Invion completes enrolment in INV102 trial

Invion (ASX:IVX) has completed recruitment in a phase IIb trial of INV102 in patients with chronic bronchitis or COPD who are trying to quit smoking but have failed multiple times.

The randomised, double-blind, placebo-controlled trial is designed to examine the efficacy of INV102 (nadolol) on smoking cessation over a 10- to 12-week treatment period.

Interim results released last month show that nearly all patients to date have tolerated titration to a maintenance dose and have remained enrolled in a smoking cessation program.

Patients receiving INV102 have demonstrated clinically relevant changes in four biomarkers of inflammation - IL-8, ERK2, MUC 1 and neutrophil count.

Invion CMO Dr Mitchell Glass said the interim results were exciting for three main reasons.

“First, we have clear and clinically meaningful separation between subjects treated with nadolol versus placebo in four areas of biomarket investigation. Second, the pattern of individual neutropil changes from visit 6 to visit 7 indicates a response to nadolol,” he said.

“Third, ERK1/2 is a hallmark of the beta arrestin pathway, the blockade of which is central to our hypothesis concerning the unique mechanism of action of nadolol.”

On the strength of the interim result, Morgans Stockbroking has reaffirmed its “add” rating on Invion shares, with a price target of $0.12.

During the first half of the year, Invion is expected to release phase II data from the trial, as well as a separate trial of INV103 in lupus, and complete enrolment of an NIH-funded phase II trial of INV102 in people with asthma.

The company is also expected to hold a pre-IND meeting for INV102 as a potential therapy for asthma, COPD and cystic fibrosis. Positive results in these and other milestones would help the company meet its price target, Morgans said.

Invion (ASX:IVX) shares were trading 2.08% lower at $0.047 as of around 1 pm on Thursday.

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