PainReform (Nasdaq: PRFX) is developing a proprietary, extended-release drug-delivery system 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 systemic opioids. PRF-110 was created to prolong the in vivo activity of APIs (active pharmaceutical ingredients) at the surgical site, thus facilitating early post-operative ambulation, treating pain without the need to use opioids.
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The company’s lead product candidate, PRF-110, is based on the local anesthetic ropivacaine, targeting the post-op pain relief market. PRF-110 is an oil-based, viscous, waterless and clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia. This extended-release drug delivery system can be used for the delivery of different types of drugs that are currently difficult to administer for long-term, continuous dosing without an intravenous access, including antibiotics and chemotherapeutics.
A successful Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair) demonstrated that PRF-110 provided substantial pain reduction for up to 72 hours post-operatively, a substantial improvement over the local anesthetic, Ropivacaine, alone. PRF-110 clearly excelled in terms of surface/tissue spreading and staying in place—a key advantage in achieving effective post-surgical pain relief, as it is critical to have even distribution inside the surgical wound. PRF-110 is manufactured via a scalable and cost-effective process, is easy to commercialize, and contains excipients that are all FDA-approved as GRAS (generally regarded as safe), mitigating many potential safety issues common in drug development.
The FDA granted the company an IND (Investigational New Drug) for PRF-110 and approved the initiation of a Phase 3 trials for the treatment of post-op pain. Following the completion of the first part of Phase 3 clinical trial of PRF-110, PainReform is currently conducting the second part of the Phase 3 trial in bunionectomy, which is a double-blind study randomizing approximately 400 patients at six clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo.
History of the company’s formation
PainReform was founded in November 2007 and funded by highly regarded venture capital firms in Israel. PainReform completed its IPO in September 2020 and raised approximately $20 million to advance the Phase 3 clinical trials of PRF-110 for post-op pain.
Key Leadership
PainReform has built a seasoned management team with deep experience launching new pharmaceutical products in the U.S. and Israel, including:
- Ehud Geller, PhD, MBA, Executive Chairman, is the Founder & Managing Partner of Medica Venture Partners and has been active in the healthcare/biopharma and life science industries for over 30 years. As the former president and CEO of Interpharm Laboratories, Ltd., he presided over the growth of the company from the seed stage to $18 million in revenues. Prior to that, Dr. Geller, was the president of the Pharmaceutical Division of Teva and Executive VP of the Teva Group, Israel´s largest pharmaceutical company.
- Ilan Hadar, MBA, Chief Executive Officer, brings over 20 years of multinational managerial experience, leading the operations, R&D, manufacturing, regulatory, and corporate finance for premier healthcare companies in the U.S. and Israel. Formerly, Ilan served as Country Manager and CFO at Foamix Pharmaceuticals Ltd., where he was instrumental in launching new innovative topical drugs, as well as overseeing U.S. capital markets and M&A. Previously, Ilan was Finance Director at Pfizer Pharmaceutical Ltd., where he oversaw all commercial, financial and operational activities of the local entity.
- Eli Hazum, PhD, MBA, Chief Technical Officer, has been a general partner with Medica VC since 1995. He has taken leadership roles within Medica portfolio companies including interim CEO for Collgard Biopharmaceuticals and Ester Neurosciences, where he was responsible for executing Ester’s acquisition by Amarin Pharmaceuticals. He is the author of more than 100 scientific publications and patents in various areas of drug development.
- Dr. Sigal Aviel, PhD, MBA, Chief Operating Officer, brings over 20 years of managerial experience in the biotech industry. Previously, Sigal held the position of Chief R&D Officer at MediWound, where she was responsible for product development through final product approval. Previously she served as a VP of clinical and regulatory affairs at Biokine and directed both platform and project development at Protalix Biotherapeutics.
Looking to the Future
PainReform anticipates a number of key upcoming catalysts in 2024. Following the positive pharmacokinetic data for first part of Phase 3 clinical trial of PRF-110, PainReform initiated the second, larger part of the Phase 3 trial in bunionectomy. PRF-110 was well tolerated in the first part of the Phase 3 clinical trial on 15 bunionectomy patients. No serious adverse events (SAEs) were observed, suggesting a substantial potential advantage to using PRF-110 over opioids.
The first patient was enrolled in October in the second part of this trial, and enrollment is going as expected, and PainReform is looking forward to continued enrollment up to 400 patients at six clinical sites. Given that PainReform is following the 505(b)(2) pathway with the FDA, PainReform expects this will be a very rapid and low cost trial.
On the heels of the bunionectomy trial, PainReform plans to commence a second Phase 3 trial for pain treatment in hernia repair. Upon completion of the Phase 3 studies, PainReform plans to apply for a New Drug Approval for the management of post-operative pain.
Given the fact that an estimated 99% of current surgeries are treated with opiates and PainReform’s extended-release drug-delivery system has broad potential across 50 million surgical procedures performed annually in the U.S, the Company believes that PRF-110 will play an important role as an alternative to systemic opioids, which have contributed to the global opioid crisis. PainReform believes that it is well-positioned to become standard of care in the $12 billion post-operative pain relief market. Learn more.
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