IntraBio, baby steps for the treatment of Ataxia-Telangiectasia

Introduction

IntraBio Inc. operates in the healthy air of Austin, Texas, with its innovative treatment development for common and rare neurodegenerative conditions. The company sharpens its smartness from Munich and the University of Oxford with its delivery of essential products to the calcium building and lysosomal function. IntraBio’s comprehensive products are effective as they are tested and qualified under platform technologies monitoring. The company is grounded in science-based solutions and impeccable marketing experience.

Announcement

IntraBio Inc. proudly declared its positive Phase 3 IB1001-303 clinical trial results. The clinical trial is titled ‘Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A Randomised, Placebo-Controlled, Double-Blind, Crossover Study’. This study assesses N-acetyl-L-leucine (levacetylleucine) in the Ataxia-Telangiectasia (A-T) condition in adult and underage patient cohorts.

Recap of the Phase 3 IB1001-303 clinical trial

The first stage of this trial was to assess the response/reaction of the treatment with levacetylleucine as per the Scale for the Assessment and Rating of Ataxia (SARA) against the placebo one after 12 weeks of the treatment flow. Learning from this evaluation, the treatment with levacetylleucine illustrated that the treatment is clinically worthy, noting a 1.88 improvement under SARA grades.

The second stage illustrated the clinical proven effective perfection under Investigator’s Clinical Global Impression of Improvement (CGI-I) and International Cooperative Ataxia Rating Scale (ICARS). In this stage, levacetylleucine was detected to be tolerable and safe with no such negative side effects recorded in drug usage.

IntraBio is now more confident with this result and will quickly envelope submissions at the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) desk and other mandated global regulatory authorities.

Massachusetts General, Investigator of the IB1001-303 study, Dr Franziska Hoche, said, “This is an innovation and relief to the families and patients suffering from Ataxia-Telangiectasia, as A-T is a rare and destructive condition with no qualified treatments as of now. These positive results will bring positive change to the patients’ day-to-day function and neurological system. This is a crucial clinical and scientific profit with a proven state of levacetylleucine potency that will make a good impact on the A-T patients' quality lives.”

Levacetylleucine’s presence and contribution in Europe and the United States are creating pure magic in patients' lives and in late-stage development. The Founder of the A-T Children’s Project, Brad Margus, also expressed his view and satisfaction towards these results and how it’s a ray of hope for Ataxia-Telangiectasia patients and their families.