Prometic’s state of the art technologies and products are embedded into a successfully scaled-up manufacturing process for the development, manufacturing and commercialization of best in class plasma-derived therapeutics. Prometic’s proprietary and proven affinity adsorbents are incorporated in a downstream, multi-sequential chromatographic process to extract, isolate and purify high-value proteins with superior yield and efficiency from what is currently available from the industry. The process also incorporates viral inactivation as well as prion reduction that surpass the industry alcohol based extraction process. The gentle process provides for significantly better yield and economic benefits and is easily adaptable to different protein market needs.
Plasma-derived therapeutics indications currently being pursued:
Plasminogen (plasminogen deficiency):
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
Prevalence of severe HPG is in the range of 1.6/1,000,000 for severe hypoplasminogenemia or type 1 plasminogen deficiency.
Prometic has completed its pivotal Phase 2/3 clinical trial in patients with plasminogen deficiency which has met its primary and secondary endpoints with the intravenous plasminogen treatment.
In addition to being safe, well tolerated and without any drug related serious adverse events, Prometic’s plasminogen treatment achieved a 100% success rate of its primary end point, namely, a targeted increase in the blood plasma concentration level of plasminogen as a surrogate target. Moreover, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment, a 100% response rate for this secondary end point.
Following the pre-BLA meeting recently held with the Food and Drug Administration (“FDA”), it was agreed that Prometic would continue along the Accelerated Approval Regulatory Pathway and file the pharmacokinetic safety data on 10 plasminogen deficient patients along with efficacy data available for each of these patients that have completed 12 weeks of treatment.
In addition to the 100% response rate observed with the patients currently enrolled in the pivotal Phase 2/3 trial, Prometic also generated similar data on 3 patients treated under a compassionate use program in the USA and in Germany. The USA Phase 2/3 study was also extended to include patients in Norway. All these patients will contribute to the pharmacokinetic, safety, and efficacy databases.
Prometic has started to file the various BLA modules and anticipates commercially launching its plasminogen product during the second half of 2017
Plasminogen wound healing:
A diabetic foot ulcer is an open sore or wound that is commonly located on the bottom of the foot. Native Americans, African Americans, Hispanics, and older men are more likely to develop ulcers. People who use insulin are at higher risk of developing a foot ulcer, as are patients with diabetes-related kidney, eye, and heart disease. Being overweight and consumption of alcohol and tobacco also play a role in the development of foot ulcers. Ulcers form due to a combination of factors, such as lack of feeling in the foot, poor circulation, foot deformities, irritation and trauma, as well as duration of diabetes. Patients who have diabetes for many years can develop neuropathy, a reduced or complete lack of ability to feel pain in the feet due to nerve damage caused by elevated blood glucose levels over time. Vascular disease can complicate a foot ulcer, reducing the body’s ability to heal and increasing the risk for an infection. Elevations in blood glucose can reduce the body’s ability to fight off a potential infection and also slow healing.
Diabetic wounds affect more than 2 million patients in North America and necessitate an estimated 100,000 amputations annually in the USA alone.
The upcoming wound healing clinical program is expected to commence in H1 2017.