrated significant improvements in appetite suppression, increased satiety, and satisfaction. Among them,The combination group showed a 71% increase in appetite suppression, a 65% increase in satiety, and a 56% increase in satisfaction.Notably, the appetite-suppressing effect disappeared in patients who switched to placebo after discontinuing tirzepatide, and more than 50% of the weight loss rebounded within two weeks of stopping the medication. However,Patients who switched to a low dose of bremelanotide after weight loss with tirzepatide did not experience significant weight rebound, indicating the potential of MC4R agonists as a long-term weight maintenance therapy.Previously released preliminary results showed that the combination group achieved statistically significant weight loss compared to the placebo group during the 8-week treatment period.

Limited by space,This article only provides a brief introduction to some significant advancements.。Readers are welcome to long press/scan the following QR code to apply for the "TIDES Therapy Progress Review, April 2025, Issue 3" containing a complete table summary.

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[1] Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill. Retrieved April 18, 2025, from https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill

[2] Cyprumed Enters License and Option Agreement with MSD for the Development of Oral Peptide Therapeutics. Retrieved April 15, 2025, from https://www.globenewswire.com/news-release/2025/04/15/3061402/0/en/Cyprumed-Enters-License-and-Option-Agreement-with-MSD-for-the-Development-of-Oral-Peptide-Therapeutics.html

[3] Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide. Retrieved April 18, 2025, from https://www.prnewswire.com/news-releases/palatin-reports-positive-appetite-suppression-results-from-phase-2-obesity-study-of-mc4r-agonist-bremelanotide-and-tirzepatide-302431194.html