IntelGenx has completed a pilot study of a new oral film, INT0022, developed using company's proprietary VersaFilm drug delivery technology that is bioequivalent to a anti-psychotic.
The pilot study was designed to determine whether INT0022 is bioequivalent to an anti-psychotic product as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC).
The study results indicate that INT0022 falls within the range of bioequivalency for both Cmax and AUC and allow IntelGenx to advance the product to the pivotal bioequivalency study.
IntelGenx president and CEO Horst Zerbe said they have successfully demonstrated bioequivalence in humans with three different thin film products, giving IntelGenx what they believe is one of the deepest thin film pipelines in the pharmaceutical industry.
"Furthermore, our thin films are engineered to reduce drug exposure in the gastrointestinal tract, which could be a substantial benefit in minimizing certain GI related side effects that are frequently associated with anti-psychotic medicines. We will be exploring this and other potential benefits in our upcoming pivotal study," Zerbe said.
The company plans to commence scale-up and manufacturing of the pivotal batches required to support a pivotal clinical study and a future regulatory 505(b)(2) filing.