Tides Weekly | Global Peptide and Oligonucleotide Therapeutics News Roundup
AusperBio
Biological Vaccine and Nucleic Acid Drug Developer
Recently, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Tonghua Dongbao Pharmaceutical Co., Ltd. has initiated a randomized, double-blind, placebo-controlled Phase Ib trial (CTR20242389) for THDBH120. The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of multiple doses of THDBH120 in Chinese obese subjects.
THDBH120 is a dual-target agonist of glucagon-like peptide-1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor. It integrates the insulinotropic effects of both GLP-1 and GIP into a single peptide molecule. Further molecular design enhances metabolic stability, improves blood glucose control, and meets the clinical needs of diabetic patients who respond poorly to single-target molecules or combination therapies. THDBH120 is expected to become a long-acting blockbuster drug for diabetes treatment.
AboutTongTonghua Dongbao Pharmaceutical Co., Ltd.
Tonghua Dongbao Pharmaceutical Co., Ltd. (Abbreviation: Tonghua Dongbao, Stock Code: 600867.SH) is a renowned pharmaceutical company in China that integrates drug research and development, production, and sales. The company has a deep focus on the diabetes treatment field and possesses the most comprehensive and diverse pipeline of diabetes treatment product research and development in the industry.
July 6, 2024DayAusperBio (Ausper Biopharma Co., Ltd. and AusperBio Therapeutics, Inc.), a clinical-stage biopharmaceutical company dedicated to advancing targeted oligonucleotide therapies and leading innovation in hepatitis B cure, today announced significant progress in the clinical development of its leading innovative drug AHB-137 under the Med-Oligo™ technology platform. As an unconjugated antisense oligonucleotide (ASO) innovative drug, AHB-137 specifically targets all HBV mRNAs and has great potential to become a cornerstone drug in future combination therapies for curing hepatitis B.
About AHB-137
AHB-137 is a non-conjugated antisense oligonucleotide (ASO) with the potential to become a cornerstone for functional cure of chronic hepatitis B. It is the first innovative drug from AusperBio's self-developed platform Med-Oligo™ to enter clinical trials, and its excellent preclinical data gained widespread attention at the 2023 EASL™ conference. Currently, AHB-137 is concurrently undergoing a Phase I international multicenter clinical trial.And a Phase II clinical trial conducted in China. Through global strategic planning, accelerate the goal of achieving functional cure for hepatitis B.
About AusperBio
AusperBio, a clinical-stage innovative drug development company operating simultaneously in China and the United States, is committed to developing First-in-class and Best-in-class proprietary targeted delivery small nucleic acid drugs. AusperBio owns the proprietary Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases, while expanding its research into targeted small nucleic acid therapies for new targets beyond the liver.
July 8, 2024DayInnorna, a clinical-stage biopharmaceutical company focusing on lipid nanoparticle (LNP) delivery technology and the development of innovative RNA therapies, announced that the U.S. FDA has granted Rare Pediatric Disease Designation (RPDD) to its investigational new drug IN022. IN022 is used for the treatment of Homocystinuria (HCU), a life-threatening inherited metabolic disorder. The RPDD will significantly accelerate the clinical development of IN022, benefiting patients as soon as possible. Receiving RPDD also means that the FDA may grant Innorna a priority review voucher after the approval of the IN022 product.
About Homocystinuria and IN022
Homocystinuria (HCU) is a rare autosomal recessive inherited metabolic disorder caused by a defect in cystathionine β-synthase (CBS). The disease typically manifests after the age of three and primarily causes multisystemic damage, including neuropsychiatric, cerebrovascular, and cardiovascular impairments, presenting symptoms such as intellectual disability, vision loss, lens dislocation, skeletal abnormalities, and thrombotic risks.Risk escalation, etc.
About DeepTrust Bio
DeepTrust Bio was founded in 2019 and is dedicated to developing a world-leading LNP delivery technology platform and innovative RNA therapies to address unmet clinical needs. DeepTrust Bio has established a Diversity-Oriented LNP Library (DOLL) containing more than 5,000 ionizable lipids, which can be applied to the development of various innovative therapies, including mRNA vaccines and drugs, in vivo gene editing therapies, and cell therapies.
On July 9, 2024, Suzhou Sine Pharmaceutical Co., Ltd. ("Sine Pharma") announced that the clinical trial application for SGB-3908 Injection, a small nucleic acid (siRNA) drug for the treatment of hypertension jointly developed with Innovent Biologics, has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (application number: CXHL2400426). This marks the third siRNA drug for which Sine Pharma has applied to conduct clinical trials in China, following SGB-3403 Injection and SGB-9768 Injection.
SGB-3908 is an siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical trial data show that SGB-3908 significantly reduces AGT protein and related biomarkers (ANG I, ANG II) in the serum of hypertensive cynomolgus monkeys, achieving a marked blood pressure-lowering effect with long-lasting results, and no adverse effects observed.Observed safety issues such as hypotension. SGB-3908 utilizes AusperBio's uniquely innovative next-generation siRNA drug platform technology, which enhances the drug's superior activity and prolonged efficacy while demonstrating good safety and tolerability.
AboutHolyBiological
SaintRNA was founded in early 2021 as a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology, with research and development centers in both China and the United States. The founding team consists of senior experts in the field of nucleic acid drugs, possessing years of experience in nucleic acid drug development and cutting-edge technical expertise in the industry.
July 10, 2024Day, according toCenter for Drug Evaluation (CDE) of the National Medical Products AdministrationPublic Notice, Shiyao Group ResearchAusperBio's Respiratory Syncytial Virus mRNA Vaccine Receives Clinical Trial Implied Permission for the Prevention of Lower Respiratory Tract Diseases Caused by Respiratory Syncytial Virus Infection, Becoming the Third Approved RSV mRNA Vaccine to Enter Clinical Trials.
Currently, no RSV vaccines have been approved for marketing in China. The two RSV vaccines available globally are both recombinant protein subunit vaccines. In China, three RSV vaccine clinical trial applications based on the mRNA technology pathway have been accepted by the CDE and have all been approved to proceed with clinical trials.
About CSPC
CSPC Holding Group Co., Ltd. was established in 1997. Through global innovation efforts, CSPC continuously delivers better innovative outcomes for human health. The group has built a diversified product portfolio, focusing on three major sectors: finished drugs, active pharmaceutical ingredients (APIs), and functional foods. Additionally, it has actively contributed to the prevention and treatment of the coronavirus. The group’s mRNA COVID-19 vaccine is China's first self-developed vaccine to receive emergency use authorization, with two other novel global therapeutic drugs approved for clinical trials.
July 10, 2024DayAmylyx Pharmaceuticals announced the acquisition of Eiger BioPharmaceuticals' investigational therapy Avexitide. Avexitide has been studied to date for the treatment of hyperinsulinemic hypoglycemia. Amylyx anticipates initiating a Phase 3 clinical trial in the first quarter of 2025 to evaluate the efficacy of avexitide in treating post-bariatric hypoglycemia (PBH).
Avexitide is a potential "first-in-class" glucagon-like peptide-1 (GLP-1) receptor antagonist, which has been evaluated in five clinical trials for the treatment of postoperative hypoglycemia and is also being used in clinical trials to treat congenital hyperinsulinism (HI). Both indications are characterized by hyperinsulinemic hypoglycemia. The U.S. FDA has granted avExitide has received Breakthrough Therapy Designation for the treatment of these two indications.
Avexitide is designed to bind to GLP-1 receptors on pancreatic β-cells, blocking the action of GLP-1 by reducing insulin secretion and stabilizing glucose levels to alleviate hypoglycemia.In PBH, an excess of GLP-1 can lead to hyperinsulinemia and subsequent severe hypoglycemic events, including autonomic and neuroglycopenic symptoms.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, founded in 2013, is a pharmaceutical company headquartered in Cambridge, Massachusetts, dedicated to developing potential therapies for neurodegenerative diseases.
July 11, 2024On [Date], Innorna, a clinical-stage biopharmaceutical company focused on lipid nanoparticle (LNP) delivery technology and the development of innovative RNA therapies, announced that the U.S. FDA has granted Rare Pediatric Disease Designation (RPDD) to its investigational mRNA new drug IN016.
July 11, 2024DayPfizer announced that, based on the results of the ongoing pharmacokinetic study (NCT06153758), it has identified a preferred extended-release formulation for the oral GLP-1R agonist Danuglipron (PF-06882961) with once-daily dosing. In addition, Pfizer plans to initiate a dose optimization study of this extended-release formulation in the second half of 2024 to evaluate the efficacy and safety of multiple doses, providing a reference for registrational studies.
This study is a randomized, open-label clinical trial designed to evaluate the pharmacokinetics and safety of Danuglipron oral immediate-release and oral extended-release formulations in healthy adults. The results indicate that the new formulation allows for once-daily dosing of Danuglipron. Its safety profile is consistent with previous studies, with no observed elevation in liver enzymes.
Previously, Danuglipron was administered twice daily. In December last year, DanuglIpron (Twice Daily) Phase IIb Study in Obese Adult Patients Without Type 2 Diabetes Meets Primary Endpoint
About Danuglipron
DanugLipron (PF-06882961) is an experimental drug administered orally in tablet form and has not yet been approved by health authorities. Danuglipron, discovered and developed in-house by Pfizer, is a small-molecule oral GLP-1R drug.
About Pfizer
Pfizer Inc. was founded in 1849, with its headquarters located in New York, USA. It is a science-based, innovative, patient-first biopharmaceutical company.