TIDES Weekly Recap | Global Peptide and Oligonucleotide Drug Highlights (Oct 19–25)

October 17, 2024Day,Jiangsu Pulley Pharmaceutical Biotechnology Co., Ltd. ("Pulley Pharma") announced: The company's Class 1 new antibiotic drugThe Phase II clinical trial of peptide PL-18 suppository conducted in China has recently completed the first subject enrollment and dosing. The follow-up on the efficacy and safety of the subjects is currently underway.

This study is a multi-center, randomized, double-blind Phase II clinical trial aimed at evaluating the safety, tolerability, and efficacy of multiple administrations of antimicrobial peptide PL-18 suppositories in patients with vulvovaginal candidiasis (VVC). This clinical study has been approved by the National Medical Products Administration and has received ethical approval from multiple centers in China. Various clinical research activities are currently being actively carried out. This product primarily targets bacteria,Development of gynecological vaginitis caused by fungal infections, intended for the treatment of conditions such as vulvovaginal candidiasis.

About Pulley Pharma

Jiangsu Pulai Pharmaceutical Biotechnology Co., Ltd. is a high-tech biopharmaceutical enterprise mainly engaged in the research and production of innovative peptide drugs. The company owns internationally leading platforms for de novo design of antimicrobial peptide drugs and innovative peptide formulation platforms. Its pipeline of drug candidates is extensive, including first-in-class innovative drugs for anti-infection, anti-tumor, autoimmune, and metabolic conditions, as well as various forms of peptide-based formulations such as sprays, suppositories, inhalants, and injectables. The company’s industrial base houses the world's first production lines for peptide sprays and peptide suppositories. It holds dozens of invention patents, and several projects have received support from China's National Science and Technology Major Project for "Key New Drug Creation."

October 21, 2024Day，Rigerna Announces Over RMB 100 Million in Angel+ Round Financing, Led by Shanghai Science Investment and Qihang Investment, with Follow-up Investments from Xincheng Fund, JSG United Runpu, Yuanxi Haihe, and Additional Investment from Existing Shareholder Sanyi Innovation Investment. The funds will primarily be used for the clinical research of the company’s first siRNA drug RG002C0106, advancement of multiple preclinical pipelines, and rapid development of non-liver tissue in vivo delivery technology and corresponding pipelines.Issue.

Rigerna was founded in 2022 and led by Dr. Huang Yuanyu, who has over 16 years of expertise in the nucleic acid pharmaceutical field. Dr. Huang previously worked for many years at a leading small nucleic acid pharmaceutical company, where he led the establishment of several small nucleic acid pharmaceutical technology platforms, advanced the development of multiple pipelines, and successfully brought them to clinical stages. He is among the earliest pioneers globally in nucleic acid drug research and one of the trailblazers in China’s small nucleic acid pharmaceutical industry.

Recently,ClinicalTrials website shows that Shengdi Pharmaceuticals, a subsidiary of Hengrui Pharma, has initiated a multicenter, randomized, open-label, parallel-controlled Phase III study (NCT06649344) of the GLP-1R/GIPR dual agonist HRS9531. This study aims to compare the efficacy and safety of HRS9531 versus semaglutide in type 2 diabetes subjects with inadequate glycemic control on metformin monotherapy or in combination with sodium-glucose co-transporter 2 (SGLT2) inhibitors.

The trial plans to recruit 840 patients, with an estimated completion time of March 2026. The primary endpoint is the change in HbA1c from baseline at week 32, and secondary endpoints include the percentage change in body weight from baseline at week 32, the proportion of subjects with HbA1c ≤6.5% and HbA1c <5.7%, and HbA1c <7.0%.And the proportion of subjects with weight loss ≥5% from baseline, as well as adverse events and hypoglycemic events at Week 36.

About Hengrui Pharma

Hengrui Pharma was founded in 1970 as an international pharmaceutical company engaged in the innovation, development, and promotion of medicines. The company focuses on new drug research and development in areas such as oncology, surgical medications, autoimmune diseases, metabolic disorders, and cardiovascular diseases.

On October 21, 2024, Novo Nordisk announced the primary results of the SOUL cardiovascular outcomes trial. This double-blind, randomized trial compared oral semaglutide (Rybelsus) versus placebo as an add-on to standard care for the prevention of major adverse cardiovascular events (MACE). The trial enrolled 9,650 patients with type 2 diabetes who had established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of the standard care, 49% of the patients received SGLT2i treatment at some point during the trial.

About Semaglutide

Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and food intake.

About Novo Nordisk

Novo Nordisk was founded in 1923 and is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes, obesity, rare blood diseases, endocrine disorders, and other serious chronic conditions. To achieve this, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, delivering products and services to more than 168 countries and regions globally.

RecentlyGilead Sciences and MSD announced the latest results of the phase 2 clinical trial for their long-acting HIV oral combination therapy, islatravir (ISL) and lenacapavir (LEN). Analysis showed that at 48 weeks, this innovative combination therapy maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in HIV patients. Detailed data from the study were presented at the 2024 Infectious Diseases Week (IDWeek) conference. This HIV oral combination therapy is currently under review in phase 3 clinical trials.

About Islatravir

Islatravir (MK-8591) is an innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) developed by Merck. Preclinical studies have shown that it can inhibit the function of HIV reverse transcriptase through multiple mechanisms. Its mechanism of action is different from currently approved anti-HIV therapies and traditional nucleoside reverse transcriptase inhibitors (NRTIs). Currently, Merck has launched several clinical trials to test its efficacy as a single-agent pre-exposure prophylaxis (PrEP) therapy and in combination with other antiviral therapies for the treatment of HIV infection.

About Gilead Sciences, Inc.

Gilead Sciences (Gilead Sciences, Inc.) is a biopharmaceutical company that has been committed to achieving breakthroughs in the pharmaceutical field for more than thirty years, with the goal of creating a healthier world for all humanity.The company is committed to developing innovative drugs for the prevention and treatment of life-threatening diseases, including AIDS, viral hepatitis, COVID-19, and cancer.Gilead operates in more than 35 countries worldwide, with its headquarters in Foster City, California.

October 21, 2024DayAstraZeneca and Ionis announced that Wainzua (Eplontersen) has received a positive recommendation from the European Medicines Agency's Committee for Human Medicinal Products (CHMP) for the treatment of adult patients with hereditary transthyretin-mediated amyloidosis who have stage 1 or stage 2 polyneuropathy (commonly referred to as hATTR-PN or ATTRv-PN).

The press release noted that if approved by the European Commission, Eplontersen will become the only drug authorized in the EU for the treatment of ATTRv-PN, and patients will be able to self-administer it monthly via an auto-injector.

Since 1993, AstraZeneca has always adhered to the original intention of being "patient-centered," rooted in science, continuously expanding the boundaries of science, and promoting innovative practices and sustainable development in areas such as drug research and development, production operations, and business models. Over the past thirty years, AstraZeneca has been committed to becoming a localized multinational pharmaceutical company that "brings in, establishes firmly, and reaches out," leveraging its global resource advantages and deep insights into China's local pharmaceutical market to continuously gather global intellectual resources.

October 23, 2024Day，Eccogene Announces Receipt of $60 Million Milestone Payment from AstraZeneca, Which Will Be Paid Upon Successful Achievement of Development Milestones for ECC5004/AZD5004. In November 2023, AstraZeneca Acquired Global Rights to ECC5004/AZD5004 from Eccogene, for Which Eccogene Received an Upfront Payment of $185 Million and Is Eligible to Receive up to $1.825 Billion in Milestone Payments as Well as Royalties. Eccogene Retains Co-Development and Co-Commercialization Rights for ECC5004/AZD5004 in China.

About Rigerna

Eccogene Bio, a clinical-stage biopharmaceutical company, focuses on metabolic and immune-related diseases. Based on disease biology, medicinal chemistry, and translational medicine, Eccogene Bio has established a novel and differentiated R&D pipeline with a globally leading perspective to address unmet clinical needs in metabolic and immune-related diseases.

October 23, 2024Day，The Drug Clinical Trial Registration and Information Disclosure Platform shows that Shandong Shengdi Pharmaceutical, a subsidiary of Hengrui Pharma, is conducting a Phase II clinical follow-up study (CTR20244009) on HRS-7535 tablets to evaluate the drug's safety, tolerability, and efficacy in obese subjects over the long term. The study received approval from the Medical Ethics Committee of the General Hospital of the People's Liberation Army on August 15 this year.

About HRS-7535

HRS-7535 is an orally administered small molecule GLP-1RA independently developed by Hengrui Pharma. It can activate the GLP-1 receptor, promote insulin secretion and reduce glucagon secretion in the pancreas, inhibit gastric emptying, enhance satiety and suppress appetite through central effects, and directly reduce energy intake through other mechanisms.

About Hengrui Pharma

Hengrui Pharma was founded in 1970 as an international pharmaceutical company engaged in the innovation, development, and promotion of medicines. The company focuses on new drug research and development in areas such as anti-cancer treatments, surgical medications, autoimmune diseases, metabolic disorders, and cardiovascular diseases.

Recently,Suzhou Rigerna Therapeutics Co., Ltd. (referred to as "Rigerna") announced that the Phase 2 clinical trial of RBD1016 injection, independently developed by Rigerna for the treatment of patients with chronic hepatitis B virus (HBV) infection, has received clinical trial approval from the National Medical Products Administration.

RBD1016 is a GalNAc-siRNA drug developed by Rigerna based on its proprietary RIBO-GalSTARTM platform, for which it holds global rights. It targets the X gene of HBV and inhibits all four transcripts of HBV through the RNA interference mechanism, demonstrating the ability to simultaneously suppress HBV DNA replication and reduce cccDNA.A and the ability to integrate DNA-derived HBsAg and other antigens.

About Rigerna

Suzhou Rigerna Therapeutics Co., Ltd. (referred to as "Rigerna") is an innovative R&D company dedicated to developing RNA interference (RNAi) drugs and is a leading pioneer and major player in China's small nucleic acid technology and small nucleic acid pharmaceuticals industry. The company's headquarters is located in Kunshan, Jiangsu, with R&D centers in Beijing and Gothenburg, Sweden.