PainReform Ltd. Announces Favorable Wound Healing Data in Human Clinical Trials for PRF-110

Rhea-AI Summary

PainReform (Nasdaq: PRFX) has announced favorable wound healing data from human clinical trials for its lead product, PRF-110. The trials, involving both hard tissue (bunionectomy) and soft tissue (hernia) surgeries, showed that PRF-110 promoted normal wound healing and prevented scar formation. These results build upon previous preclinical studies that demonstrated PRF-110's compatibility with normal wound healing.

Key points:

• PRF-110 contains 55% lecithin, which forms liposome-like structures potentially enhancing wound healing
• No abnormalities in wound healing or scar formation were observed in patients treated with PRF-110
• The company is on track to report top-line results from the Phase 3 trial in the second half of 2024

These findings support PRF-110's potential to provide effective post-surgical pain relief while promoting normal wound healing, potentially enhancing patient outcomes.

Positive

• Favorable wound healing data from human clinical trials for PRF-110
• PRF-110 promoted normal wound healing and prevented scar formation in both hard and soft tissue surgeries
• Company on track to report Phase 3 trial top-line results in second half of 2024
• PRF-110's formulation includes 55% lecithin, which may enhance wound healing

Negative

• None.

Insights

Medical Research Analyst

The favorable wound healing data from PainReform's human clinical trials for PRF-110 is a significant development. The results show that PRF-110 promotes normal wound healing and prevents scar formation following surgical procedures, which is important for post-operative recovery. This is particularly noteworthy because:

• PRF-110's formulation includes 55% lecithin, forming liposome-like structures that may enhance wound healing.
• The study covered both hard tissue (bunionectomy) and soft tissue (hernia) surgeries, demonstrating versatility.
• Results align with previous animal studies, showing no adverse effects on soft or bony tissues.

While these findings are promising, investors should note that the full impact on PRF-110's market potential will depend on the upcoming Phase 3 trial results expected in H2 2024. If positive, this could position PRF-110 as a dual-benefit product for pain relief and wound healing, potentially expanding its market appeal and competitive edge.

Financial Analyst

From a financial perspective, PainReform's positive wound healing data for PRF-110 could have significant implications:

• Market differentiation: The dual benefit of pain relief and enhanced wound healing could set PRF-110 apart in a competitive market.
• Potential pricing power: If proven effective, PRF-110 might command a premium price, boosting potential revenues.
• Expanded indications: Positive wound healing properties could lead to broader applications, increasing the addressable market.

However, investors should remain cautious. The company's financial success hinges on the upcoming Phase 3 trial results and subsequent regulatory approval. Additionally, as a clinical-stage company, PainReform likely faces ongoing cash burn. The stock's performance may be volatile until definitive results are available. Investors should closely monitor the Phase 3 trial progress and the company's cash position leading up to the expected H2 2024 data readout.

PRF-110 promoted normal wound healing and prevented scar formation following surgical procedures

Company reaffirms it is on track to report top-line results from the Phase 3 trial in the second half of 2024

TEL AVIV, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, announces positive wound healing data from its human clinical trials investigating the efficacy of PRF-110, the Company’s lead asset designed to provide extended, non-opiate, post-surgical pain relief.

Building on extensive preclinical research, PainReform previously conducted wound healing studies in animal models which demonstrated that PRF-110 allows for normal wound healing of surgical incisions comparable to both Naropin® (ropivacaine) and saline. Importantly, these studies showed no adverse histological or radiologic effects on soft or bony tissues.

The recent human clinical trials included patients undergoing both hard tissue (bunionectomy) and soft tissue (hernia) surgeries. Results from these trials indicated no abnormalities in wound healing or scar formation among patients treated with PRF-110. Wound healing in all patients was complete and consistent with outcomes expected from surgeries without PRF-110.

PRF-110's formulation includes approximately 55% lecithin, which forms liposome-like structures upon contact with body fluids. This feature is particularly noteworthy as existing literature suggests that lecithin liposomes enhance wound healing through in vitro antioxidant activity and in vivo wound-healing models (J Comp Eff Res. 2019 Nov;8(15):1343). The potential beneficial effects of PRF-110 on the wound healing process are further supported by these in vitro, in vivo, and human studies.

Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, commented, "We are very encouraged by the favorable wound healing data from our human clinical trials for PRF-110. These findings support the potential of PRF-110 not only to provide effective pain relief but also to promote normal wound healing and prevent scar formation. We believe PRF-110 could significantly enhance post-surgical recovery and patient outcomes."

PainReform continues to advance the development of PRF-110 and is on track to report top-line results from the Phase 3 trial in the second half of 2024. These results are expected to further inform the regulatory submission process and potential commercialization plans.

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

Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com

FAQ

What were the results of PainReform's (PRFX) human clinical trials for PRF-110?

PainReform's human clinical trials for PRF-110 showed favorable wound healing data. The trials demonstrated that PRF-110 promoted normal wound healing and prevented scar formation following surgical procedures, with no abnormalities observed in wound healing or scar formation among treated patients.

When will PainReform (PRFX) report top-line results from the Phase 3 trial of PRF-110?

PainReform (PRFX) has reaffirmed that it is on track to report top-line results from the Phase 3 trial of PRF-110 in the second half of 2024.

What types of surgeries were included in PainReform's (PRFX) human clinical trials for PRF-110?

PainReform's human clinical trials for PRF-110 included patients undergoing both hard tissue (bunionectomy) and soft tissue (hernia) surgeries.

How does the formulation of PainReform's (PRFX) PRF-110 potentially enhance wound healing?

PRF-110's formulation includes approximately 55% lecithin, which forms liposome-like structures upon contact with body fluids. Existing literature suggests that lecithin liposomes enhance wound healing through in vitro antioxidant activity and in vivo wound-healing models.