Background on Amytrap Technology. Recombinant Technologies LLC [RTL], is a privately held pre-clinical stage biotechnology company. RTL has been involved in the development of novel treatments for Alzheimer's Disease. Our patented API Amytrap is an injectable and has been shown to deplete circulating amyloid associated with brain amyloid depletion and memory improvement. We have demonstrated POC in vitro and in vivo in model mice. The drug is well tolerated in rats and dogs and safe even at 50x the efficacy dose. Unlike the failed antibodies to treat AD, Amytrap is safe, easy to make and stable for long term of up to 18 months. It does not induce any untoward immune or non-immune side effects. Unlike other protein based Aβ-binding ligands, RI-peptide, due to its D-amino acid composition, is protease resistant and thus offers longer shelf life. Moreover, RI-peptide can be synthesized in large quantities under stringent quality control processes to minimize batch-to-batch variations, thus less expensive to manufacture. Due to these advantages over other Aβ-binding ligands, we propose to use RI-peptide as Aβ-binding ligand in the proposed extracorporeal Aβ removal system.
Amytrapper Device. We have recently extended Amytrap's application and designed a device called 'Amytrapper' an extracorporeal device incorporating the same API, Amytrap. We base our proposal from our previous observations: 1) that our biologic, Amytrap-1 when immobilized on a solid support binds Aβ. 2) a PEGylated form of Amytrap-1 when injected subcutaneously reduces brain Aβ burden and improves cognition in a mouse (APPSWE-Tg2546) model of Alzheimer’s Disease, suggesting that peripheral removal of Aβ by Amytrap-1 helps in improving AD symptoms. The current stage of development is at the in vitro level which have demonstrated that Amytrapper is specific for the target peptide amyloid, and does not adversely retain native serum proteins. In vivo studies to test this device in a rat model is underway. Ultimately, this system will be explored for human use, wherein plasma from AD patients is passed through Amytrapper to sequester Aβ from plasma and the flow through, which is free from Aβ, would reenter the patients’ circulation.
The target device, Amytrapper, is an extracorporeal processing system to detoxify the blood. It includes a disposable component, a column containing an inert sepharose matrix coupled to the RI- peptide(API) and a pressure-controlled pump/monitor system to push the blood and separate the plasma from blood. Plasma is pushed through Amytrapper column while the rest of the blood constituents go through a separate tubing. The plasma, free from amyloid, is mixed back with the blood cells to reenter the body. The device will be useful to deplete circulating amyloid from patients/potential patients/those predisposed to AD as a ‘sit in’ procedure just like hemodialysis. The binding efficiency of the Amytrapper matrix (containing 100 μg/ml equivalent of RI peptide) is estimated to be 30% of the anticipated theoretical binding. However, this level of amyloid binding is more than sufficient as the circulating physiological level of amyloid is substantially lower in humans. Amytrapper is the first of its kind to detoxify AD patient’s blood. We are unaware of any competing devices at present.
Third Party Evaluation. A niche assessment was performed by Foresight Science & Technology (FST, Rhode Island) for Amytrapper column which assured the validity of this approach. We have obtained a favorable commercialization assessment from FST. FST recommended a ‘go’ strategy on this drug. The recommended strategy by FST is to partner with a large player in the drug and medical device market that has the experience and resources to launch medical products. We have also improvised the Amytrapper device in the form of a medically viable catheter coated inside with our material. This catheter device will be tested for amyloid capturing in a rat model soon. We have already identified vendors who can mass produce our coating Amytrap material. We have the capability to quality control the material on a constant basis.
Commercialization Initiatives. Commercialization of the device will aim to license the technology to an established firm that can manufacture and market a medical device incorporating the technology. There are no close substitutes to treat underlying Alzheimer’s pathophysiology, only drug treatments (Aricept, Namenda etc.) to alleviate symptoms or marginally slow disease progression, making this technology a novel innovation. Experts and End-users have been gauged to identify key advantages that would be necessary to commercialize this device. Independent reports via expert third party evaluations and recommendations are available. Valuation of the technology in relation to current market size and expectations is also available.
Market Size. The estimated market size in dollars for the device is $570,000,000.00 with a growth rate of 17.5 %. An established commercial partner can help place the product into distribution by obtaining regulatory approval, educating key opinion leaders about the product, and, more generally, in marketing what will be a groundbreaking product to sophisticated customers. Preliminary projections of gross revenue have suggested that by the end of year 1 the product will generate $10.8 million. By the end of year 3 it will have generated $60 million and by the end of year 5 will have generated over $200 million.
Advantages of Amytrapper. The advantages of the technology are that it addresses the underlying pathophysiology of Alzheimer’s disease rather than just treating its symptoms, which is what competing treatments provide. A relatively infrequent (quarterly) treatment that performs far better than competing treatments may attain a certain first-mover advantage and be perceived as a breakthrough, provided its pricing is competitive. The product will accordingly compete primarily on the basis of performance and relative convenience, providing perceived value.
Funding. Funding for the technology has so far been through peer reviewed SBIR grants from National Institutes of Health and matching support from Connecticut Innovations Inc., a semi-government entity which supports biotechnology growth in the State of Connecticut.
Intellectual Property. IP protection in the form of an issued patent from USPTO and freedom to operate (FTO) search report have been accomplished.
Company Information. Website-www.recombtech.com; ph: 203 271 3125; F: 203 271 3126; email: email@example.com