PainReform Completes Enrollment in the Second Part of its Phase 3 Bunionectomy Trial for PRF-110

Rhea-AI Summary

PainReform has successfully completed patient enrollment for the second part of its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate aimed at treating post-operative pain. The double-blind, placebo-controlled study enrolled 428 patients across eight U.S. sites. The trial's primary endpoint is to determine the drug's efficacy in reducing post-operative pain intensity over 72 hours compared to a placebo. Secondary endpoints include comparisons with Naropin and assessments of safety and rescue analgesic use. The company anticipates reporting top-line data in the second half of 2024, a critical step towards regulatory submission and potential commercialization.

Positive

• Successful completion of patient enrollment for Phase 3 trial of PRF-110.
• Enrollment of 428 patients across eight U.S. clinical sites.
• Primary endpoint: efficacy in reducing post-operative pain intensity compared to placebo.
• Secondary endpoints: comparisons with Naropin, rescue analgesics usage, and safety evaluations.
• Top-line data expected in the second half of 2024, moving closer to regulatory submission and potential commercialization.

Negative

• None.

Insights

Medical Research Analyst

The completion of patient enrollment in PainReform's Phase 3 clinical trial for PRF-110 marks a significant step forward in the development of novel non-opioid analgesics. PRF-110's extended-release formulation based on ropivacaine could address a substantial need in post-operative pain management amid the ongoing opioid crisis. By employing a randomized, double-blind, placebo-controlled study design, the trial ensures a high standard of scientific rigor conducive to regulatory approval.

From a clinical perspective, the primary endpoint focused on pain reduction within the first 72 hours post-surgery is crucial. If PRF-110 demonstrates statistically significant results compared to placebo and Naropin, it could position the drug as a preferred option in perioperative pain management. Secondary endpoints, such as reduced need for rescue analgesics and overall safety, are equally important in establishing comprehensive efficacy and safety profiles.

For investors, the announcement suggests that PainReform is on track with its clinical timeline, with top-line data expected in the second half of 2024. Positive results could catalyze regulatory submission and eventual market entry, although investors should be mindful of the inherent uncertainties in clinical research.

Financial Analyst

The completion of the enrollment phase in PainReform's Phase 3 trial for PRF-110 is a milestone that signals the company's progress towards potential commercialization. This phase is typically the most resource-intensive part of a clinical trial and its successful completion often reflects well on the company's operational capabilities and financial health.

Considering the market potential for non-opioid analgesics, PRF-110 could capture significant market share if it proves effective. The opioid crisis has heightened demand for alternative pain management solutions and PRF-110's extended-release, non-opioid formulation positions it well to meet this demand. The anticipated reporting of top-line data in the second half of 2024 could act as a catalyst for the stock, potentially attracting both institutional and retail investors.

However, investors should exercise caution. The clinical trial results will need to be robust to justify the company's current valuation. Additionally, potential regulatory hurdles and competitive pressures from other non-opioid pain management solutions must be considered.

Market Research Analyst

From a market perspective, completing the patient enrollment for the Phase 3 trial of PRF-110 indicates significant progress in PainReform's development timeline. The focus on a non-opioid analgesic is particularly timely, given the ongoing opioid crisis and the urgent need for safer pain management alternatives. The extended-release formulation offers a strong value proposition, potentially simplifying pain management protocols and improving patient outcomes.

PainReform's decision to focus on bunionectomy, a common outpatient procedure, is strategic. Positive results in this indication could be extrapolated to other surgical procedures, broadening the market scope. Moreover, the company's commitment to high scientific standards (randomized, double-blind, placebo-controlled study) adds credibility and could enhance the drug's appeal to both healthcare providers and payers.

In the short term, completing this phase could stabilize the company’s stock by reducing clinical development risk. In the long term, successful trial outcomes and subsequent regulatory approvals could significantly impact the company's market position and revenue streams.

Top line data to be reported in the second half of 2024

TEL AVIV, Israel, June 26, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of post-operative pain. In total, 428 patients have been enrolled at eight clinical sites across the U.S. As the study pain score is being tracked for 72 hours, the end of enrollment is generally the end of the clinical part of the study.

The Phase 3 trial, a randomized, double-blind, placebo-controlled study, is designed to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure. Completion of enrollment in this trial marks a significant milestone in the development of PRF-110 and brings the Company closer to potentially offering a new, non-opioid pain management solution to patients and healthcare providers. This innovative drug candidate leverages a patented, oil-based, extended-release formulation of the well-established local anesthetic, ropivacaine, to provide effective and prolonged pain relief.

The Company anticipates reporting top-line results from the Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.

"Completing enrollment in the second part of our Phase 3 trial for PRF-110 is a major achievement for PainReform," said Dr. Ehud Geller, Executive Chairman of Pain Reform. "We remain highly encouraged by the outlook for PRF-110, based on our clinical trial results thus far, including our Phase 2 trial results and the first part of our Phase 3 trial. With the opioid crisis continuing to affect millions worldwide, there is an urgent need for effective pain management alternatives that do not carry the risks associated with systemic opioids. PRF-110 is poised to be a game-changer and we remain highly confident PRF-110 has the potential to fill a critical gap in healthcare and significantly improve the quality of post-operative care."

The trial's primary endpoint is to demonstrate a significant reduction in post-operative pain intensity compared to placebo over the first 72 hours after surgery. Secondary endpoints include reduction in post-operative pain intensity compared to Naropin (ropivacaine), evaluating the total consumption of rescue analgesics and the overall safety and tolerability of PRF-110.

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 including with respect to objectives, plans and strategies and expected timing of results. 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 ability to continue as a going concern, 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;  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; 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, including due to the current war between Israel and Hamas. 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
egeller@medicavp.com

FAQ

What is the focus of PainReform's Phase 3 trial for PRF-110?

The Phase 3 trial aims to evaluate the efficacy and safety of PRF-110 in reducing post-operative pain in patients undergoing bunionectomy.

How many patients were enrolled in the Phase 3 trial for PRF-110?

A total of 428 patients were enrolled in the Phase 3 trial at eight clinical sites across the U.S.

When will PainReform report the top-line data for the PRF-110 Phase 3 trial?

PainReform anticipates reporting top-line data in the second half of 2024.

What are the primary and secondary endpoints of the PRF-110 Phase 3 trial?

The primary endpoint is a significant reduction in post-operative pain intensity compared to placebo. Secondary endpoints include comparisons with Naropin, total consumption of rescue analgesics, and overall safety and tolerability.

What is the potential market impact of PRF-110?

PRF-110 aims to provide a non-opioid pain management solution, potentially filling a critical gap in healthcare and offering an alternative to systemic opioids for post-operative pain relief.