Corbus to Give Update on Phase 2 Study of Resunab at CF Summit

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by Patrícia Silva, PhD |

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Trikafta, Cystic Fibrosis Foundation

Corbus Pharmaceuticals announced that its CEO will give an update on clinical work and anticipated milestones for Resunab (JBT-101), the company’s synthetic oral drug designed to resolve chronic inflammation and fibrosis, at the upcoming Jefferies Cystic Fibrosis Summit. The treatment is under evaluation in three Phase 2 clinical trials.

Last year, Corbus received a $5 million development award from the Cystic Fibrosis Foundation to move its investigational cystic fibrosis (CF) treatment into testing in patients. Recently, the company announced it has completed patient enrollment in a Phase 2 multicenter, double-blinded, and placebo-control clinical trial (NCT02465450) evaluating the safety, tolerability, pharmacokinetics and efficacy of different doses of Resunab in CF patients. Corbus expects to report top-line results early next year.

Yuval Cohen, PhD, Corbus’ chief executive officer, will deliver the update presentation at the summit, taking place in New York on Thursday, Sept. 29, according to a Corbus press release. The presentation will begin at 1:15 p.m. ET.

Resunab is a synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor in activated immune cells and fibroblasts. It is thought to work by affecting fibroblasts directly, in order to stop tissue scarring (fibrosis). The drug triggers endogenous pathways (through CB2 activation) to turn ‘off’ chronic inflammation and fibrotic processes without causing immunosuppression.

“Inflammation causes lung damage in CF, and none of the approved treatments for CF directly address this aspect of the disease. By activating the resolution phase of inflammation, Resunab has the potential to provide a clinical benefit not being offered by the current medications for CF,” James Chmiel, MD, a professor of Pediatrics at Case Western Reserve University and associate director of the LeRoy W. Matthews Cystic Fibrosis Center in Cleveland, who is the principal investigator for the U.S. part of the trial, said in an earlier press release announcing the completion of patient enrollment in the Phase 2 trial. The study is taking place at numerous sites in the U.S. and Europe.

Preclinical and Phase 1 studies have demonstrated that Resunab has a favorable safety, tolerability and pharmacokinetic profile, as well as promising effects in preclinical models of inflammation and fibrosis.

Resunab is also being evaluated in clinical studies in diffuse cutaneous systemic sclerosis (NCT02465437), and diffuse cutaneous and skin-predominant dermatomyositis (NCT02466243).