CaPre (omega-3 phospholipid) / Grace Therapeutics - LARVOL DELTA

Effectiveness of a Novel ω-3 Krill Oil Agent in Patients With Severe Hypertriglyceridemia: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P3 | "To determine the phase 3 efficacy and safety of a naturally derived krill oil with eicosapentaenoic acid and docosahexaenoic acid as both phospholipid esters (PLs) and free fatty acids (FFAs) (ω-3-PL/FFA [CaPre]), measured by fasting TG levels and other lipid parameters in severe hypertriglyceridemia...This study found that ω-3 -PL/FFA, a novel krill oil-derived ω-3 formulation, reduced TG levels and was safe and well tolerated in patients with severe hypertriglyceridemia. ClinicalTrials.gov Identifiers: NCT03398005 and NCT03361501."

Clinical • Journal • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Treatment of Hypertriglyceridemia: A Review of Therapies in the Pipeline. (PubMed, J Pharm Pract) - " Currently, the only US Food and Drug Administration approved medication for CV risk reduction in patients with hypertriglyceridemia is icosapent ethyl. Results from phase 3 trials for CaPre, pemafibrate, and volanesorsen as well as additional evidence for pipeline pharmacotherapies with novel mechanisms of action (e.g., ApoC-III mRNA antisense inhibitors and ANGPTL3 antibodies) will help to guide future pharmacotherapy considerations for patients with hypertriglyceridemia."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Hypertriglyceridemia • PPARA

"Sai quanti "lavoratori" della supply-chain ho incontrato che sono ignoranti come capre? Pronto a difendere la tua categoria? D'altronde l'efficienza delle aziende italiane è rinomata in tutto il mondo." (@LucaMarini70)

A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2) (clinicaltrials.gov) - P3; N=278; Completed; Sponsor: Acasti Pharma Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertriglyceridemia

Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: AstraZeneca; N=30 -> 40

Enrollment change • Biosimilar • Oncology • Thyroid Cancer

Combined Analysis of the Prevalence of drug Resistant HBV in antiviral therapy Experienced patients in Europe (CAPRE). (PubMed) - " These findings support resistance testing in cases of apparent NA therapy failure. This survey highlights the impact of exposure to lamivudine and adefovir on development of drug resistance and cross-resistance. Continued use of these NAs needs to be reconsidered at a pan-European level."

Journal • Biosimilar • Immunology • Inflammation

Brief Bactericidal Activity of Anti-Tuberculosis Drugs (clinicaltrials.gov) - P=N/A; N=150; Not yet recruiting; Sponsor: Centers for Disease Control and Prevention

New trial • Biosimilar

Effect of pre-treatment of bentonite with sodium and calcium ions on phosphate adsorption onto zirconium-modified bentonite. (PubMed, J Environ Manage) - "The increased phosphate adsorption capacity for zirconium-modified bentonite induced by the Capre-treatment could be mainly due to the increase in the amount of exchangeable Ca. Results of this work suggest that the zirconium-modified Ca-pretreated bentonite is more suitably used as an adsorbent for the removal of phosphate from wastewater than the zirconium-modified raw and Na-pretreated bentonites."

Journal • Biosimilar

Fatty Acid Metabolism in Carriers of Apolipoprotein E Epsilon 4 Allele: Determining the Blood-to-brain Link (clinicaltrials.gov) - P=N/A; N=160; Not yet recruiting; Sponsor: Université de Sherbrooke

New trial • APOE

"$ACST CC tomorrow at 1 pm ET to discuss Q3 as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre." (@BioStocks)

P3 data

Acasti Pharma reports third quarter FY 2018 financial results (GlobeNewswire) - "Acasti achieved several goals in the third quarter including closing a successful $13.6 million financing that supports the initiation of our CaPre Phase 3 clinical program...expect to continue advancing...for the treatment of severe hypertriglyceridemia through the patient enrollment process in 2018, and beyond to expected top line results by the end of 2019...entered into a non-binding term sheet agreement this quarter with a leading Chinese pharmaceutical company for the development and commercialization of CaPre in certain Asian countries."

Enrollment status • Licensing / partnership • P3 data: top line

A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1) (clinicaltrials.gov) - P3; N=256; Completed; Sponsor: Acasti Pharma Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

"https://t.co/Lom01gZf8t @DLBHATTMD @EverlastDD understanding the DD becomes imperative. Blind followers of krill CaPre failed to understand the results as noted herein. $AMRN and $MTNB are for now the most alluring CVD reducers. #Cardiology #HeartNews" (@LovingGeneva)

"CaPre is the triglyceride version of Epanova. So (with DHA) CaPre will fail any CVOT as well. Same fail but at a higher cost to manufacture (as compared to EE products)." (@Trumps_Bastard)

"$ACST 36.7% median reduction in triglyceride levels among patients receiving CaPre, compared to a 28.0% median reduction in triglyceride levels among patients receiving placebo. 😬 $AMRN" (@BioStocks)

Clinical

"$ACST (off 24% yesterday) delays Trilogy-1 readout, so both CaPre studies should now yield data in Jan 2020. Background --> https://t.co/9mPjaZFPVl $AMRN" (@JacobPlieth)

"CaPre baby! $ACST :)" (@ATLanalyst)

"Acasti's CaPre, Matinas' MAT9001, Astrazeneca's Epanova, Lovaza, Omacor, Omtryg, Vascepa. All purified omega-3 products. Differences in type/mix of omega-3 ( EPA/DHA/DPA) & chemical form. Jury still out on EPA-specific effects. At same dose, all similar? https://t.co/iKCeZN796c" (@BearDownAZ_2019)

A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2) (clinicaltrials.gov) - P3; N=245; Active, not recruiting; Sponsor: Acasti Pharma Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2019 ➔ Nov 2019; Trial primary completion date: Apr 2019 ➔ Aug 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1) (clinicaltrials.gov) - P3; N=245; Active, not recruiting; Sponsor: Acasti Pharma Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2019 ➔ Nov 2019; Trial primary completion date: Apr 2019 ➔ Jul 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date