'2 Round' Gastroesophageal Reflux Disease Treatment... Now Expanding Indications

'P-CAB' Agents Emerging as Alternatives to Existing PPIs
Latecomer Daewoong's 'Pexuclu' Secures Indication for Gastritis
Leader Innoen's 'K-CAB' Already Approved for Multiple Indications

Market Size Still Larger for PPIs
Attention on Whether P-CAB Growth Will Continue

Daewoong Pharmaceutical's potassium-competitive acid blocker (P-CAB) gastroesophageal reflux disease treatment 'Pexuclu'

[Asia Economy Reporter Lee Chun-hee] Competition in the market for potassium-competitive acid blockers (P-CAB), a new mechanism emerging for the treatment of gastroesophageal reflux disease (GERD), is accelerating. While HK Innoen's 'K-CAB' quickly secured the market, Daewoong Pharmaceutical's 'Pexuclu,' a latecomer, is increasing its speed to overtake by adding indications that K-CAB has not yet secured.

According to the industry on the 23rd, Daewoong Pharmaceutical recently received approval from the Ministry of Food and Drug Safety for the indication of Pexuclu 10 mg to improve gastric mucosal lesions in acute and chronic gastritis. This indication for gastritis is the first approval among P-CAB formulations in Korea, and actual prescriptions are expected around December. With this, Pexuclu has secured two additional indications in addition to the existing erosive GERD treatment (40 mg).

To add the gastritis indication, Daewoong Pharmaceutical conducted efficacy and safety evaluations on 300 adult men and women from May 2020 to August last year. As a result, in the efficacy evaluation indicator ‘efficacy rate of gastric mucosal erosion in upper gastrointestinal endoscopy,’ both 20 mg tablet once daily (59/102 patients, 57.8%) and 10 mg tablet twice daily (67/102 patients, 65.7%) showed superiority compared to the placebo group (39/96 patients, 40.6%), confirming the therapeutic effect on gastritis. In the safety evaluation, there was no statistically significant difference between groups in the incidence of adverse reactions and drug-related adverse reactions. No serious adverse reactions or drug-related adverse reactions occurred, confirming it as a safe drug.

Daewoong Pharmaceutical is not stopping there and plans to continuously expand indications while adding formulations. Regarding indications, phase 3 clinical trials are underway to add maintenance therapy after erosive GERD treatment and prevention of ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical trials for Helicobacter pylori eradication therapy are also being prepared. In terms of formulations, expansion of the lineup through the development of orally disintegrating tablets and intravenous (IV) formulations is also underway.

'K-CAB' widening the gap... Can P-CAB formulations surpass PPIs?

HK Innoen 'K-Cab Tablet' (Photo by HK Innoen)

K-CAB, which has established itself as the leader in the domestic P-CAB market, also plans to expand indications further to shake off pursuers. K-CAB has already secured 3 of the 5 total indications currently targeted by Pexuclu (erosive GERD, maintenance therapy after erosive GERD treatment, and Helicobacter pylori eradication). In addition, it holds a total of 5 indications including non-erosive GERD and gastric ulcers. In terms of formulation, orally disintegrating tablets have already been launched.

HK Innoen is also conducting phase 3 clinical trials to add the indication for prevention of NSAIDs-induced gastric and duodenal ulcers. The goal is to recruit 390 patients and complete the trial within this year.

Jeil Pharmaceutical, developing 'JP-1366' through its subsidiary Onconic Therapeutics, is also striving to secure additional indications beyond the initially targeted erosive GERD. Following the phase 3 clinical trial for erosive esophagitis that began in December last year, it received approval from the Ministry of Food and Drug Safety in May for a phase 3 clinical trial targeting gastric ulcer patients.

This situation is due to the advantages of P-CAB formulations over the previously mainly used proton pump inhibitors (PPIs) for GERD treatment becoming prominent, causing a paradigm shift in the market. PPI formulations must be taken 30 minutes before meals and have the inconvenience of acid secretion occurring at night due to stimulation of acid secretion. Side effects such as osteoporosis and stroke have also been controversial. However, P-CAB formulations can be taken regardless of meal times and have improved nighttime heartburn.

However, the market is still dominated by PPIs. According to the pharmaceutical market research firm Ubist, the combined prescription dispensing amount for PPI drugs such as 'Esomazol' (Hanmi Pharmaceutical), 'Noltec' (Ilyang Pharmaceutical), 'Nexium' (AstraZeneca), and 'Lanston' (Takeda) reached 117 billion KRW in the first half of this year. However, K-CAB's prescription dispensing amount grew rapidly by 21.1% from 50 billion KRW in the same period last year to 60.6 billion KRW, and Pexuclu recorded about 1.1 billion KRW in outpatient prescriptions within one month after its launch on the 1st of last month, accelerating market entry and showing rapid growth in the P-CAB market as well.

This content was produced with the assistance of AI translation services.