A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

Start Date01 Oct 2024

Sponsor / Collaborator

Kowa Research Institute, Inc.

NCT06247735 / RecruitingPhase 2

A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study with a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects with Primary Biliary Cholangitis with Inadequate Response to Ursodeoxycholic Acid And/or Obeticholic Acid Treatment

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

Start Date07 Feb 2024

Sponsor / Collaborator

Kowa Research Institute, Inc.

CTIS2022-502643-35-00 / Recruiting

A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12 Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy - K-321-303

Start Date06 Oct 2023

Sponsor / Collaborator

Kowa Research Institute, Inc.

100 Clinical Results associated with Kowa Research Institute, Inc.

0 Patents (Medical) associated with Kowa Research Institute, Inc.

Literatures (Medical) associated with Kowa Research Institute, Inc.

01 Jul 2017·The Lancet HIVQ1 · MEDICINE

Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial

Q1 · MEDICINE

Article

Author: Campbell, Stuart E ; Aberg, Judith A ; Thompson, Melanie A ; Kryzhanovski, Vladimir A ; Ward, Douglas J ; Sponseller, Craig A

BACKGROUNDPeople living with HIV-1 infection are at greater risk for cardiovascular disease than seronegative adults. Treatment of dyslipidaemia with statins has been challenging in people with HIV because of an increased potential for drug interactions due to competing cytochrome P450 metabolism between statins and commonly used antiretroviral agents. Neither pitavastatin nor pravastatin depend on cytochrome P450 for primary metabolism. We aimed to assess the safety and efficacy of pitavastatin versus pravastatin in adults with HIV and dyslipidaemia.METHODSIn the INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs pravastatin for Dyslipidemia) randomised, double-blind, active-controlled, phase 4 trial (INTREPID, we recruited adults aged 18-70 years with controlled HIV (with CD4 counts >200 cells per μL and HIV-1 RNA <200 copies per mL) on antiretroviral therapy for at least 6 months and dyslipidaemia (LDL cholesterol 3·4-5·7 mmol/L and triglycerides ≤4·5 mmol/L) from 45 sites in the USA and Puerto Rico. Patients being treated with darunavir, or who had homozygous familial hypercholesterolaemia or any condition causing secondary dyslipidaemia, or a history of statin intolerance, diabetes, or coronary artery disease were not eligible. We randomly assigned patients (1:1) to pitavastatin 4 mg or pravastatin 40 mg with matching placebos once daily orally for 12 weeks, followed by a 40 week safety extension. Randomisation was stratified by viral hepatitis B or C coinfection and computer-generated. Investigators, patients, study staff, and those assessing outcomes were masked to treatment group. The primary endpoint was percentage change in fasting serum LDL cholesterol from baseline to week 12 and the primary efficacy analysis was done in the modified intention-to-treat population. The safety analysis included all patients who took at least one dose of study medication. This study is registered with ClinicalTrials.gov, number NCT01301066.FINDINGSBetween Feb 23, 2011, and March 29, 2013, we randomly assigned 252 patients to the pitavastatin (n=126) or pravastatin group (n=126). LDL cholesterol reduction was 31·1% with pitavastatin and 20·9% with pravastatin (least squares mean difference -9·8%, 95% CI -13·8 to -5·9; p<0·0001) at 12 weeks. At week 52, four patients (3%) in the pitavastatin group and six (5%) in the pravastatin group had virological failure, with no significant difference between treatments. Both treatments had neutral effects on glucose metabolism parameters. 85 patients treated with pitavastatin (68%) and 88 patients treated with pravastatin (70%) reported treatment-emergent adverse events, and these caused study discontinuation in six patients (5%) versus five patients (4%). No serious adverse event occurred in more than one participant and none were treatment-related according to investigator assessment. The most common treatment-emergent adverse events were diarrhoea in the pitavastatin group (n=12, 10%) and upper respiratory tract infection in the pravastatin group (n=14, 11%). 11 treatment-emergent serious adverse events were noted in seven patients (6%) in the pitavastatin group (atrial septal defect, chronic obstructive pulmonary disease, chest pain, diverticulitis, enterovesical fistula, gastroenteritis, viral gastroenteritis, herpes dermatitis, multiple fractures, respiratory failure, and transient ischaemic attack) and four events in three patients (2%) in the pravastatin group (cerebrovascular accident, arteriosclerosis coronary artery, myocardial infraction, and muscle haemorrhage). In the pravastatin treatment group, one additional patient discontinued due to an adverse event (prostate cancer that was diagnosed during the screening period, 42 days before first dose of study treatment, and therefore was not a treatment-emergent adverse event).INTERPRETATIONThe INTREPID results support guideline recommendations for pitavastatin as a preferred drug in the treatment of dyslipidaemia in people with HIV.FUNDINGKowa Pharmaceuticals America and Eli Lilly and Company.

01 Aug 2014·Clinical TherapeuticsQ4 · MEDICINE

Comparison of the Lipid-Lowering Effects of Pitavastatin 4 mg Versus Pravastatin 40 mg in Adults With Primary Hyperlipidemia or Mixed (Combined) Dyslipidemia: A Phase IV, Prospective, US, Multicenter, Randomized, Double-blind, Superiority Trial

Q4 · MEDICINE

Article

Author: Davidson, Michael H ; Kryzhanovski, Vladimir A ; Morgan, Roger E ; Sponseller, Craig A ; Campbell, Stuart E

PURPOSEResults from a Phase III, European, non-inferiority trial in elderly (age ≥65 years) patients with primary hyperlipidemia or mixed (combined) dyslipidemia demonstrated significantly greater reductions in LDL-C for pitavastatin versus pravastatin across 3 pair-wise dose comparisons (1 mg vs 10 mg, 2 mg vs 20 mg, and 4 mg vs 40 mg, respectively). The present study investigated whether pitavastatin 4 mg is superior to pravastatin 40 mg in LDL-C reduction in adults (18-80 years old) with primary hyperlipidemia or mixed (combined) dyslipidemia.METHODSThis was a Phase IV, multicenter, randomized, double-blind, double-dummy, active-control superiority study conducted in the United States. Patients with baseline LDL-C levels of 130 to 220 mg/dL (inclusive) and triglyceride levels ≤400 mg/dL after a 6-week washout/dietary stabilization period were randomized to 12 weeks of once-daily treatment with either pitavastatin 4 mg or pravastatin 40 mg.FINDINGSA total of 328 subjects (164 per treatment arm) were randomized (mean age, 57.9 years [76% were aged <65 years]; 49.4% women; mean body mass index, 30.2 kg/m(2)) to treatment. The median percent change in LDL-C from baseline to the week 12 endpoint was -38.1% for pitavastatin 4 mg and -26.4% for pravastatin 40 mg; the difference in median percent change between treatments was -12.5% (P < 0.001). Differences between treatments in median percent reductions from baseline for apolipoprotein B, total cholesterol, and non-HDL-C were also significant in favor of pitavastatin (P < 0.001). Both treatments significantly (P < 0.001) increased HDL-C and decreased triglycerides, but the differences between treatments were not statistically significant. The overall rate of treatment-emergent adverse events was 47.6% (78 of 164) for pitavastatin and 44.5% (73 of 164) for pravastatin. Myalgia was reported by 3 patients (1.8%) in the pitavastatin group and by 4 patients (2.4%) in the pravastatin group. There were no reports of myositis or rhabdomyolysis.IMPLICATIONSPitavastatin 4 mg demonstrated superior LDL-C reductions compared with pravastatin 40 mg after 12 weeks of therapy in adults with primary hyperlipidemia or mixed (combined) dyslipidemia. There were no new safety findings in the trial. Clinical Trials.gov identifier: NCT01256476.

01 Jul 2014·Clinical Drug InvestigationQ4 · MEDICINE

Steady-State Pharmacokinetics of Darunavir/Ritonavir and Pitavastatin when Co-administered to Healthy Adult Volunteers

Q4 · MEDICINE

Article

Author: Christine Y. Yu ; David S. Small ; Matthew M. Medlock ; Craig A. Sponseller ; Roger E. Morgan ; Stuart E. Campbell

BACKGROUNDThe treatment of hyperlipidaemia in human immunodeficiency virus (HIV)-infected patients has become increasingly important. However, treatment options are limited because of the drug-drug interaction between certain statins and HIV medications metabolized by cytochrome P450 (CYP) enzymes.OBJECTIVESThe primary objective was to investigate the steady-state pharmacokinetics of pitavastatin when co-administered with darunavir/ritonavir. The secondary objective was to investigate the steady-state pharmacokinetics of both darunavir and ritonavir when co-administered with pitavastatin.METHODSThis was a single-centre, open-label, multi-dose, fixed-sequence study in HIV seronegative healthy volunteers. Pitavastatin 4 mg was administered once daily on days 1-5 and on days 12-16, and darunavir 800 mg/ritonavir 100 mg once daily on days 6-16. Pharmacokinetic blood sampling was performed on days 5, 11 and 16. No significant interaction was concluded if the 90 % confidence intervals (CIs) of the geometric mean ratios (GMRs) for total exposure [i.e. the area under the plasma concentration-time curve over a dosing interval at steady state (AUC(0-τ))] and for peak exposure [i.e. the maximum plasma concentration (C(max))] of the two treatments were within the 80-125 % range.RESULTSTwenty-eight subjects (mean age 30.5 years) were enrolled, and pharmacokinetic data were available for 27 subjects. For pitavastatin, the GMRs and 90 % CIs for the AUC(0-τ) and C(max) ratios with co-administration were 0.74 (0.69-0.80) and 0.96 (0.84-1.09), respectively. For both darunavir and ritonavir, the 90 % CIs for the AUC(0-τ) and C max ratios were within 80-125 % with pitavastatin co-administration. No significant safety issues were reported.CONCLUSIONDarunavir/ritonavir decreased total exposure to pitavastatin by 26 %, while peak exposures were similar. Pitavastatin did not influence the pharmacokinetics of darunavir or ritonavir. There is limited interaction between pitavastatin and darunavir/ritonavir.

News (Medical) associated with Kowa Research Institute, Inc.

15 Jun 2009

·www.biospace.com

Kowa Pharmaceuticals America: Pitavastatin Demonstrates Promise for Low Incidence of Drug-Drug Interaction

Study shows Kowa's novel synthetic statin is safe and well tolerated in combination with warfarin BOSTON, June 15 /PRNewswire/ -- New data presented today showed that pitavastatin may provide a new treatment option for patients with dyslipidemia and complex issues, such as those on multiple medications, as evidenced by a study supporting pitavastatin's potential for low drug-drug interaction. The data were presented today by Kowa at the XV International Symposium on Atherosclerosis in Boston. The study was conducted to evaluate the effect of pitavastatin on warfarin, an anticoagulant often prescribed to patients with cardiovascular disorders. Warfarin has a narrow therapeutic index and is known to have potentially serious interactions with a wide range of medications and food products. The results of the study demonstrated no significant drug-drug interaction between pitavastatin and warfarin. "This study provides compelling evidence that pitavastatin may make cardiovascular risk reduction simpler, especially in more clinically complex patients taking multiple medications," said Roger E. Morgan, M.D., chief medical officer, Kowa Research Institute. "The results presented today suggest pitavastatin may be an effective medication to manage dyslipidemia in these vulnerable populations." An open-label add-on study was conducted to determine the potential for drug interaction following daily administration of pitavastatin 4 mg on the steady-state pharmacodynamic (PD) and pharmacokinetic (PK) profiles of warfarin and to assess the safety and tolerability of coadministration of warfarin and pitavastatin in 24 healthy adult subjects. Once a target INR (measures coagulation of sample blood against a normal measurement) of 1.2 to 2.2 was achieved for each subject with warfarin monotherapy through Day 14, pitavastatin 4 mg was introduced and coadministered with warfarin through Day 21. The results of the study demonstrated that the steady-state PD and PK profiles of warfarin were unaffected by the coadministration of pitavastatin, and thus no significant drug-drug interaction was observed. In addition, pitavastatin 4 mg in combination with warfarin was safe and well tolerated by healthy subjects when compared with warfarin administration alone. "The study shows that pitavastatin may fill an unmet need in the current statin market for patients with dyslipidemia that face complex clinical issues such as potential drug interactions," said Dr. Morgan. "We feel that pitavastatin is a unique and effective medication for this targeted population, and we are looking forward to bringing pitavastatin to the market in the U.S." About pitavastatin Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolemia and combined dyslipidemia. Pitavastatin has a unique cyclopropyl group on the base structure common to the statin class. Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Many of these patients have comorbidities and are taking multiple medications. Kowa has filed a New Drug Application for pitavastatin with the U.S. Food and Drug Administration and expects a response from the agency in Q3 of 2009. Once approved, pitavastatin will be available in the United States in three dosage strengths (1, 2 and 4 mg). About Kowa Company Ltd. and Kowa Pharmaceuticals America, Inc. Kowa Company, Ltd. is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on cardiovascular therapeutics, with fiscal year 2008 sales of the company's flagship product, LIVALO(R) (pitavastatin) totaling $340 million in Japan. Kowa Pharmaceuticals America, Inc. is a specialty pharmaceutical company focused primarily in the area of cardiology. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by Kowa Company, Ltd. in September of 2008. A privately held company, KPA focuses its efforts on the acquisition, development, licensing and marketing of pharmaceutical products. Its lead product, LIPOFEN(R) (fenofibrate capsules), is indicated as adjunctive therapy to diet to reduce elevated triglycerides and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For more information about KPA, please visit CONTACT: Carrie Fernandez, +1-215-238-8500, ext. 1402, cfernandez@voxmedica.com, for Vox Medica, Inc. Web site:

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Drug(Targets)	Indications	Global Highest Phase

Ripasudil Hydrochloride Hydrate ( ROCK )	Ophthalmologic surgical procedures More	Phase 3
K-161	Dry Eye Syndromes More	Phase 3
Pemafibrate ( PPARα )	Nonalcoholic Steatohepatitis More	Phase 2
Tofogliflozin Hydrate ( SGLT2 )	Fibrosis, Liver More	Phase 2
Pemafibrate/Tofogliflozin Hydrate ( PPARα x SGLT2 )	-	Phase 1

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