In February 2020, Apabetalone became the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation, for a major cardiovascular indication, to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
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I’m Katriina Cotten for Investmentpitch Media
Resverlogix Corp. reported that its Apabetalone drug met its primary endpoint in a pulmonary arterial hypertension or ‘PAH’ investigator led pilot study.
Resverlogix, a world leader in epigenetics, or gene regulation, has been pioneering a technology which has the ability to turn multiple disease genes on or off, without changing the human DNA.
While most of us know that we inherit our genes via DNA, few of us realize the activity of these genes is determined by epigenetics, which literally means “on top of” genetics.
Epigenetics has become an exciting forefront for the discovery of new medicines, such as Apabetalone, an advanced cardiovascular drug being developed by Resverlogix.
In February 2020, Apabetalone became the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation, for a major cardiovascular indication, to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
Apabetalone is a first-in-class, small molecule that is a selective bromodomain and extra-terminal, or BET, inhibitor, an epigenetic mechanism that can regulate disease-causing genes.
Apabetalone selectively targets the second bromodomain or ‘BD2’ within the BET proteins, producing a specific set of biological effects with potentially important benefits for patients with COVID-19, high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
The prevalence of BET proteins in the human body allows apabetalone to simultaneously target multiple disease-causing biological processes, leading a new paradigm shift in the treatment of chronic disease.
Dr. Steeve Provencher, Director of Pulmonary Research, Institute of Cardiology and Respirology of Quebec, Laval University and the lead investigator and sponsor of the trial, stated: “The study successfully achieved its primary objective of confirming the feasibility of the clinical study design and demonstrated encouraging results of apabetalone treatment in patients with PAH. This strongly sets the ground for the planned larger double-blind study.”
This initial APPROACH-p trial was limited to patients diagnosed with pulmonary arterial hypertension of idiopathic/hereditary origin or associated with connective tissue disease.
All patients received oral apabetalone twice-daily for 16 weeks, alongside existing standard of care treatments.
Among the key findings, it was reported the treatment was well tolerated with all patients and the treatment improved key hemodynamic variables on top of standard of care treatment, thereby improving the quality of life for the participants.
The encouraging results of this study pave the way for the larger multi-centered APPROACH-2 trial, a phase 2, randomized, placebo-controlled study of apabetalone for the treatment of pulmonary arterial hypertension, which is expected to begin enrolling patients later this year.
The shares are trading at $0.67.
For a more in depth explanation of this technology and this study, please refer to the company’s news release, its website, www.resverlogix.com, or contact the company at 403-254-9252 or by email at ir@resverlogix.com.
I’m Katriina Cotten for Investmentpitch Media
