Invion Limited Shows Off Positive Phase 2 Data for Smokers Trying to Quit
January 19, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Invion Limited today announced positive interim data from its Phase II trial of the drug referred to as oral Inv102 (nadolol) in patients with chronic cough or established COPD who are trying to quit smoking but have failed multiple times previously.
The Phase II study is an on-going double-blind placebo-controlled randomized clinical trial. INV102 (nadolol) is a beta-blocker that is currently approved to treat high blood pressure and migraines. Invion is aiming to repurpose the drug to treat chronic inflammatory airway diseases, including asthma and chronic obstructive pulmonary disease (COPD).
“These results are exciting to Invion and this field of research for three primary reasons. First, we have clear and clinically meaningful separation between subjects treated with nadolol versus placebo in four areas of biomarker investigation,” Mitchell Glass, executive vice president of research and development and chief medical officer of Invion, said in a statement. “Second, the pattern of individual neutrophil changes from visit 6 to visit 7 indicates a response to nadolol treatment.” The third reason involves data about specific extracellular-signal-regulated kinases, or ERK1/2, that seem to confirm the company’s “hypothesis concerning the unique mechanism of action of nadolol.”
The interim results were gleaned from about 30 patients out of trial that will eventually include 136 patients, Invion Chief Executive Greg Collier today told Australia’s The Courier-Mail. The company expects headline results in May or June of 2015, Blake said.
The Courier-Mail noted that these interim results were announced one quarter later than Invion expected and that their recruitment for the phase II trial is also behind the estimated schedule.
“We recognize that we must interpret these results with caution, given their interim nature, the sample size, and the variability that naturally occurs in sputum analysis,” Glass said. “However the results support our hypothesis regarding the clinical, regulatory and commercial potential of INV102 (nadolol), and also provide a strong foundation to our inhaled INV102 program, which is approaching a major development milestone.”
David Blake, an analyst for Bioshares, an Australian biotech investment research firm, also spoke to The Courier-Mail. He explained that though the results showed a possible chemical effect in patients who took nadolol, “the trial’s endpoint of a reduction in the number of cigarettes smoked is what counts.” He urged investors to be cautious. “Investors simply have to wait for the final data on this trial, the timing of which is still an unknown,” Blake said.