|Over a week ago|
Hepion Pharmaceuticals receives DSMB approval to continue AMBITION trial » 07:3512/2912/29/20
Hepion Pharmaceuticals announced that an independent Data Safety Monitoring Board, or DSMB, has approved the continuation of the company's Phase 2a AMBITION clinical trial. Two interim analyses were performed by a DSMB to evaluate the safety and tolerability of the 75 mg CRV431 dose cohort in NASH patients. The first analysis occurred half-way through the first dosing cohort and this, the second analysis, occurred at the completion of the first dosing cohort. Hepion's novel drug candidate, CRV431, is a pan-cyclophilin inhibitor that inhibits multiple forms of cyclophilins. Cyclophilins, of which there are 17 known isoforms in humans, play a central role in protein folding and contribute to numerous biological effects including inflammation and fibrosis. The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. In this study, which is being conducted at 10 U.S. sites, CRV431 is administered orally, once-daily for 28 days. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. The secondary outcome measure of this Phase 2a trial is to evaluate decreases in non-invasive antifibrotic markers from baseline to the end of the study. Data from the AMBITION trial will be used alongside Hepion's proprietary AI-POWRTM to guide and enrich future study design.
|Over a month ago|
Hepion announces FDA clearance of IND application for CRV431 for Covid » 07:3812/2212/22/20
Hepion Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted its investigational new drug application for CRV431, a novel cyclophilin inhibitor for the treatment of COVID-19. On July 7, Hepion announced a potential two-pronged strategy to treat COVID-19. First, preclinical cell culture experiments demonstrated CRV431 decreased SARS-CoV-1 production of infectious virus. Second, in a non-viral, acute lung injury model, CRV431 demonstrated attenuated lung inflammation and damage similar to or better than dexamethasone, including reductions in neutrophils and IL-6. This property may be beneficial to patients suffering longer term consequences of COVID-19 infection, including acute respiratory distress syndrome . Importantly, COVID-19 patients developing ARDS have a higher mortality rate.1 Taken together, this dual mode of action suggested that CRV431 may offer an opportunity to treat both the viral infection as well as lung injury in COVID-19. "The recent identification of a mutational variant of SARS-CoV-2 that is potentially more infectious than previous strains is a reminder that we must continue to battle this virus on all fronts. Host cyclophilins play a key role in the propagation of viruses. CRV431, a cyclophilin inhibitor, interrupts the ability of the virus to use these human cyclophilins and thereby reduces viral propagation. As such, CRV431 is likely less prone to treatment resistance that may be seen when viral mutations occur," stated Dr. Daren Ure, Hepion's Chief Scientific Officer. "There is a great deal of well-deserved optimism now that vaccines have been approved. However, for the foreseeable future, we anticipate there will continue to be the need for active antiviral treatments as well as treatment for ARDS. CRV431 potentially offers both."
Largest borrow rate increases among liquid names » 08:4512/1812/18/20
GP, FUBO, TRXC, VLDR, VFF, ROOT, HEPA, IPOC, SOL, LAC
Latest data shows the…
Latest data shows the largest indicative borrow rate increases among liquid option names include: GreenPower Motor Company (GP) 46.52% +9.30, fuboTV (FUBO) 17.16% +4.20, TransEnterix (TRXC) 10.44% +0.26, Velodyne Lidar (VLDR) 11.41% +0.24, Village Farms International (VFF) 14.34% +0.19, Root Inc (ROOT) 3.30% +0.18, Hepion Pharmaceuticals (HEPA) 19.68% +0.18, Social Capital Hedosophia Holdings III (IPOC) 1.09% +0.17, ReneSola (SOL) 16.48% +0.15, and Lithium Americas (LAC) 16.63% +0.14.
Hepion Pharmaceuticals announces results of study on CRV431 » 07:3912/0212/02/20
Hepion Pharmaceuticals announced results from a translational research study in which its lead drug candidate, CRV431, decreased formation of a novel class of human blood platelets, called 'procoagulant platelets.' High levels of procoagulant platelets have been associated with transient ischemic attack and stroke.Patients with advanced liver disease often have coagulopathy disorders, diabetes, and dyslipidemia, and may develop hemorrhagic and ischemic diseases including stroke.2 For example, patients with nonalcoholic fatty liver disease and NASH have an increased risk for ischemic stroke, which accounts for 87% of strokes in the United States and is the second leading cause of death globally.3 Additionally, patients with NAFLD may experience more severe stroke which may require more aggressive management of liver disease.4 Nonclinical studies have reported that cyclophilins, the enzymes inhibited by CRV431, contribute to platelet activities, which prompted Hepion to undertake the present in vitro study to examine the effects of CRV431 on platelets.
Hepion Pharmaceuticals price target lowered to $8 from $14 at Roth Capital » 07:5212/0112/01/20
Roth Capital analyst…
Roth Capital analyst Elemer Piros lowered the firm's price target on Hepion Pharmaceuticals to $8 from $14 and keeps a Buy rating on the shares. The analyst notes that Hepion closed a follow on offering of 23M shares priced at $1.50/share, which caused a significantly higher dilution than he previously anticipated.
Hepion Pharmaceuticals 20M share Spot Secondary priced at $1.50 » 19:3511/2411/24/20
The deal priced below the…
The deal priced below the last closing price of $2.18. ThinkEquity is acting as sole book running manager for the offering.
Hepion says DSMB approves continuation of Phase 2a Ambition trial » 07:4411/1811/18/20
Hepion Pharmaceuticals announced that an independent Data Safety Monitoring Board, DSMB,has approved the continuation of the company's Phase 2a 'AMBITION' clinical trial to the next dose level cohort, after evaluating the safety and tolerability of the 75 mg CRV431 dose cohort in NASH patients. The study will now enroll NASH patients in the 225 mg dose cohort.The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. In this study, CRV431 is administered orally, once-daily for 28 days. The primary objectives of the trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. The secondary outcome measure of the trial is to evaluate decreases in non-invasive antifibrotic markers from baseline to the end of study. The study is being conducted at 10 sites in the U.S.less than/pgreater thanless thanpgreater thanDr. Stephen Harrison MD, Hepion's Consultant Medical Director, commented, "The DSMB review of the first CRV431 dose cohort in the Phase 2a AMBITION trial affirmed there were no safety or tolerability concerns. Moreover, when focusing on parameters of liver chemistry safety labs, reductions in ALT and AST were observed at Day 28. These data are very encouraging for the continued development of CRV431 as an oral, once-daily antifibrotic treatment for NASH patients."We are pleased with the DSMB's positive recommendation and look forward to continuing our AMBITION trial in NASH patients with moderate-to-severe fibrosis," commented Dr. Robert Foster PharmD, PhD, Hepion's CEO. "There are currently no approved treatments for NASH, which affects approximately 17 million people in the U.S. and may lead to cirrhosis, cancer, and death.
Roth Capital to hold a webinar » 08:3010/2810/28/20
ACER, APLS, ARDS, CRVS, CWBR, DRRX, HEPA, HGEN, IMUX, LIFE, RDHL, TFFP, XAIR
COVID-19 Therapeutics in…
COVID-19 Therapeutics in Development will be held on October 28 at 9 am. Webcast Link
|Over a quarter ago|
Hepion Pharmaceuticals reports 'positive activity' of CRV431 against SARS-CoV-2 » 08:1909/1709/17/20
Hepion Pharmaceuticals said in a release, "Hepion Pharmaceuticals announced that a study of Hepion's CRV431 conducted by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH, demonstrated positive antiviral activity against SARS coronavirus-2 (SARS-CoV-2). Under NIAID's suite of preclinical services, or PCS, and with NIAID funding, Hepion was able to study the impact of CRV431 on SARS-CoV-2. This in vitro study tested CRV431 at concentrations of 0.0032 to 10 microM and a positive control compound, a protease inhibitor, at 0.032 to 100 microgram/ml in Caco-2 cells infected with SARS-CoV-2. CRV431 treatment was found to inhibit production of infectious virus in these cells with almost five-times greater potency than the positive control compound in this study. The concentration of CRV431 required to inhibit virus production by 90% (IC90) was 1.5 microM versus 7.3 microM for the positive control compound. Separate experiments that evaluated cellular toxicities independent of virus infection showed no significant CRV431 cellular toxicity, indicating that CRV431 antiviral activity was due to specific effects on the virus."
Hepion Pharmaceuticals completes final dosing in Phase 1b MAD study of CRV431 » 07:3509/0109/01/20
Hepion Pharmaceuticals said in a release, "Hepion Pharmaceuticals announced that CRV431 dosing has now been completed in all subjects enrolled in the Phase 1b multiple ascending dose, or MAD, study of CRV431. The open-label MAD study was designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days. The study examined doses of 75 mg, 150 mg, 225 mg, 300 mg and 375 mg."