Santhera & ReveraGen dose first patient in Phase 2 Vamorolone study
Category: #health  By Saipriya Iyer  Date: 2022-08-22
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Santhera & ReveraGen dose first patient in Phase 2 Vamorolone study

Switzerland-based Santhera Pharmaceuticals, and US-based ReveraGen BioPharma, Inc, have reportedly announced that they have dosed the first patient in the Phase 2 pilot study of vamorolone, their new drug candidate, to assess its effectiveness in treating in Becker muscular dystrophy or BMD.

As per reports, the study is being funded through a $1.2 million grant, that was awarded to the firms by the US FDA under one of its leading grants program geared towards clinical trials of orphan products that addressing the unmet needs of a rare diseases.

Supposedly, the grant further adds to existing grants the enterprises have received from the NIH (National Institutes of Health), more specifically the Arthritis, Musculoskeletal and Skin Diseases division known as ‘NIAMS’, as well as the Foundation to Eradicate Duchenne.

The Phase 2 pilot clinical trial is a placebo-controlled, double-blind, randomized study designed to evaluate the tolerability, safety, as well as the exploratory clinical efficacy of vamorolone on motor function outcomes in comparison to placebo over a duration of 24 weeks.

The study participants would entail 39 males, between the ages of 18 and 65, suffering from BMD. The participants would be randomized in a ration f 2:1 to vamorolone 500 mg per day or placebo.

According to the announcement, the clinical study plans on enrolling at sites in Padova (Italy) and Pittsburgh (USA).

ReveraGen BioPharma President and CEO, Eric Hoffman, PhD, stated that currently there are no approved drugs or treatments for BMD in the world, with no drugs candidates in clinical development for the indication in Europe or the USA.

Hoffman added that Vamorolone has demonstrated its efficacy in the VISION-DMD trial in regard to Duchenne Muscular Dystrophy or DMD, which is a more severe related disease to BMD, and, on the basis of these findings as well as the candidate’s mechanisms of action, it is expected that the proposed developmental compound might prove beneficial in BMD as well.

For the uninitiated, BMD, which is the second most common type of disease that causes progressive muscle wasting, is similar to, but milder than DMD. The ailment is caused by the very same dystrophin gene as DMD, (allelic) mutations, but showing residual dystrophin protein within the muscle, as well as variable onset and progression of the weakening of the muscle.

Source credit: https://www.globenewswire.com/news-release/2022/08/22/2501855/0/en/Santhera-and-ReveraGen-Announce-First-Participant-Dosed-in-FDA-funded-Phase-2-Pilot-Study-with-Vamorolone-in-Becker-Muscular-Dystrophy.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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