Intelgenx ED results positive

IntelGenx (TSX-V:IGX) has completed a pilot study that indicates its oral film, INT007, is bioequivalent to a leading branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction.

“This is the second VersaFilm project that we progressed into the clinic, and the second VersaFilm project that has yielded positive bioequivalence results,” CEO Dr. Horst Zerbe said in a statement. “Furthermore, this study has demonstrated not only bioequivalence but also a faster onset of action, which could be another advantage versus the current tablet formulation.”

The company now plans to begin scale-up and manufacturing of the pivotal batches required to support a pivotal clinical study and future regulatory 505(b)(2) filing.