- Raised $4.3M to date of $6M Series A-1 Preferred Stock Offering.
• Research partnership funding: None; Seeking major pharma partners
• Partnership with Pacific Rim Strategic Partner (SynCore Bio-2011)
MacuCLEAR’s lead compound is MC-1101, an eye-drop treatment for early stage (dry) age-related macular degeneration (AMD). More particularly, the compound is meant to halt the progression of AMD from dry AMD to the late-stage (wet) form of AMD by increasing ocular blood flow in the choroidal vessels. MacuCLEAR is jumping into Phase 3 after Phase Ib/proof of concept trial “showed that this drug is not only safe and well tolerated by study subjects, but MC-1101 eye drops also migrate to the back
of the eye through proven pathways and provide unique and effective treatment
for AMD at the source of the problem by increasing blood flow in the back of the
• Phase 3 trial of lead product MC-1101 for dry AMD launched in April 2012.
- Novel endpoint based on visual function will be used to prove efficacy of MC-1101 in a 60 patient, double blinded, placebo controlled study. If the study is successful, this trial may be considered part of a total of 500 patients registration requirement for NDA submission.
• US Patent issued in US; additional CIP filed, IP in process for filing in Pacific Rim and India; Trademarks issued for key marks.
• Independent research presented at NYU Pisart Lecture series in January, shows Reticular Macular Disease is a result of choroidal ischemia that “could benefit from a vasoactive drug like MacuCLEAR’s”
WHAT’S AT STAKE
What are the most obvious differences between MacuCLEAR and the previous company, Epizyme? The previous one is in preclinical research with products from a platform, but already has a wealth of partnerships and funding. This one has just entered Phase 3 with the lead product in its pipeline, yet still seeks greater funding and a large partner to pay for its R&D. Anyone familiar with the life science partnering scene knows that the comparison typifies a common irony with investors and partners: they are human beings more comfortable with risk projected into the far future than into a relatively immediate one. With VCs, that statement may seem contradicted by their eagerness to reap a large ROI, but in fact they prefer early stage investment because it is easier to pass on to the next set of investors: partners and possibly stockholders. Products in Phase 2 to 3 are simply harder to sell to that set, because you are asking them to risk their reputations and careers on proof of concept, on the results of testing the product in human beings. Thus, it is human risk-taking versus the human body, and the body always wins.
About the only way a small company in Phase 3 can counter investors’ early stage bias is by developing a potential blockbuster. When the market is huge, human greed often trumps human vulnerability and its attendant risk of clinical failure. That is what MacuCLEAR apparently intends to do. If it can somehow fund its Phase 3 trial for MC-1101, it will lead the field in dry AMD. Not bad for a little company that could in a small Texas town. MacuCLEAR’s CEO speaks non-stop with excitement over the prospect. After all, his chief scientist, George Chiou, Ph.D., helped invent the pioneering glaucoma drug, Timolol. And the lead-product concept — preventing wet AMD by treating dry AMD — seems to have broad if not universal support. But to the company’s David, there are several Goliaths: large companies that, if they are not to be partners, will surely be competitors. With 11 other ophthalmology products in the pipeline, MacuCLEAR looks like a clear prospect for acquisition, perhaps more so than strategic partnering, and it will be fascinating to see whether the company has to push on through its Phase 3 trial alone before either one happens.