RNS Number : 6225E
Oxford Pharmascience Group PLC
05 November 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Successful Completion of Proof-of-Concept for OXPzeroTM Ibuprofen
Following the successful completion of the second study with OXPzeroTM Ibuprofen, the Company is pleased to announce that it has established a robust body of data which it will use to progress into partnering discussions for the application of the Company's OXPzeroTM technology to ibuprofen.
The body of data collected across the two studies demonstrate that OXPzeroTM Ibuprofen is a differentiated, superior form of ibuprofen delivering a range of benefits over the standard drug across multiple parameters. In particular, OXPzeroTM Ibuprofen has been proven to:
- deliver major reduction in the incidence and severity of gastrointestinal (GI) mucosal damage;
- completely taste mask the bitterness of ibuprofen; and
- deliver an attractive PK profile with immediate and complete drug release.
The Company believes these benefits offer major competitive advantages and strongly position OXPzeroTM Ibuprofen to become a disruptive compound in the worldwide ibuprofen market. Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector with worldwide sales of Ibuprofen in excess of $4bn per annum. The Company has initiated contact with a number of large, global pharmaceutical companies with strategic interest in the ibuprofen market and is at an advanced stage of preparing information to proceed to the commercialisation phase with the OXPzeroTM Ibuprofen asset.
Marcelo Bravo, Chief Executive Officer, commented:
"We are very pleased with the data package on OXPzeroTM Ibuprofen which demonstrates this is a compound with potential to disrupt the market, delivering a range of key benefits that provide clear and compelling differentiation. The body of data shows this is a versatile and flexible technology that can allow major brand owners to create and sustain competitive advantage in the large and growing ibuprofen market through multiple brand extension options. In the coming weeks, we will be completing preparation of commercial discussion materials with the aim of seeking a partner for the OXPzeroTM Ibuprofen platform. We look forward to updating shareholders in due course.
We continue making great progress with other key NSAIDs, namely OXPzeroTM Naproxen, OXPzeroTM Diclofenac and OXPzeroTM Aspirin and also evaluating further targets. Additional announcements will be made as appropriate."
The Company has conducted two proof-of-concept studies with OXPzeroTM Ibuprofen, each performed with average prescription doses of ibuprofen (2 x 400mg tablets three times per day i.e. 2.4g per day) in healthy subjects:
· Study 1 - OXP001-002: (performed and reported in 2014) PK and endoscopy study with a standard oral 400 mg tablet with OXPzeroTM Ibuprofen vs. Brufen® in 43 healthy subjects.
· Study 2 - OXP001-003: Two part study. Part 1 PK study in 10 healthy subjects reported in August 2015. Part 2 PK and endoscopy study in 43 healthy subjects commenced in August 2015 and now complete. Both parts of the study were performed with a chewable tablet of optimised OXPzeroTM Ibuprofen vs. Brufen®. PK assessments after single dose in Part 1. In Part 2, PK assessments were made on Days 1 and 7 with endoscopy assessments on Day 8.
Endoscopy data confirms major reduction in the incidence and severity of GI mucosal damage
Data from both studies show a consistent, positive trend for OXPzeroTM Ibuprofen through a reduction in the incidence and severity of GI mucosal damage when compared to the Brufen reference.
- OXPzeroTM Ibuprofen exhibited major reductions in the incidence of severe GI mucosal damage (Lanza score ≥3) vs Brufen® ranging from 59% in Study 1 to 36% in Study 2. These are large reductions in the "severe" end of the Lanza scale, namely subjects with over 10 erosions and/or ulcers, demonstrating a clear impact for OXPzeroTM Ibuprofen. Based on odds ratios of 0.16 and 0.43, there is 5.9 to 2.2 times greater likelihood of having Lanza ≥ 3 in the Brufen® group than in the OXPzeroTM Ibuprofen group.
- OXPzeroTM Ibuprofen reduces the odds of a higher Lanza score by approximately 50% to 80% based on odds ratios of 0.17 and 0.46.
- OXPzeroTM Ibuprofen exhibited reductions in the overall mean Lanza score by between 0.9 (p = 0.006) in Study 1 and 0.3 (p = 0.185) in Study 2.
Between Study 1 and Study 2, the comparator Brufen® arm exhibited the biggest changes in absolute levels of GI irritation, with a reduction observed in the second study compared to the first. This demonstrates the variance in these relatively small studies which accounts for the loss of statistical significance in the endoscopy endpoint measures in the second study. Endoscopy efficacy measures were comparable between the OXPzeroTM Ibuprofen products tested in both studies. Further, the lack of correlation between PK (AUC, Cmax, Tmax) and GI damage across studies and treatment groups was confirmed, indicating that the GI irritation reduction seen in Study 1 was not PK dependent, validating the reduction in GI mucosal damage results seen in study 1.
The Company is of the view that the data overall demonstrates that OXPzeroTM Ibuprofen is delivering major reduction in GI mucosal damage and presents an attractive profile for commercialisation.
Superior taste masking
The taste masking benefit of OXPzeroTM Ibuprofen was demonstrated using subject interviews with the chewable tablet of ibuprofen during Study 2. Consistent feedback was received confirming that the chewable tablets were tasteless, with little of the burn or after-taste issues associated with standard ibuprofen. 90% of subjects stated that there was no bitter taste after chewing the OXPzeroTM Ibuprofen tablets. These results highlight the ability of the OXPzeroTM technology to taste mask the ibuprofen by trapping it within the layers of the OXPzeroTM matrix until the drug is released in the stomach.
Attractive PK Profile
PK results from Study 2 show complete and rapid drug release with prolonged T1/2 (the time taken to reach half of peak concentration). PK data also show Tmax (time to reach maximum serum concentration) and AUC (Area Under the Curve or total drug exposure over time) comparable to Brufen®, confirming that OXPzeroTM Ibuprofen used in Study 2 is a product with immediate and complete drug release characteristics. While the PK profile of OXPzeroTM Ibuprofen is comparable to Brufen® on these measures, the maximum level of drug concentration in plasma (Cmax) is lower than that of Brufen®, but well within the therapeutic range.
The data also demonstrate that the release properties can be adapted and the Company believes that the OXPzeroTM platform technology offers the ability to adjust speed of release to meet specific product requirements. The Company believes this is an attractive PK profile with clinical advantage suitable for commercialisation.
* The modified Lanza Scale is a scoring system commonly used to describe the severity of damage to the upper gastro-intestinal tract. The scale in this study was: Score 0 = no damage; 1 = single erosion; 2 = 2 to 9 erosions; 3 = 10 or more erosions; 4 = ulcer. Ulcers were defined as mucosal breaks of 3mm or more demonstrating unequivocal depth.
For further information:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive
+44 20 7554 5875
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell/Jen Boorer
+44 20 7496 3000
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (Over the Counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.
NSAIDs are one of the most widely used classes of drugs, with combined annual sales in excess of $12bn and more than 30 million users worldwide consuming NSAIDs each day. Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector. Worldwide sales of Ibuprofen are in excess of $4bn per annum at manufacturers selling prices. Chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant associated healthcare costs. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used NSAID molecules, namely ibuprofen, naproxen and diclofenac for pain and inflammation and aspirin for primary and secondary prevention of cardiovascular disease.
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