ViralClear halts its Phase 2 Hospitalized COVID-19 Trial

▴ ViralClear halts its Phase 2 Hospitalized COVID-19 Trial
ViralClear Pharmaceuticals, Inc. announced the halting of its signal finding Phase 2 hospitalized Covid-19 trial.

BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), announced the halting of its signal finding Phase 2 trial, “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19)”.

After the implementation of a protocol amendment that expanded the size of the trial from 40 to 80 hospitalized COVID-19 patients, and that limited enrollment to seriously ill patients, (NIAID Grade 3, who required high flow, high concentration oxygen to maintain adequate oxygenation) the Safety Monitoring Committee (SMC) was unblinded for safety reasons since these patients are at higher risk for dying from their disease. At the time of the most recent review of the data by the SMC, 44 patients had been enrolled in the trial of whom 42 had received study drug (either merimepodib solution or matching placebo).

This most recent review of the data documented all 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37 day follow-up period.  However, patients who were NIAID Grade 3 patients (n = 20) at the time of enrollment had markedly different outcomes. Specifically, the unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib making it unlikely that the trial would meet its primary safety endpoints. The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered.

At this time, the Company does not intend to further develop merimepodib. However, the Company will see if other parties are interested in acquiring or licensing merimepodib.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with

(i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed,

(ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties;

(iii) difficulties in obtaining financing on commercially reasonable terms;

(iv) changes in the size and nature of our competition;

(v) loss of one or more key executives or scientists; and

(vi) difficulties in securing regulatory approval to market our products and product candidates.

More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

Tags : #viralclear #phase2trial #biosigtechnologies #covid19patients #hospitalizedcovid19trial

About the Author


Rohit Sharma

Writer, Health Enthusiast, and an Accountant, Rohit Sharma is a writer at medicircle, penning down his thoughts about healthcare research, innovations, trends in healthcare and simply all about healthcare. Write to rohit on [email protected]

Related Stories

Loading Please wait...
-Advertisements-


Trending Now

Covid technical Advisory panel advises Karnataka health dept to be prepared for 2nd wave of COVID-19 pandemicDecember 04, 2020
Telangana reports 631 fresh cases of COVID-19December 04, 2020
Odisha crosses milestone in conducting over 6 million tests for COVID-19December 04, 2020
New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary EndpointDecember 04, 2020
Shape Therapeutics Unveils AAVid™ Capsid Discovery Platform and Identification of Novel Tissue-Specific AAV Variants, Solving a Fundamental Delivery Challenge in Gene TherapyDecember 04, 2020
ReAlta Life Sciences Announces EMA Orphan Drug Designation for RLS-0071 for the Treatment of Neonatal EncephalopathyDecember 04, 2020
I2O Therapeutics receives strategic investment from Colorcon VenturesDecember 04, 2020
Study shows personalized provider navigation using machine intelligence may reduce post-surgical hospitalizations and lower costsDecember 04, 2020
Zydus receives approval from DCGI to commence Phase III clinical trials with Pegylated Interferon alpha-2b in India December 04, 2020
PharmaEngine, Inc. collaborates with Sentinel Oncology for SOL-578, a Chk1 inhibitorDecember 04, 2020
Rhizen Pharmaceuticals Announces US FDA Acceptance of its IND ApplicationDecember 04, 2020
1450 new cases of COVID-19 reported in Madhya PradeshDecember 04, 2020
COVID-19 recovery rate in country improves to 94.20 pctDecember 04, 2020
Over 11,70,000 samples tested for COVID-19 across country in last 24 hoursDecember 04, 2020
Britain to cover COVID-19 vaccine side-effects under damages schemeDecember 04, 2020
India’s Active Caseload further dips to 4.35% of Total CasesDecember 04, 2020
COVID-19 recovery rate in Bihar improves to 97.12 pctDecember 04, 2020
Gujarat records 1540 new cases of COVID-19December 04, 2020
Catalyst Biosciences receives FDA Fast track designation for subcutaneous MarzAADecember 04, 2020
AbbVie and Frontier Medicines establish global partnership for research and developmentDecember 04, 2020