Cinclus Pharma raises SEK 250 million


March 4 2020


Cinclus Pharma raises SEK 250 million for the continued development of a novel treatment against gastroesophageal reflux disease

Cinclus Pharma Holding AB (“Cinclus Pharma”) announced today that the company has successfully completed a financing round of SEK 250 million to fund the further clinical development of X842 –aclinical-stagedrug candidate for the treatment ofgastroesophageal reflux disease(GERD). The Fourth Swedish National Pension Fund (AP4) joined as a new major shareholder through the issue, which was also subscribed by, among others, the current shareholders Bengt Julander, Jonas Sjögren and Recipharm Venture Fund. X842 has the potential to alleviate GERD symptoms and heal esophageal injuries more effectively than current pharmaceutical therapies. Gastroesophageal reflux disease (GERD) is a common medical condition characterized by regurgitation of gastric acid from the stomachinto the esophagus. This  can lead tosevere pain and mucosal erosions. Currently available GERD treatments are not sufficiently effective to maintain a normal esophageal pH over the course of a full day. Among patients treated with proton pump inhibitors (PPIs) such as Losec® or Nexium®, about40 percent experience unsatisfactory symptom alleviation. More than 35 percent of patients who suffer from severe esophageal erosions (grade C and D esophagitis)are not healeddespitehigh dosage treatment with PPIs.Cinclus Pharma’s drug candidate X842represents a novel class of pharmaceuticals (Potassium Competitive Acid Blockers, P-CAB), which utilizes a different mode of action to modulate and control the release of gastric acid, as compared to PPIs. This novel approach provides a better way to alleviate symptoms and promote healing of the fretted mucosal lining. X842 is based on a substance initially developed by AstraZeneca that has been proven safe and well-tolerated in studies including over 2500 individuals. Thefavorablesafety profile and pharmacokineticcharacteristicsof X842has been demonstrated in a Phase 1 clinical study. The proceeds from the financing roundwill be used to performa phase 2 clinical trial, which is expected to start in the second half of 2020, as well as operating costs and other key activities necessary to make the project ready fora pivotal phase 3 clinical trialprogram.“The high level of interest from reputedand long-term investors provides us with the opportunity to bring our unique drug candidate,X842,all the wayto a pivotal phase 3 clinical program. The introduction of Losec and other proton pump inhibitors in the 1980s and the 1990s was a major step forward in the treatment of GERD. However, there is potential to help significantly more patientsto a better lifeby developing even more efficient drugs”, says Kjell Andersson, CEOatCinclus Pharma. Cinclus Pharma estimates that a superior pharmaceutical for the treatmentofsevere esophagitis (grade C and D), and other patient groups where PPIs are not sufficiently effective, may have a blockbuster potential.

About Cinclus Pharma

The Swedish based company Cinclus Pharma Holding AB is the 100% owner of Cinclus Pharma AG, a research-based biotech company, based in Basel, Switzerland. It develops small molecules for the treatment of gastric acid related diseases. Its lead candidate, X842, has successfully completed a Phase I clinical trial. The company have an experienced management team with deep knowledge in the different aspects of drug development and business development, coming from both the multinational sector as well asthe biotech sector. The management team is highly experienced in the GI area (AstraZeneca, Glaxo and Novartis).


About GERD

Gastroesophageal reflux disease (GERD) is a digestive disorder that affects the lower esophageal sphincter (LES), the ring of muscle between the esophagus and stomach. Many people suffer from heartburn or acid regurgitation caused by GERD. About 175 million people of the adult population in North Americaand Europe suffer from reflux disease. The global acidreflux market –worth $12-14bn -is dominated by proton-pump inhibitors (PPIs). On average5-10% of eGERD Grades A and B and approximately 30% of patients with eGERD Grades C and D are unhealed after eightweeks on PPIs, and 78% of all GERD patients experience nocturnal symptoms despite PPIs -resulting in impaired quality of life. More than 20% of the all GERD patients take PPIs twice daily to overcome the incomplete symptom relief or supplement their treatment with over the counter-remedies. Despite frequent off-label prescription of high dosage PPIs, many patients still suffer from poor symptom control indicating a clear need for better drugs to treat severe or symptomatic GERD, and in particular therapies with an effect that is sustained for >24 hours.


About X842

X842 represents a novel class of drugs, Potassium Competitive Acid Blocker (P-CAB), and is a fast-acting regulator of intragastric pH by a different mechanism of action than PPIs. X842 belongs to the P-CAB class that competitively inhibits the H+, K+-ATPase in the parietal cell and thereby controls gastric acid secretion. X842 is a prodrug of linaprazan, with comprehensive data from 25 Phase I studies including more than 600 subjects. Furthermore, two Phase II studies including 2,973 patients showed that linaprazan was well tolerated, with a fast onset of action and full effect at first dose. However, linaprazan was quickly eliminated from the body and had too short duration of acid inhibition. In comparison, X842 has alonger half-life in the body, shows total control of the gastric acid production, and is tailored for patients with severe eGERD.


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