Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

• Examination of sub-population data, with patient stratification, demonstrated promising results, despite interim analysis on the entire patient cohort not revealing significant differences between the RESCAP® and placebo groups for all endpoints

• Specifically, among patients with a normal renal filtration rate before cardiothoracic surgery, those who received RESCAP® achieved hemodynamic stability 30% sooner and experienced a 70% reduced likelihood of post-surgery acute kidney injury

• Follow-up Phase III Study with RESCAP® to commence in Q3 2023, with anticipated further accelerated recovery and reduced other complications for all enrolled patients, due to longer administration

• RESCAP® has the potential to significantly change the approach to critical care in the perioperative periods of major surgeries, resulting in reduced healthcare costs and enabling patients to recover and resume their lives more quickly

Wageningen, the Netherlands, 24 August 2023 - Alloksys Life Sciences, a clinical stage biotech company specializing in the development of critical care medicines, today announced interim results from its APPIRED-III study. The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery. The results demonstrate a substantial decrease of around 30% (p < 0.001) in the duration needed to achieve stable blood flow or hemodynamic stability in patients with a normal renal filtration rate before surgery (CKD ≤ 2) who were administered RESCAP® compared to placebo. Moreover, RESCAP® exhibited a 70% reduced probability (p < 0.05) of post-surgical acute kidney injury in these patients.

The prospective, randomized, double-blind, and placebo-controlled study was conducted in multiple centers in Europe and the Asia/Pacific region. The subgroup with a normal renal filtration rate that clearly benefited from RESCAP® administration, constituted approximately 50% of the total cohort. These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023.

Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery. He stated:

"We are encouraged that the interim results of our APPIRED-III study demonstrate a positive impact of RESCAP® on recovery of a subgroup of patients. Based on these findings, we anticipate that by extending the administration of RESCAP® in the planned phase III follow-up trial, it will also prove to be effective for patients with more severe chronic kidney disease before surgery. We firmly believe that the RESCAP® intervention has the potential to really impact critical care practices during and after major surgeries. The ability of RESCAP® to expedite recovery may prove to be a major breakthrough in critical care applications.”

APPIRED III trial

APPIRED III is a prospective, randomized, double-blind, and placebo-controlled study involving patients undergoing cardiopulmonary bypass-supported heart surgery, conducted in multiple centers across Europe and the Asia/Pacific region. Prior to surgery, patients received a bolus of 1000 IU of RESCAP® or placebo, followed by a 24-hour infusion with 9,000 IU or placebo.

The primary aim of the study was to compare the mortality, morbidity and complications between the administration of alkaline phosphatase versus placebo, with the primary composite endpoint being to demonstrate a reduction in the incidence and extent of acute kidney injury (AKI) after cardiothoracic surgery. While these endpoints were not found for the total patient cohort in this phase IIb trial, the subgroup of patients with normal renal filtration rate did show the aimed for reduction in AKI.

Upcoming Phase III trial and market access

Alloksys anticipates that in the upcoming phase III trial, with longer administration of RESCAP® (up to 96 hours), benefits such as accelerated recovery and reduced acute kidney injury is expected in all patients (CKD ≤ 3) to be enrolled, further confirming the results of the phase IIb trial. After conducting the planned phase III trial, of which enrollment is expected to commence in Q3 2023, Alloksys plans, preferably with a strategic partner, to prepare a New Drug Application (NDA) and/or Marketing Authorization Application (MAA) for RESCAP® in the US and/or EEA, followed by introduction to the market as a critical care medicine.

Substantial demand for effective critical care therapies

The multi-billion-dollar critical care medicine market relevant for Alloksys’ RESCAP® solution, is a vital and fast-growing segment of the global healthcare industry, focused on diagnosing and managing life-threatening illnesses and injuries. This specialized branch of medicine deals with critical cases, including (septic) shock, burns, accidents, complex (e.g. cardiothoracic) surgeries, sepsis, and severe respiratory problems. The treatment is usually administered in extreme costly intensive care units (ICUs) or trauma centers, where patients receive round-the-clock monitoring and specialized medical attention. These therapies are essential in stabilizing patients, managing symptoms, and improving overall outcomes in critical care situations.

The prevalence of conditions like sepsis and acute respiratory distress syndrome has been increasing, especially in older adults and patients with compromised immune systems or chronic health conditions. This escalation in critical illnesses has created a substantial demand for effective pharmaceutical therapeutics that can address these life-threatening medical emergencies.

Additionally, the aging global population is a key demographic factor impacting the market. The elderly population is more susceptible to critical illnesses, and their growing numbers have heightened the need for specialized medications tailored to their unique healthcare requirements. As the proportion of older adults increases worldwide, the demand for critical care pharmaceutical therapeutics is expected to grow significantly.

Moreover, advancements in medical research and technology have contributed to the development of innovative therapeutics. These advancements, like RESCAP® by Alloksys, could further lead to improved patient wellbeing following major surgery due to improved treatment outcomes and ultimately in reductions in healthcare costs.

RESCAP®

RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP). AP is naturally present in the body and plays a role in the innate immune system, acting as a "first line of defense." The medication targets and neutralizes circulating inflammation-triggering moieties (ITMs), reducing overall inflammation in the body. By modulating the inflammatory response and supporting native alkaline phosphatase activity at membrane barriers, RESCAP® helps maintain tissue integrity and function, promoting faster recovery.

Thus, RESCAP® holds promise as a potential therapeutic agent for various inflammatory conditions and critical care settings.

RESCAP® is derived from calf intestines and has been demonstrated to be safe and suitable for intravenous administration in humans. Alloksys has a secured supply of bovine intestinal alkaline phosphatase, which can be scaled up for production.