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https://www.einpresswire.com/article/949897515/biomed-industries-inc-presents-positive-phase-2-3-results-of-na-921-for-rett-syndrome-at-world-pediatrics-conference
NA-921 met both coprimary efficacy endpoints in a 12-week study, with favorable tolerability, supporting further Phase 3 development.
SAN JOSE, CALIFORNIA, UNITED STATES, October 15, 2026 /EINPresswire.com/ — Biomed Industries, Inc., a biopharmaceutical company developing therapies for neurological and other serious diseases, announced the presentation of positive Phase 2/3 clinical results for NA-921 (Bionetide™), its investigational oral treatment for Rett syndrome, at the World Pediatrics Conference, held October 5–6, 2026, in Osaka, Japan.
Dr. Lloyd L. Tran, Chief Executive Officer of Biomed Industries, presented “Reimagining Rett Syndrome Treatment: Phase 2/3 Clinical Results of NA-921 Demonstrating Efficacy and Favorable Tolerability.” The presentation described statistically significant improvements in both coprimary efficacy endpoints and a favorable tolerability profile over the 12-week treatment period.
“Rett syndrome places an extraordinary burden on affected individuals and their families, underscoring the need for additional treatment options that combine efficacy with manageable tolerability,” said Dr. Tran. “The improvements observed across both coprimary endpoints, together with the tolerability findings, strengthen our rationale for advancing NA-921 through further clinical development. Our goal is to translate these findings into a meaningful treatment option for girls and women living with Rett syndrome.”
PHASE 2/3 CLINICAL RESULTS
The randomized, double-blind, placebo-controlled study, registered as ClinicalTrials.gov identifier NCT06849973, evaluated oral NA-921 in females aged 5–20 years with Rett syndrome. The results presented included 173 participants: 86 receiving NA-921 and 87 receiving placebo.
NA-921 demonstrated statistically significant improvements versus placebo on both coprimary endpoints:
• Rett Syndrome Behavior Questionnaire (RSBQ): At Week 12, the least-squares mean change from baseline was −5.5 points with NA-921, compared with −1.6 points with placebo, representing a 3.9-point treatment difference favoring NA-921 (p=0.001). Lower scores indicate reduced symptom severity.
• Clinical Global Impression–Improvement (CGI-I): At Week 12, scores were 3.60 with NA-921 and 3.83 with placebo (p=0.002). Lower scores indicate greater clinician-rated improvement.
The study also included a key secondary objective evaluating communication ability.
FAVORABLE TOLERABILITY DURING THE STUDY.
According to the conference abstract, NA-921 was generally well tolerated. Gastrointestinal adverse events were mild and occurred at frequencies comparable to placebo. No serious adverse events were reported, and no participants discontinued treatment, required dose reductions, or withdrew because of adverse events.
These findings support continued evaluation of NA-921. Larger studies and longer follow-up are needed to further characterize its efficacy, safety, and durability of benefit.
ADVANCING TO PHASE 3 CLINICAL DEVELOPMENT
Biomed’s presentation outlined a randomized, double-blind, placebo-controlled Phase 3 study of NA-921, registered as ClinicalTrials.gov identifier NCT06840496, with a target enrollment of 210 participants.
The Phase 3 program is designed to further evaluate treatment effects on Rett syndrome symptoms and overall clinical improvement, with communication ability included as a key secondary assessment.
ABOUT RETT SYNDROME
Rett syndrome is a rare neurodevelopmental disorder that predominantly affects females and is commonly associated with disease-causing variants in the MECP2 gene. The condition can lead to loss of acquired communication and motor skills, repetitive hand movements, seizures, breathing abnormalities, and other significant impairments. Affected individuals often require extensive, lifelong care.
ABOUT NA-921
NA-921, also known as Bionetide™, is an investigational oral drug candidate being developed by Biomed Industries for the treatment of Rett syndrome. NA-921 has not been approved for marketing, and its safety and efficacy remain under investigation.
ABOUT BIOMED INDUSTRIES, INC.
Biomed Industries, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing transformative therapies for chronic and complex diseases. The company's investigational pipeline addresses Alzheimer's disease, major depressive disorder, obesity and diabetes, metabolic dysfunction-associated steatohepatitis, stroke, alcohol use disorder, and rare diseases including Rett syndrome and Fragile X syndrome.
For more information, visit www.biomedind.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements regarding planned clinical trials, development timelines, regulatory activities, enrollment expectations, and the potential therapeutic benefits of NA-931. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Biomed Industries undertakes no obligation to update any forward-looking statements except as required by applicable law.
MEDIA CONTACT
For further information, please visit Biomed Industries' official website: https://www.biomedind.com
CONTACT
David Lee
Biomed Industries, Inc.
San Jose, CA 95131 USA
Tel. 800-824-5135
Email: media@biomedind.com
https://www.biomedind.com
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