InKine Pharmaceutical Co. Inc. said its pre-colonoscopy bowel-cleansing drug, INKP-102, met or exceeded endpoints in a Phase III trial compared to the company's marketed purgative product, Visicol.
Results of the 706-patient trial, along with data from the Phase I and II studies, will be included in a new drug application the company expects to submit before the second half of the year. Pending approval, the sodium phosphate INKP-102 tablets eventually would replace Visicol, which InKine now is studying as a treatment for chronic constipation.
The multicenter, randomized, investigator-blinded study compared INKP-102 vs. Visicol in three groups of patients who underwent colonoscopy. One group received 32 tablets, a low dose of INKP-102, while another group received 40 tablets, a comparative dose. The third group received the FDA-approved dose of 40 Visicol tablets.
"As we believed, the data demonstrated that INKP-102, even at a lower dose, fundamentally cleansed the colon better than Visicol," said Leonard Jacob, chairman and CEO of the Blue Bell, Pa.-based company, adding that results showed INKP-102 was superior to the marketed drug in cleansing the ascending colon, what he called the "most difficult part" of the organ to clean.
More than 94 percent of patients in each study arm were responders, receiving a cleansing rating of "excellent" or "good" on a 4-point scale, and the primary efficacy analysis showed there was no inferiority of INKP-102 to Visicol. In secondary endpoints, the product was statistically superior to Visicol, with less material retained in the ascending colon, particularly the microcrystalline cellulose (MCC) residue.
Visicol's formulation includes MCC, which serves as a tablet binder. However, MCC is not soluble and leaves a residue that has to be removed prior to the procedure, Jacob told BioWorld Today.
"Gastroenterologists can do between 10 and 15 colonoscopies per day," he said. "Therefore, anything they perceive as a residue in the colon, which requires a little bit more suctioning, may be viewed as a negative."
The INKP-102 formulation "does not contain any MCC whatsoever, and is totally water soluble," he added.
When the company received marketing approval for Visicol in 2001, it was better tolerated than its liquid competitors, Jacob said. Liquid purgatives given to pre-colonoscopy patients all "have a common denominator: They taste terrible," Jacob said, adding that patients prefer Visicol 9-to-1 because the tasteless tablets can be swallowed with any clear liquid.
Jacob said patients tolerate Visicol better, and there are "fewer call backs to doctors" with nausea and vomiting complaints.
With INKP-102, InKine maintained the tolerability level, while creating a formulation that provided a benefit for doctors, as well, Jacob said. In addition to its water solubility, INKP-102 also was developed in smaller tablets with waxy coats, making them easier to ingest.
"The bottom line is, we have produced what we think is a really fabulous product," he said. "Hopefully, the FDA will feel the same."
Jacob said analysts projected about $20 million in revenues for Visicol, or about 15 percent of the market, in 2004. Considering the data reported in the recent Phase III trial, InKine hopes that INKP-102 could possibly reach about 50 percent of the market. The company has a sales force of 50 representatives and five district sales managers to launch the product upon FDA approval.
Visicol will remain on the market to provide an "orderly transition" to INKP-102, but it ultimately would be replaced by the newer formulation, Jacob said, though he added the product was in trials for low-dose use in constipation.
Along with Visicol, InKine has another marketed product, IB-STAT, an oral spray formulation of hyoscyamine sulfate for irritable bowel syndrome in adult women and for reducing bowel motility during certain diagnostic procedures. Jacob said the company is "actively looking for a product and late-development stage opportunities" and "reviewing in-licensing opportunities" to build up its pipeline for gastrointestinal disorders.
InKine has a cash position of about $13 million, and the company expects to release fourth-quarter and year-end earnings today. As of Sept. 30, the company reported revenues of $6.1 million for the quarter and about $16 million for the nine-month period. Net profit for the third quarter was reported at $1.4 million.
Shares of InKine (NASDAQ:INKP) fell 13 cents Tuesday to close at $3.90.