Delving into the Latest Updates on KD-027 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [1]

Target

PDE5A

Mechanism

PDE5A inhibitors(Phosphodiesterase 5A inhibitors)

Therapeutic Areas

Cardiovascular DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

Erectile DysfunctionHypertensionRaynaud Disease

Originator Organization

Nano Terra, Inc.

Active Organization-

Inactive Organization

Response Pharmaceuticals, Inc.Kadmon Holdings, Inc.

Nano Terra, Inc.

+ [2]

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC25H35N7O6S

InChIKeyKMBGDFWPWSDZTL-UHFFFAOYSA-N

CAS Registry906421-01-0

INTRODUCTIONErectile dysfunction (ED) is a condition that affects millions of men worldwide and is characterized by the inability to achieve or maintain an erection for satisfactory sexual performance. There are numerous treatment options for ED, including medications, mechanical assist devices, and surgical management; however, first-line treatment is usually a phosphodiesterase 5 (PDE5) inhibitor. There is a growing interest in developing novel, efficacious PDE5 inhibitors that provide better quality, safety, and tolerability profiles with less adverse effects. Our review of udenafil, mirodenafil, youkenafil, lodenafil, and SLx-2101 analyzes the safety, efficacy, and pharmacokinetic properties of these new ED drugs.AREAS COVEREDClinical trials demonstrated improved scores in questionnaires, such as the International Index of Erectile Function and Sexual Encounter Profile, for udenafil, mirodenafil, and lodenafil, while youkenafil and SLx-2101 revealed enhanced safety and tolerability in early pharmacokinetic studies.EXPERT OPINIONIt is our opinion that more robust clinical trials are required before these medications can be made available in the United States. Additionally, the field of urology may benefit from pursuing other avenues of pharmacotherapy, such as injections, tablets with a different mechanism of action, or stem cell therapy, to restore the integrity of the endothelium within the penis.

01 Mar 2021·International Journal of HematologyQ4 · MEDICINE

A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China

Q4 · MEDICINE

Article

Author: Tang, En-Tzu ; Liu, Peng ; Hou, Jian ; Du, Juan ; Cai, Zhen ; Shao, Zonghong ; Fang, Baijun ; Wang, Hongxiang ; Niu, Ting ; Li, Jian ; Zou, Dehui ; Xia, Zhongjun ; Wang, Shunqing ; Chen, Wenming ; Fu, Chengcheng ; Jin, Jie ; Hu, Jianda ; Li, Wei ; Kimball, Amy S

The second-generation proteasome inhibitor carfilzomib produces superior outcomes in relapsed or refractory multiple myeloma (MM). We conducted a single-arm trial of twice-weekly carfilzomib (27 mg/m²)-dexamethasone (Kd27) for relapsed and refractory MM in China. Kd27 was administered in 28-day cycles to 123 patients previously treated with ≥ 2 other regimens, including treatment with bortezomib and an immunomodulatory drug, and refractory to their most recent therapy. Overall response rate (ORR) was the primary endpoint; progression-free survival (PFS) and overall survival (OS) were key secondary endpoints. Primary analysis was conducted when all patients received ≥ 6 cycles of Kd27 or discontinued Kd27. Median age was 60 years; median number of prior regimens was 4; 74% were refractory to proteasome inhibitors and immunomodulatory drugs. ORR was 35.8% (95% CI 27.3-44.9), median PFS was 5.6 (95% CI 4.6-6.5) months, and median OS was 16.6 (95% CI 12.2-NE) months. Grade ≥ 3 adverse events (AEs) occurred in 76.4% of patients. Grade ≥ 3 AEs of interest included hypertension (13.8%), acute renal failure (3.3%), cardiac failure (0.8%), ischemic heart disease (0.0%), and peripheral neuropathy (0.0%); 5.7% of patients discontinued carfilzomib due to AEs. Carfilzomib-dexamethasone produced a clinically meaningful response without new safety findings in Chinese patients with previously treated MM.Trial registration: NCT03029234.

02 Jun 2020·Expert Review of HematologyQ4 · MEDICINE

Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States

Q4 · MEDICINE

Article

Author: Dimopoulos, Meletios A. ; Campioni, Marco ; Kumar, Shaji K. ; Panjabi, Sumeet ; Majer, Istvan ; Medhekar, Rohan

BACKGROUNDIn the US, carfilzomib 70 mg⁄m² once-weekly plus dexamethasone (Kd70 QW) was recently indicated for relapsed and/or refractory multiple myeloma. In current US clinical practice, most patients treated with Kd receive carfilzomib at a previously approved dose of 27 mg/m² twice-weekly (Kd27 BIW). This analysis assessed the cost-effectiveness (CE) of Kd70 QW vs Kd27 BIW regimens which were compared in the randomized phase 3 ARROW trial.METHODSBased on clinical outcomes (overall survival and utilities) from ARROW, a partitioned survival model was developed to estimate life years (LYs) and quality-adjusted life years (QALYs). Long-term survival was extrapolated using SEER registry data matched to ARROW patients. Costs were estimated using a US healthcare payer perspective.RESULTSThe analysis estimated that treatment with Kd70 QW vs Kd27 BIW resulted in an increase of 1.10 LYs, 0.91 QALYs, and additional lifetime costs of $74,858, yielding an incremental CE ratio (ratio of incremental costs to QALYs) of $82,257 per QALY gained. Results were robust to sensitivity and subgroup analyses.CONCLUSIONSWhen compared with Kd27 BIW, Kd70 QW is the optimal dose that represents a cost-effective utilization of health care budget with incremental CE ratios well below the accepted willingness-to-pay thresholds in the US.

100 Deals associated with KD-027

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 2	-	Kadmon Holdings, Inc.	-
Hypertension	Phase 2	DE	Kadmon Pharmaceuticals LLC	-
Hypertension	Phase 2	-	Nano Terra, Inc.	-
Hypertension	Phase 2	-	Nano Terra, Inc.	-
Hypertension	Phase 2	DE	Kadmon Pharmaceuticals LLC	-
Hypertension	Phase 2	GB	Kadmon Pharmaceuticals LLC	-
Hypertension	Phase 2	-	Kadmon Holdings, Inc.	-
Raynaud Disease	Phase 2	DE	Surface Logix LLC	-
Hypertension	Discovery	GB	Kadmon Pharmaceuticals LLC	-
Raynaud Disease	Discovery	DE	Surface Logix LLC	-