Convergence Posts Positive Phase 2 Results For Orphan Drug In TGN

Convergence Pharmaceuticals Holdings reported positive data from the Phase II clinical trial of its orphan drug CNV1014802 in patients with trigeminal neuralgia (TGN), a very severe form of facial pain.

CNV1014802 is a novel small molecule state-dependent sodium channel blocker that has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in July last year. In the trial, the investigational drug achieved a 55 percent decrease in pain severity compared to 18 percent for placebo. Results also showed that CNV1014802 achieved a 60 percent average reduction in the number of recorded paroxysms versus 12 percent in the placebo group.

Clive Dix, CEO of Convergence, said, “We are delighted by the results of this study which we believe will form the cornerstone of the Convergence investment case as we look to progress the company's portfolio through to commercialization. Based on these data, we will advance CNV1014802 in to clinical studies with a wider patient population and believe that CNV1014802 will offer tremendous relief to sufferers of TGN and other chronic pain conditions."

Prof. Joanna Zakrzewska, chief study investigator, with the University College London Hospitals NHS Foundation (UCLH), said, “Having worked in the field of TGN for over 20 years and managed hundreds of patients with this severe facial pain it is wonderful news to find that there is potentially a new drug to add to our armory which not only is effective but is also so well tolerated. This is the first time that we have a drug specifically being trialed in TGN rather than using a previously developed anti-epileptic drug.”

TGN is a very severe form of facial pain that occurs in sudden, brief, stabbing, recurrent episodes on one side of the face. These episodes can be triggered by the lightest touch. TGN pain follows one or more branches of the trigeminal nerve that provides nerve sensation from the mouth, face and the front of the scalp. The condition affects an estimated 50,000 people in the U.S. alone.

The company said it will publish full study results at the International Association for the Study of Pain (IASP) World Congress of Pain, Buenos Aires in October this year.