AcelRx to Host KOL Panel Discussion on Current Anticoagulant Use in Dialysis and the Upcoming Niyad™ Clinical Study

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Nov 07, 2023, 16:05 ET

Two KOLs will discuss recent quantitative market research on the use of anticoagulants in the dialysis circuit

Discussion will also focus on the Niyad study protocol for upcoming NEPHRO Study

Register to attend the webcast event on December 6, 2023 at 11:00 a.m. ET

SAN MATEO, Calif., Nov. 7, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will host a virtual Key Opinion Leader (KOL) panel discussion on its lead candidate Niyad™ (nafamostat) for use as an anticoagulant in dialysis circuits. The panel will feature two thought-leaders in the nephrology and critical care fields who are also co-authors on a recent market research manuscript reporting current issues with anticoagulants in the dialysis circuit. The panel will also discuss the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, a registrational study comparing Niyad with placebo for dialysis circuit anticoagulation, which is planned to start in the fourth quarter. Both panel members are principal investigators in the trial.

The webcasted event will take place on Wednesday, December 6, 2023 at 11:00 a.m. ET / 8:00 a.m. PT.

To register for the event, click here.

The event will include a discussion led by Pamela Palmer, M.D., Ph.D., co-founder and Chief Medical Officer of AcelRx, and features KOLs Laurence Busse M.D., M.B.A. (Emory University School of Medicine) and David W. Boldt, M.D. (UCLA Medical Center).

A live question and answer will follow the discussion.

About Laurence Busse M.D., M.B.A.

Laurence Busse MD, MBA, completed his medical education at George Washington University, where he stayed on for his Internal Medicine residency, and fellowship training in Critical Care Medicine. He worked as an Intensivist in northern Virginia before joining Emory University in 2016 as the Medical Director of critical care at Emory Saint Joseph's Hospital. He currently serves as Medical Director for critical care at Emory Johns Creek Hospital. Prior to his medical career, Dr. Busse received his Masters degree in Business Administration from Emory University. His areas of research and interest include the examination of the sequelae of high output shock, including catecholamine resistant hypotension and acute kidney injury. Dr. Busse has been involved in early clinical work exploring the use of angiotensin II as a novel therapeutic agent in catecholamine resistant hypotension. He is actively engaged as an intensivist and supervises trainees in Emory Johns Creek Hospital's intensive care unit.

About David W. Boldt, M.D.

David W. Boldt, MD is an Anesthesiologist and Critical Care Intensivist at UCLA Medical Center in Los Angeles, CA. He divides his clinical time between the operating room, where he is the Division Chief of Trauma and Adult Multi-specialty Anesthesiology, and the Cardiothoracic Intensive Care Unit, where he takes care of patients after heart and lung surgery including transplants and mechanical circulatory support, such as extracorporeal membrane oxygenation. He is an avid clinical researcher in both the operating room and ICU on topics such as acute kidney injury, sepsis, vasoconstrictor therapy, atrial fibrillation, and ECMO. Dr. Boldt has been invited as a speaker both nationally and internationally, including being faculty and three-time speaker at the International Society of Intensive Care and Emergency Medicine, which is held annually in Brussels, Belgium, and is the largest meeting of critical care and emergency medicine in the world.

About Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the FDA. AcelRx is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.

Forward-looking statements

This press release contains forward-looking statements based upon AcelRx's current expectations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "potential", "believe", "expect", "expects", "expected", "anticipate", "upcoming", "may", "will", "enable," "should," "seek", "approximately", "intends", "intended", "plans", "planned", "planning", "estimates", "benefits", or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to AcelRx's product development activities and ongoing commercial business operations; (ii) risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for AcelRx's commercial and developmental products and technologies; (iv) risks related to AcelRx's liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; (v) AcelRx's ability to retain its listing on the Nasdaq exchange; and (vi) risks relating to AcelRx's ability to obtain regulatory approvals for its developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

SOURCE AcelRx Pharmaceuticals, Inc.