TEL AVIV, Israel, Dec. 27, 2024 (GLOBE NEWSWIRE) -- PainReformLtd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.
PainReform previously disclosed initial topline data from its Phase 3 clinical trial in which it reported that it demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. Yet, at that time, data pertaining to the last 24-hour period of the 72-hour study follow-up was unclear, and efforts were made to resolve the incoherence and complete the analysis.
Following further investigation, PainReform has determined that the data from the final 24-hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement, and therefore, it did not meet the primary endpoint of the study. Despite this setback, the Company has initiated research and development (R&D) activities to better understand and refine the pharmaco-kinetics and pharmaco-dynamics of PRF-110 based on the data received from the study. These efforts are intended to potentially resolve this issue to support future clinical trials.
"We are focused on resolving the issue of the last 24 of the 72-hour requirement through the use of high-level, in-vitro models prior to any additional clinical work," said Dr. Ehud Geller, Chairman and interim CEO of PainReform. "This update reflects our determination to leverage these learnings and continue our mission to provide effective pain relief solutions for surgical patients. Our ongoing R&D efforts aim to deepen our understanding of PRF-110’s profile and enhance its potential in future evaluations. In parallel, we are reviewing our strategic options. There can be no assurance that our review will result in any transaction or that it will enhance shareholder value.”
AboutPainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. The Company's proprietary extended- release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit www.painreform.com.
NoticeRegardingForward-LookingStatements
This press release contains forward-looking statements about our expectations, beliefs and intentions including with respect to objectives, plans and strategies and expected timing of results. Forward-looking statementscanbeidentifiedbytheuseofforward-lookingwordssuch
as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will","project","forecast","continue"or"anticipate"ortheirnegativesorvariationsofthese words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, currentconditions,expectedfuturedevelopmentsandotherfactorsbelievedtobeappropriate. Forward-lookingstatements inthis press releasearemade asofthedateofthispressrelease, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of futureperformanceandaresubjecttorisksanduncertainties,manyofwhichareoutsideofour control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, thefollowing:ourabilitytoidentify,evaluateandcompleteanystrategicalternativethatyields valueforourshareholders,ourabilitytocontinueasagoingconcern,ourhistoryofsignificant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110andfutureproduct candidates;ourlimitedexperiencemanagingclinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competitionandnewtechnologies;ourabilitytocomplywithregulatoryrequirementsrelating to the development and marketing of our product candidates;our ability to establish and maintainstrategicpartnershipsandothercorporatecollaborations;theimplementationofour business model and strategic plans for our business and product candidates; the scope of protectionweareabletoestablishandmaintainforintellectualpropertyrightsandourability tooperateourbusinesswithoutinfringingtheintellectualpropertyrightsofothers;theoverall globaleconomicenvironment;ourabilitytodevelopanactivetradingmarketforourordinary sharesandwhetherthemarketpriceof ourordinarysharesisvolatile; ourabilitytomaintain our listing on the Nasdaq CapitalMarket; and statements astothe impact of the political and security situation in Israel on our business, including due to the current war in Israel. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
