InKine Announces Positive Phase III Study Results of INKP-102

InKine Pharmaceutical has announced positive results of the company's multicenter, Phase III study of its next generation sodium phosphate tablet, INKP-102.

The recently completed, randomized, investigator-blinded noninferiority study included 706 adults who underwent colonoscopy. Patients received either 32 tablets (reduced dose) or 40 tablets (comparator dose) of INKP-102 or the FDA-approved dose of 40 Visicol tablets. Both of the INKP-102 arms utilized a dosing schedule that was of shorter duration, more convenient, and less complicated than the Visicol dosing regimen.

Approximately 25 percent of patients in the study were at least 65 years old and the study population included slightly more women than men and included all major U.S. ethnic groups. More than 94 percent of patients in each study arm were responders. A responder was a patient who received an overall colon cleansing rating (the study protocol's specified primary endpoint) of "excellent" or "good" on a four-point scale.

The primary efficacy analysis convincingly demonstrated noninferiority of both INKP-102 dose regimens to Visicol. For all of the protocol-specified secondary efficacy endpoints, INKP-102 was significantly superior or comparable to Visicol. In the ascending colon, where retained material such as stool and MCC is most often seen, each INKP-102 arm was statistically superior to Visicol for all tested endpoints.

During a colonoscopy, physicians use water to irrigate (wash away) retained material in the colon, including stool and MCC. Both of the INKP-102 doses were statistically superior to Visicol in terms of the amount of irrigation fluid used during the colonoscopy procedure, another indication of the cleansing superiority of INKP-102. There were no statistically significant differences in any of the efficacy-associated endpoints between the two INKP-102 arms.