Ananda Pharma Completes Phase 1 Study of MRX1 Cannabidiol Oral Solution for Chronic Pain

Ananda Pharma Reports Positive Phase 1 Results for MRX1

UK-based Ananda Pharma has announced the successful completion of its Phase 1 pharmacokinetic study evaluating MRX1, the company’s cannabidiol oral solution being developed for the treatment of chronic pain conditions.

According to the company, all primary study objectives were achieved. The trial demonstrated a favorable safety and tolerability profile across the tested dose levels, providing important support for the continued development of MRX1. The results also help establish dose selection for upcoming Phase 2 clinical studies.

Study Supports Advancement Into Phase 2 Development

The Phase 1 trial was designed to assess the pharmacokinetics, safety, and tolerability of MRX1 in healthy adult volunteers.

A total of 20 participants received at least one dose of the investigational therapy. Participants were divided into two dosing groups:

• 10 participants received MRX1 at 2.5 mg/kg twice daily

• 10 participants received MRX1 at 7.5 mg/kg twice daily

After a 14-day washout period, nine participants from the lower-dose group received a single 2.5 mg/kg dose following a high-fat, high-calorie meal to evaluate the impact of food on drug absorption.

The findings from the study are expected to support future clinical development and help guide the design of Phase 2 trials.

Strong Safety and Tolerability Profile Observed

Ananda Pharma reported that MRX1 was generally well tolerated under all study conditions.

Healthy volunteers received twice-daily dosing for six days under fasting conditions at both dose levels. Researchers also evaluated a single fed-dose administration at the lower dose level.

All treatment-emergent adverse events reported during the study were mild in severity. Importantly, there were:

• No serious adverse events

• No moderate or severe adverse events

• No study withdrawals due to adverse events

• No deaths related to treatment

The company also noted that there were no clinically meaningful changes in laboratory parameters throughout the study period.

Liver Function Remained Stable Throughout the Trial

One of the important findings from the study was the absence of significant liver-related safety concerns.

Researchers reported no abnormal clinically significant laboratory findings during the trial, including liver function measurements. This observation is particularly important for the long-term development of cannabidiol-based therapies.

The safety profile observed in the study was consistent with the established clinical experience of currently approved CBD medicines.

According to the company, these findings further support its regulatory strategy utilizing the FDA’s 505(b)(2) development pathway.

CEO Highlights Next Development Milestones

Melissa Sturgess, Chief Executive Officer of Ananda Pharma, described the completion of the study as a significant achievement for the company.

She stated that the positive data place Ananda in a strong position as it prepares to begin dosing patients in its upcoming ENDOCAN and ACTION Phase 2 clinical trials.

The company believes the successful completion of the Phase 1 program provides additional confidence in both the clinical development plan and the broader regulatory strategy for MRX1.

MRX1 Being Developed for Chronic Pain Conditions

MRX1 is Ananda Pharma’s cannabidiol oral solution candidate being developed to treat complex and chronic conditions, including chronic pain.

The investigational therapy is part of the company’s broader focus on developing regulatory-approved cannabidiol medicines. With encouraging Phase 1 results now in hand, Ananda is preparing to move into the next stage of clinical evaluation, where the therapy will be studied directly in patient populations.

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