HK inno.N is speeding up the launch of a "low-capacity K-CAB tablet," which reduced capacity compared to existing K-cap tablets.

The company said Wednesday that it would release "K-CAB tablet 25mg,” which halved the capacity of K-CAB tablet 50mg, next year.

K-CAB (tegoprazan) is a new potassium competitive acid blocker (P-CAB) developed by HK inno.N, to treat gastroesophageal reflux disease and has obtained indications for erosive gastroesophageal reflux disease, non-erosive gastroesophageal reflux disease, gastric ulcer, and Helicobacter pylori eradication in combination with antibiotics.

In July, it won approval for K-CAB tablet 25mg from the Ministry of Food and Drug Safety and secured an indication for “maintenance therapy after treatment of erosive gastroesophageal reflux disease (GERD)." Upon securing the indication for maintenance therapy, the company said it has created a foundation for using K-CAB throughout the entire stage of this drug, from treatment to efficacy maintenance.

However, this indication is limited to K-CAB tablets 25mg, not the existing K-CAB tablet 50mg. Therefore, industry sources say that HK inno.N is eager to launch a low-dose K-CAB tablet to preempt the prescription of the maintenance therapy market.

For similar reasons, Daewoong Pharmaceutical, which developed another homegrown P-CAB treatment, Fexuclu (fexuprazan hydrochloride), is also conducting a phase 3 clinical trial to secure the indication for the post-treatment maintenance therapy of erosive GERD.

HK inno.N started protecting patent rights before the launch of low-capacity K-CAB tablets. According to the drug information portal Safe Medicine Nation, the company registered two patents related to the K-CAB tablet 25mg on the drug patent list on Tuesday. One is for materials and uses, and the other is for crystalline and manufacturing methods.

Accordingly, the patent for “chromaine-substituted benzimidazole and its use as an acid pump inhibitor” will be protected until Aug. 25, 2031, and the patent for "new crystalline form of benzimidazole derivatives and their preparation methods" will be protected until March 12, 2036.

HK inno. N also presented the results of the phase 3 clinical trial of post-treatment maintenance therapy attend the United European Gastroenterology Week (UEGW) 2022) in Austria from Oct. 8-11.

The phase 3 clinical trial of post-treatment maintenance therapy was conducted on 351 people confirmed to have cured erosive GERD in Korea. The company stressed that as a result of administering K-CAB tablet 25mg for up to six months to prevent the recurrence of GERD, it had confirmed not just its maintenance of effectiveness but safety in long-term use.

In particular, the company explained that the tablet showed superior effectiveness in the maintenance therapy for patients with moderate or higher levels compared to the PPI administration group and demonstrated similar effects regardless of the specific genotype CYP2C19.

"We are conducting various differentiating clinical studies on K-CAB aside from trials to expand its indications. In addition, we will publish a paper on its maintenance therapy effectiveness in SCI-class international journals soon," said Song Keun-seok, managing director for R&D. “Starting with the release of K-CAB's latest research results at a large European conference, we will accelerate its global territorial expansion.