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news.Pivotal Therapeutics has started patient enrollment in its Pomega Phase IIa clinical trial with PVT-100, a formulated drug candidate.
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The trial named ‘Impact of an optimized Omega 3 formulation on the biochemical and histopathological composition of atheromatous plaques in patients to undergo carotid endarectomy’, will assess the histomorphological, biochemical and immunological status of the vascular plaque.
Pivotal focuses on Omega-3 therapies for cardiovascular (CVD) diseases (CVD).
The double-blinded placebo controlled Pomega trial will be conducted in more than 100 patients scheduled to undergo vascular invasive surgery for carotid endarterectomy at the University Hospital of Strasbourg, France.
In the trial, patients will receive either PVT-100 or a placebo, for six consecutive weeks.
Pivotal Therapeutics co-founder and chief scientific officer Dr George Jackowski said: "Positive results of the trial will allow for new indications for prescription Omega-3 formulations, initiating novel therapeutic regimes beyond treating patients with very high triglycerides."
Sponsored by the University Hospital of Strasbourg and authorized by the French national supervisory authority ANSM, the trial is coordinated by an interdisciplinary team of six vascular surgeons, 20 health professionals and monitored by the French health authorities via the national clinical trial management system (CTMS).