Professor Eli Hazum to Share Positive Safety and PK Data of PRF-110 from First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
Tel Aviv, Israel – September 7, 2023 – PainReform Ltd. (Nasdaq: PRFX) (“PainReform” or the “Company“), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced that Company has been selected for a poster presentation, titled “Pharmacokinetics and Safety Profiles of PRF-110 in Subjects Following Bunionectomy Surgery,” at the upcoming 13th Congress of the European Pain Federation (EFIC) being held September 20-22, 2023 at the HUNGEXPO Exhibition Centre in Budapest, Hungary. The poster will be presented by Professor Eli Hazum, Chief Technology Officer of PainReform, on September 20, 2023. The poster will be available on the EFIC website after the meeting.
The poster presentation will provide further details regarding the positive safety and pharmacokinetic (PK) data from the Company’s first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. PRF-110 was administrated intra-operatively to validate the formulation’s safety and confirm optimal product instillation in the surgical wound. PRF 110 was well tolerated, all adverse events (AEs) were mild, and no serious adverse events (SAEs) were observed.
The Phase 3 trial is a randomized, double-blind, placebo and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia. The upcoming second part of the trial will be a double-blind study, randomizing approximately 400 patients at seven clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo and plain ropivacaine.
Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are honored to announce the acceptance of our poster for presentation at the highly prestigious EFIC Congress, detailing the results from the first part of our Phase 3 clinical trial. The analyses of PRF-110 indicate that the drug is well tolerated and has a favorable PK profile, suggesting a substantial potential advantage to using PRF-110 over the local anesthetic, ropivacaine. This data further reinforces the growing body of clinical evidence supporting our non-opioid, pain-relieving treatment for postoperative pain. Overall, we remain highly encouraged by the outlook for the program and we look forward to proceeding to the second, larger part of the Phase 3 clinical trial.”
About The European Pain Federation (EFIC)
The European Pain Federation (EFIC) is a non-profit organization representing healthcare professionals in the fields of pain management and pain science. 13th Congress of the European Pain Federation is the main European congress for all healthcare professionals working in pain management featuring cutting-edge pain research and hot topics in pain science. For more information, please visit: https://europeanpainfederation.eu.
About PainReform
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.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these 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, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, 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 future performance and are subject to risks and uncertainties, many of which are outside of our 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, the following: our history of significant 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-110 and future product candidates; the impact of the COVID-19 pandemic on our operations; our limited experience managing clinical 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 competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; commercial success and market acceptance of our product candidates; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; and statements as to the impact of the political and security situation in Israel on our business. 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
Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: ihadar@painreform.com
