Article
Endocrinology & Metabolism
Wonjung Shin, Marcus Hompesch, JinHee Byeon, Seohyun Kang, Jaehyuk Choi, Seungjae Baek
Summary: This study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of a novel long-acting glucagon analogue HM15136 in overweight/obese patients with co-morbidities, with and without type 2 diabetes (T2D). The results showed that HM15136 had good safety and tolerability in patients with dyslipidaemia and/or hypertension, but its use in patients with T2D may cause hyperglycaemia.
DIABETES OBESITY & METABOLISM
(2023)
Article
Pharmacology & Pharmacy
Xue Zhao, Hongzhong Liu, Wei Tian, Ligang Fang, Mengyang Yu, Xiaofei Wu, Aijing Liu, Ruijie Wan, Li Li, Jinghui Luo, Yuqiong Li, Bo Liu, Yu He, Xiaowen Chen, Yuan Li, Donghong Xu, Hongyun Wang, Xiaohong Han
Summary: This study aimed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of aficamten in healthy Chinese adults. The results showed that aficamten was safe and well-tolerated in the Chinese population, with pharmacokinetics comparable to Western participants. These findings support future clinical studies of aficamten in Chinese patients.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Chemistry, Medicinal
Xuemei He, Xin Gao, Panpan Xie, Yuan Liu, Wenjing Bai, Yue Liu, Aixin Shi
Summary: This study assessed the pharmacokinetic and pharmacodynamic profiles, safety, and tolerability of sotagliflozin in Chinese healthy subjects. The results showed that sotagliflozin was rapidly absorbed with dose-proportional systemic exposure and a moderate degree of accumulation. Both 200mg and 400mg doses of sotagliflozin per day were well tolerated in Chinese healthy subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2022)
Article
Medicine, General & Internal
Pieter Sonneveld, Meletios A. Dimopoulos, Mario Boccadoro, Hang Quach, P. Joy Ho, Meral Beksac, Cyrille Hulin, Elisabetta Antonioli, Xavier Leleu, Silvia Mangiacavalli, Aurore Perrot, Michele Cavo, Angelo Belotti, Annemiek Broijl, Francesca Gay, Roberto Mina, Inger S. Nijhof, Niels W. C. J. van de Donk, Eirini Katodritou, Fredrik Schjesvold, Anna Sureda Balari, Laura Rosinol, Michel Delforge, Wilfried Roeloffzen, Tobias Silzle, Annette Vangsted, Hermann Einsele, Andrew Spencer, Roman Hajek, Artur Jurczyszyn, Sarah Lonergan, Tahamtan Ahmadi, Yanfang Liu, Jianping Wang, Diego Vieyra, Emilie M. J. van Brummelen, Veronique Vanquickelberghe, Anna Sitthi-Amorn, Carla J. de Boer, Robin Carson, Paula Rodriguez-Otero, Joan Blade, Philippe Moreau
Summary: The addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy showed significant improvement in progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Endocrinology & Metabolism
Ki Young Huh, Jun Gi Hwang, Wonjung Shin, Seungjae Baek, JaeDuk Choi, Nora Lee, Young Min Cho, Howard Lee
Summary: HM15136, a novel long-acting glucagon analogue, was shown to be safe and well tolerated in doses ranging from 10-120 μg/kg in a randomized, double-blind, placebo-controlled study. It increased blood glucose levels and suppressed the secretion of endogenous glucagon.
DIABETES OBESITY & METABOLISM
(2022)
Article
Pharmacology & Pharmacy
Dominic Beale, Jeremy Dennison, Malcolm Boyce, Francesca Mazzo, Naoki Honda, Paul Smith, Mark Bruce
Summary: The study demonstrated that ONO-7684 was well-tolerated in healthy subjects at both single and multiple doses, with low incidence of adverse events. Pharmacokinetic data showed dose proportionality for ONO-7684. Pharmacodynamic results revealed a strong inhibition of FXI coagulation activity and an increase in aPTT at 250 mg ONO-7684 daily. These findings support the potential of ONO-7684 as an oral FXIa inhibitor for anticoagulation indications.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Article
Medicine, General & Internal
Jesus San-Miguel, Binod Dhakal, Kwee Yong, Andrew Spencer, Sebastien Anguille, Maria-Victoria Mateos, Carlos Fernandez de Larrea, Joaquin Martinez-Lopez, Philippe Moreau, Cyrille Touzeau, Xavier Leleu, Irit Avivi, Michele Cavo, Tadao Ishida, Seok Jin Kim, Wilfried Roeloffzen, Niels W. C. J. van de Donk, Dominik Dytfeld, Surbhi Sidana, Luciano J. Costa, Albert Oriol, Rakesh Popat, Abdullah M. Khan, Yael C. Cohen, P. Joy Ho, James Griffin, Nikoletta Lendvai, Carolina Lonardi, Ana Slaughter, Jordan M. Schecter, Carolyn C. Jackson, Kaitlyn Connors, Katherine Li, Enrique Zudaire, Diana Chen, Jane Gilbert, T. Yeh, Sarah Nagle, Erika Florendo, Lida Pacaud, Nitin Patel, Simon J. Harrison, Hermann Einsele
Summary: In patients with lenalidomide-refractory multiple myeloma, Ciltacabtagene autoleucel (CAR-T cell therapy) showed a lower risk of disease progression or death compared to standard care, highlighting its effectiveness in this patient population.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Biotechnology & Applied Microbiology
Li Du, Wei Liu, Flavia Pichiorri, Steven T. Rosen
Summary: This study identified SUMOylation as a potential mechanism regulating lenalidomide resistance in multiple myeloma. Inhibition of SUMOylation can enhance sensitivity to lenalidomide by downregulating IRF4 expression.
CANCER GENE THERAPY
(2023)
Article
Chemistry, Medicinal
Inseung Jeon, Jaeseong Oh, Yu-Kyung Kwon, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu, SeungHwan Lee
Summary: The study compared the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of the reference drug in healthy subjects. Results showed that CKD-11101 was well tolerated and exhibited comparable PK and PD characteristics with the reference drug after a single intravenous (IV) or subcutaneous (SC) dose.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Review
Oncology
Felipe de Arriba de la Fuente, Carmen Montes Gaisan, Javier de la Rubia Comos
Summary: Lenalidomide is a key drug for the treatment of multiple myeloma, but excessive use has led to treatment resistance. This review summarizes the current treatment options and discusses potential future therapies. While lenalidomide-based combinations can improve the response rate and survival of multiple myeloma patients, the strategy of using them as a frontline treatment has resulted in early development of resistance. Therefore, there is a need for other treatment options.
Article
Pharmacology & Pharmacy
Hao Cai, Satoko Kakiuchi-Kiyota, Robert Hendricks, Shelly Zhong, Luna Liu, Adeyemi O. Adedeji, Pamela Chan, Melissa M. Schutten, Amrita Kamath, Meric A. Ovacik
Summary: This study characterized the nonclinical PK, PD, sBCMA, and sCD16 changes following administration of RO7297089, developed a TMDD model, and used simulations to inform clinical dose regimens.
Article
Chemistry, Medicinal
Hyewon Chung, Jin-Woo Park, Dai-Hyun Kim, Soo-Hong Seo, Kyoung-Ah Kim, Woo-Shun Lee, Ji-Young Park
Summary: This study investigated the pharmacokinetics, pharmacodynamics, and safety/tolerability of MT921, an injectable cholic acid, in healthy volunteers after a single subcutaneous administration. The results showed that systemic exposure to cholic acid increased with dose escalation, while blood lipid profiles and deoxycholic acid levels were unaffected by MT921 treatment. Adverse events such as injection site pain and edema were mild and resolved without treatment.
Article
Pharmacology & Pharmacy
Engie Salama, Stepfanie Lam, Wilson Gonsalves, Dimitrios Tzachanis, Jeremiah D. Momper, Ila M. Saunders
Summary: This study evaluated the impact of different equations used to estimate kidney function on lenalidomide dosing in newly diagnosed multiple myeloma patients. It found that using MDRD or CKD-EPI instead of CG(ABW) could potentially lead to a significant proportion of patients receiving discordant doses. Therefore, physicians should use CG(ABW) to estimate renal function for dosing lenalidomide.
ANNALS OF PHARMACOTHERAPY
(2023)
Review
Chemistry, Multidisciplinary
Kris Dammen-Brower, Paige Epler, Stanley Zhu, Zachary J. Bernstein, Paul R. Stabach, Demetrios T. Braddock, Jamie B. Spangler, Kevin J. Yarema
Summary: This article discusses the important role of glycosylation in therapeutic proteins and provides examples of drugs that have been improved through glycoengineering. As glycoengineering strategies develop, deliberate modification of therapeutic protein glycosylation will become more prevalent.
FRONTIERS IN CHEMISTRY
(2022)
Article
Pharmacology & Pharmacy
Luc Bergougnan, Sara Armani, Georg Golor, Agnes Tardat, Olivier Vitse, Fabrice Hurbin, Michel Scemama, Franck Poitiers, David Radzik, Christophe Gaudin, Lionel Hovsepian, Anthony J. Muslin, Stephane Kirkesseli, Paul Deutsch, Ashfaq A. Parkar
Summary: SAR247799 is a selective G-protein-biased sphingosine-1 phosphate receptor-1 agonist that has the potential to restore endothelial function in vascular pathologies without causing receptor desensitization. This first-in-class molecule demonstrated good tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Correction
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
CLINICAL DRUG INVESTIGATION
(2020)
Review
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
Article
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)
Article
Pharmacology & Pharmacy
Esther S. Kim, Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)
Correction
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
Article
Pharmacology & Pharmacy
Caroline Fenton, Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)
Correction
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)
Correction
Pharmacology & Pharmacy
Emma H. McCafferty, Katherine Ann Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Article
Pharmacology & Pharmacy
Kate McKeage, Katherine Ann Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Article
Pharmacology & Pharmacy
Emma D. Deeks, Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Correction
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Article
Pharmacology & Pharmacy
Hannah A. Blair, Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Article
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2019)
Article
Pharmacology & Pharmacy
Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)
Article
Pharmacology & Pharmacy
Esther S. Kim Bullet, Katherine A. Lyseng-Williamson
DRUGS & THERAPY PERSPECTIVES
(2020)