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PRF Technologies Ltd. reports developments across clinical-stage specialty pharmaceuticals and AI-driven solar analytics. The company focuses on reformulating established therapeutics for post-operative pain management and, through majority-owned LayerBio, is developing OcuRing™-K, a bio-erodible intraocular ring designed to deliver ketorolac for post-cataract pain and inflammation.
PRF news also covers the company’s DeepSolar business unit, which develops AI-driven digital asset management, forecasting, performance monitoring, and technical due diligence tools for utility-scale solar plants. Recurring updates include ocular drug-delivery regulatory milestones, preclinical and clinical safety data, patent activity, SaaS deployments, commercial collaborations, capital actions, and governance changes.
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.
PainReform (Nasdaq: PRFX) has announced a significant advancement in the development of its lead asset, PRF-110. The company's new highly scalable manufacturing process has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This milestone is important for ensuring the drug's safety and efficacy, while also simplifying handling, transportation, and reducing associated costs.
The stability study is ongoing and marks a significant achievement for PainReform. The company recently filed a new patent for this manufacturing process, which is expected to significantly bolster future commercialization efforts. PainReform is on track to report top-line results from its Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.
PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:
- Continuous Process Manufacturing for increased productivity
- Single Reactor Manufacturing for reduced costs and contamination risk
- Enhanced Batch Size capabilities while maintaining quality
These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.
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.
PainReform, a clinical-stage specialty pharmaceutical company, announced it received a notification from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share set forth in Listing Rule 5550(a)(2). The company has 180 days, from May 28, 2024, to November 25, 2024, to regain compliance by maintaining a closing bid price of at least $1 for a minimum of ten consecutive business days. Failure to do so may result in delisting, although the company may be eligible for an additional compliance period if it meets other listing standards. The notification does not immediately affect PainReform’s Nasdaq listing or trading under the symbol 'PRFX'.
PainReform provided a business update for Q1 2024, noting significant progress in the clinical development of its lead drug candidate, PRF-110.
The company reached 50% enrollment in the second part of its Phase 3 clinical trial for PRF-110 in bunionectomy, with over 200 patients enrolled across eight U.S. sites. No serious adverse events have been reported.
PainReform expects to announce top-line data in Q3 2024. New studies showed PRF-110's superior in-vitro release rates compared to industry leaders, and the company is optimistic about its potential to reduce opioid use.
Financially, R&D expenses rose to $4.7 million, mainly due to the Phase 3 trial, while general and administrative expenses decreased to $823,000. The company incurred a net loss of $5.5 million. As of March 31, 2024, PainReform held $4.3 million in cash and raised $4 million through a public offering in April 2024.
PainReform CEO, Ilan Hadar, discussed the benefits of PRF-110 in addressing the opioid epidemic during an interview with Proactiveinvestors.com. PRF-110 offers extended post-operative pain relief without opioids, with positive updates on the Phase 3 trial and market potential.
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