MAXONA PHARMACEUTICALS ANNOUNCES MAX-OO1 PHASE 1 CLINICAL PROGRAM RESULTS

MAX-001 is a Non-Opioid, Non-NSAID Oral Therapy in Development for Treatment of Acute and Chronic Pain

Preliminary Results of Phase 1 Clinical Trial Demonstrate MAX-001 is Well Tolerated with no Serious Adverse Events or Treatment Related Discontinuations

MALVERN, Pa., March 18, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the preliminary results of the Phase 1 clinical program for MAX-001, which is in development as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. The results show that MAX-001 was well tolerated with no serious adverse events or treatment related discontinuations.

MAXONA Pharmaceuticals is developing MAX-001 as a proprietary optimized formulation of nefopam, which has been studied extensively and widely prescribed outside the United States as a treatment for moderate to severe acute and chronic pain. MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia exerting its effect primarily through a novel mechanism of action as a triple neurotransmitter re-uptake inhibitor with a potency profile being significantly greater for norepinephrine than serotonin, and dopamine respectively (N > S > D). When approved for use, MAX-001 will be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain in the United States.

"From an overall perspective, our goal in developing MAX-001 is to provide a significant new non-opioid, non-NSAID treatment for patients in the United States," said Shawn Fatholahi, President & CEO, MAXONA Pharmaceuticals. "In particular, we are focused on developing MAX-001 as a proprietary optimized formulation of nefopam that will provide rapid onset of action and extended duration of effect. We are pleased with the results of our Phase 1 clinical program, which seem to demonstrate the safety and tolerability of MAX-001 as an oral therapy being developed for acute and chronic pain. The results of the Phase 1 clinical program will also help to inform our work as we advance MAX-001 to Phase 2 clinical trials later this year."

The MAX-001 Phase 1 study (Study MAX-001-101) was a 3-stage study that included 94 healthy participants who received a total of 432 doses of study drug. Stage 1 was designed to assess the pharmacokinetics and safety of 3 novel immediate and controlled release formulations of MAX-001 and the potential food-effect of 2 selected formulations. Stages 2 and 3 were randomized, double-blind, and placebo-controlled and studied the safety and pharmacokinetics of single ascending (SAD) and multiple ascending (MAD) doses and dosing regimens across a wide dose range (30mg to 240mg). The data from this study will inform the formulation and dose range that will be advanced to Phase 2.

"The results of Study MAX-001-101 provide further evidence of the safety, tolerability and pharmacokinetics of nefopam that is consistent with decades of published research and clinical experience," said Roy Freeman, MD, Professor of Neurology and Director, Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center. "The study results affirm that the MAX-001 proprietary optimized formulation had well behaved and dose-proportional pharmacokinetics and was safe and well tolerated. Building on a body of data showing efficacy in acute pain models, the results of the Phase 1 study offer further evidence of the potential for MAX-001 to become an important new option for patients in the United States who are suffering from acute and chronic pain."

"Study MAX-001-101 is the latest addition to our MAX-001 development program, which also includes comprehensive IND-enabling pre-clinical studies," said Robert Rubens, MD, MBA, FAAN, and Clinical Development lead for MAXONA Pharmaceuticals. "In the study, most reported treatment-emergent adverse events were assessed as 'mild' in severity. There were no reported serious adverse events, premature discontinuations due to related adverse events, or severe adverse events. There were no concerning findings or abnormal trends in clinical labs, ECGs, and vital signs. We look forward to presenting and publishing the Study MAX-001-101 full data set later this year."

About MAXONA Pharmaceuticals

MAXONA Pharmaceuticals, headquartered in Malvern, PA, is a privately held clinical-stage pharmaceutical company committed to developing the next generation of therapies to help patients maximize life. The company is distinguished by its strong and diversified leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, clinical trial design and pharmacology to develop patient-centric therapies that are safe, efficacious, clinically proven and trusted by physicians and their patients. The company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid option for the treatment of acute and chronic pain.

For more information, please visit www.maxonapharm.com.

Cautionary Statement Regarding Forward Looking Statements

This release may contain "forward-looking statements". Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

Dr. Roy Freeman receives compensation and equity as a Senior Medical Advisor to MAXONA Pharmaceuticals.

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SOURCE Maxona Pharmaceuticals