Lpath, Ince. (OTC BB: LPTN), with milestone Phase II trials underway and the high-profile backing of Pfizer, Inc. (NYSEE: PFE), is starting to make some noise in the biotech sector with its novel disease-treating technology that includes the targeting of bioactive lipids to inhibit the spreading and growth of various modern day diseases.
Through its proprietary drug-discovery platform, ImmuneY2, Lpath has developed a pipeline of two lead product candidates, iSONEP and ASONEP, with a third, Lpathomab, in earlier stages of development, and all being helped along financially by larger players in the pharmaceutical and government-sponsored research markets.
Lpath’s ImmuneY2 platform contains the ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to the spreading and growth of various diseases and inflammatory/auto-immune disorders. The market potential for this technology in treating a plethora of modern day illnesses and diseases, should it advance past the clinical stages, is huge, and Lpath is first applying its technology to the treatment of Wet AMD and cancer, both multi-billion dollar markets; but that could just be the the beginning.
It could the sheer market potential of Lpath’s pipeline technology that attracted Pfizer, or the fact that Lpath has become the recognized leader in the field of lipid-based therapeutics as the only company to take successfully take it this far, but whatever the reason, Pfizer’s relationship with Lpath adds a significant amount of validation to the ImmuneY2 pipeline. It also offers Lpath a layer of strategic and financial security that is generally only afforded to later-staged companies.
Pfizer jumped on board about a year ago when it became apparent that Lpath was, at least to date, the only company to have successfully developed monoclonal antibodies against bioactive lipids, although the targeting of bioactive signaling lipids has been the subject of increased medical research over recent years.
Through the licensing agreement, Lpath has granted Pfizer a limited first right of refusal for ASONEP in the treatment of cancer, but it was the Phase II-ready iSONEP that Pfizer first eyeballed. The agreement came with a significant up-front payment and could be worth as much as nearly half a billion dollars, should certain milestones be met and should Pfizer decide to continue the relationship following the completion of the Phase II phase. If Pfizer stays on for iSONEP commercialization, Lpath would be due double digit royalties on sales. Given the aging and longer-living US population, the market potential for the Wet AMD indication is growing exponentially.
Over the past couple of months, Lpath has announced the dosing of two proof-of-concept trials for iSONEP.
The first , PEDigree, will measure iSONEP as a treatment for retinal pigment epithelium detachment (“RPE detachment” or “PED”), while the second , Nexus, targets Wet AMD.
Phase I trials proved that iSONEP treatment was well tolerated in all subjects, while demonstrations of efficacy were also noted, creating an encouraging landscape moving into the next round of studies.
The results of both trials are expected to be announced in 2012.
It’s a significant show of faith for a small player like Lpath to land a world wide pharmaceutical leader such as Pfizer at such early stages of development.
Mikael Dolsten, president of Pfizer Worldwide Research and Development, noted in regards to the agreement that, “We have been impressed by Lpath’s innovative approach in targeting bioactive lipids with iSONEP and the potential opportunity to significantly add to current standards of treatment in retinal disease.”
In addition to the ongoing iSONEP Phase II trials, Lpath is readying ASONEP for Phase II. Initiation of these trials is set for next year and follows encouraging Phase I testing that showed the treatment as well-tolerated, while also demonstrating efficacy. ASONEP utilizes Lpath’s lipid-based therapeutics in targeting cancer.
As per the terms of the partnership, Pfizer retains the right of first refusal for ASONEP licensing until December, 2013.
Lpathomab is still in the preclinical stages of development with an IND scheduled for 2012 or 2013, according to the company website , but is being streamlined to potentially target the lucrative pain and fibrosis markets.
Even though Lpathomab is still preclinical, the company managed to secure significant funding from the National Institutes of Health’s (NIH) Type 1 Diabetes Preclinical Testing Program for the further study of Lpathomab’s efficacy in animal models of disease, particularly diabetic neuropathy, according to a report issued this past summer.
While still years away from bringing its pipeline to market, the unique technology offered by Lpath,and its success-to-date in administering it makes this company one to monitor as milestone events get underway and become potential short to mid term catalysts.
With the novel platform developed by Lpath, it’s also safe to consider this company and/or its pipeline as a potential acquisition target.
Disclosure: No position.