Elpida (elsulfavirine) / Viriom - LARVOL DELTA

Arginine methylation by protein arginine methyltransferase 1 (PRMT1) affects ADAMTS13 activity (ISTH 2025) - "Results We show that an inhibition of arginine methylation by a PRMTs inhibitor (MS023) in HEK293 cells expressing rADAMTS13 (Fig...Site-directed mutagenesis replacing 5 highly conserved methylation sites (R193, R498, R692, R1123, and R1206) led to identification of the critical role of R1206 in rADAMTS13 function. R1206K variant exhibited a 4~5 fold increased activity, likely resulting from conformational changes that abolished alloteric autoinhibition of ADAMTS13 function. Table or Figure Upload"

Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Ischemic stroke • Mood Disorders • Novel Coronavirus Disease • Thrombocytopenic Purpura • PRMT1

A Unique Model for Accelerating Drug Development and Clinical Trials towards Drug Approvals in Rare Pediatric CNS disorders (ASGCT 2025) - "Our lead clinical-stage program for SPG50 disease has progressed through clinical phases in half the time of traditional pipelines, and our lead product MELPIDA currently at Phase 3 trials. Our strategy at Elpida Therapeutics exemplifies a novel and highly effective approach to drug development in rare CNS disorders where there is a limited patient population and a significant unmet medical need. This model not only promises to shorten timelines but also aims to make the drug development process more patient-centric, cost-effective, and scalable for the future of precision medicine in rare diseases."

Clinical • Late-breaking abstract • CNS Disorders • Pediatrics • Rare Diseases

Arginine Methylation by PRMT1 Affects ADAMTS13 Secretion and Enzymatic Activity. (PubMed, Arterioscler Thromb Vasc Biol) - "An inhibition of arginine methylation by a PRMT inhibitor (a type I methyl transferase inhibitor, MS023) in human embryonic kidney 293 cells expressing recombinant ADAMTS13 and mice results in a significant reduction of ADAMTS13 secretion, but the secreted ADAMTS13 shows an increased specific activity; conversely, overexpression of PRMT1 in human embryonic kidney 293 cells and mice results in an increase of ADAMTS13 secretion, but the secreted ADAMTS13 exhibits a significantly reduced proteolytic activity...Site-directed mutagenesis of 5 highly conserved methylation sites (R193, R498, R692, R1123, and R1206) identifies the critical role of R1206 in ADAMTS13 function...These results demonstrate the crucial role of arginine methylation on ADAMTS13 secretion and activity. Our findings may shed new light on the mechanism of allosteric regulation of ADAMTS13, which may have a therapeutic implication."

Journal • Cardiovascular • Hematological Disorders • Thrombocytopenic Purpura • Thrombosis • PRMT1

Current status of the small molecule anti-HIV drugs in the pipeline or recently approved. (PubMed, Bioorg Med Chem) - "These compounds include analogues of nucleoside reverse transcriptase inhibitors (NRTIs) - islatravir and censavudine; non-nucleoside reverse transcriptase inhibitors (NNRTIs) - Rilpivirine, elsulfavirine and doravirine; integrase inhibitors namely cabotegravir and dolutegravir and chemokine coreceptors 5 and 2 (CC5/CCR2) antagonists for example cenicriviroc. Also, fostemsavir is being developed as an attachment inhibitor while lenacapavir, VH4004280 and VH4011499 are capsid inhibitors. Others are maturation inhibitors such as GSK-254, GSK3532795, GSK3739937, GSK2838232, and other compounds labelled as miscellaneous (do not belong to the classical groups of anti-HIV drugs or to the newer classes) such as obefazimod and BIT225. There is a considerable progress in the development of new anti-HIV drugs and the effort will continue since HIV infections has no cure or vaccine till now. Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new..."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • CCR2

From Review to Readiness: CMT4J and the Road to Clinical Trials (ASGCT 2024) - "Furthering this partnership, Elpida Therapeutics will conduct a prospective, observational natural history study aimed at characterizing CMT4J's clinical and genetic spectrum.In this study, 20 individuals will be recruited across four specialized medical centers...These include clinical and neurological exams, laboratory tests to investigate potential biomarkers, CMT-specific outcome measures, neuropsychological tests, nerve conduction studies, muscle fat fraction as measured by MRI, pulmonary function tests, and scoliosis series x-rays. These assessments will provide invaluable insights into the disease course, inform future therapeutic strategies, and enhance readiness for clinical trials in this rare neurodegenerative disorder."

Clinical • Review • CNS Disorders • Gene Therapies • Genetic Disorders • Movement Disorders • Pain • Parkinson's Disease

INDUSTRY SYMPOSIUM (NO CME/CPD CREDIT): State-of-the-art of treatment and diagnosis of alpha-synuclein pathologies (ADPD 2024) - "Elpida Tsika who will focus on the development of Morphomer a-syn small molecule drugs, and Dr. Nuno Mendonça who will present an update from AC Immune's active immunotherapy targeting alpha-synuclein, ACI-7104.056, which is being evaluated in the Phase 2 clinical trial VacSYn. The session concludes with an interactive Q&A, providing attendees with the opportunity to engage directly with the speakers. Join us for a scientifically grounded exploration into the evolving landscape of treatments and diagnosis for alpha-synuclein pathologies."

CNS Disorders • Movement Disorders • Parkinson's Disease

ROME: Remotely Observed Methadone Evaluation (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: Sonara Health

New trial • Substance Abuse

Current insights and molecular docking studies of HIV-1 reverse transcriptase inhibitors. (PubMed, Chem Biol Drug Des) - "Zidovudine, didanosine, and stavudine are FDA-approved NRTIs, while nevirapine, efavirenz, and delavirdine are FDA-approved NNRTIs. Several agents are in clinical trials, including apricitabine, racivir, elvucitabine, doravirine, dapivirine, and elsulfavirine. This review addresses HIV-1 structure, replication cycle, reverse transcription, and HIV drug targets. This study focuses on NRTIs and NNRTIs, their binding sites, mechanisms of action, FDA-approved drugs and drugs in clinical trials, their resistance and adverse effects, their molecular docking studies, and highly active antiretroviral therapy (HAART)."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Nitrogen Application Can Be Reduced without Affecting Carotenoid Content, Maturation, Shelf Life and Yield of Greenhouse Tomatoes. (PubMed, Plants (Basel)) - "Tomatoes (Solanum lycopersicum L.) of the variety Elpida were grown under standard Mediterranean greenhouse conditions during the spring season at three different nitrogen levels (low 6.4, standard 12.8, high 25.9 mM/plant), which were replicated during two consecutive years...The colour indices L* and a* and the hue angle (a/b*) were positively correlated with the sum of total carotenoids, while differences in b* depended on the year of cultivation. The sustainability of this type of tomato production can be improved by reducing the nitrogen supply to less than the current standard practice, with minimal risk or negative effects on yield and quality of tomatoes."

Journal

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Viriom | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

"Thanks Elpida🥰" (@S_Gharibzadeh)

"Thanks Elpida" (@YoginiChudasama)

Approved HIV reverse transcriptase inhibitors in the past decade. (PubMed, Acta Pharm Sin B) - "Here, we provide a comprehensive review of RT inhibitors (tenofovir alafenamide, rilpivirine, doravirine, dapivirine, azvudine and elsulfavirine) approved in the past decade, regarding their drug discovery, pharmacology, and clinical efficacy in randomized controlled trials. Novel RT inhibitors such as islatravir, MK-8504, MK-8507, MK8583, IQP-0528, and MIV-150 will be also highlighted. Future development may focus on the new generation of novel antiretroviral inhibitors with higher bioavailability, longer elimination half-life, more favorable side-effect profiles, fewer drug-drug interactions, and higher activities against circulating drug-resistant strains."

Journal • Review • Human Immunodeficiency Virus • Immunology • Infectious Disease

"Congratulations Elpida!" (@RuthJMatthews)

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Viriom | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2022 ➔ Jun 2022

Enrollment open • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

"Congrats Elpida! 🎉" (@YoginiChudasama)

"Many congratulations Elpida! 😁" (@SamuelJTromans)

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: Viriom; Not yet recruiting ➔ Completed; N=42 ➔ 56

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease

Study to Evaluate Efficacy and Safety of Switching to VM-1500A-LAI + 2NRTIs From the 1st Line Standard of Care Therapy (clinicaltrials.gov) - P2/3; N=438; Not yet recruiting; Sponsor: Viriom

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Viriom

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Hikma Pharmaceuticals LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Viriom; Recruiting ➔ Completed

Clinical • Trial completion • Hepatology • Human Immunodeficiency Virus • Infectious Disease

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Viriom

Clinical • New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA® (clinicaltrials.gov) - P1/2; N=36; Completed; Sponsor: Viriom

Clinical • New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: Viriom; Not yet recruiting ➔ Completed; N=42 ➔ 27

Clinical • Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease