Galactica is an “IND-ready” biopharmaceutical company focused exclusively on the development of its novel, proprietary RAGE (Receptor for Advanced Glycation End Products) fusion protein. Our initial indication is the treatment of lung inflammation and cytokine storms symptomatic of COVID-19, but we are also developing the molecule for the treatment of diabetes and diabetic complications, both the dry and wet forms of macular degeneration, certain autoimmune/inflammatory disorders and possibly Alzheimer’s disease (only with NIH and/or foundation funding).
Galactica’s RAGE protein appears to be the first molecule of any type with clinical potential to have demonstrated in vivo efficacy in the treatment of three major diabetic complications- retinopathy, neuropathy and nephropathy. This is of enormous clinical significance, as many diabetics initially present with one major complication but subsequently develop multiple complications. Diabetes currently is the most expensive disease we treat in the U.S., and a vast majority of that amount is spent treating diabetic complications. If our very encouraging preclinical data are replicated in man, Galactica’s RAGE protein will save governments and other healthcare providers billions of dollars annually by effectively treating an initial diabetic complication and preventing the development of others.
Since Galactica’s drug will be administered via subcutaneous injection, for the wet form of macular degeneration, our molecule would be the drug of choice over Genentech’s Lucentis (Avastin off-label), Regeneron/Bayer’s Eylea and Novartis’ Beovu, all of which are administered via intraocular injection. Since there currently is no efficacious treatment available for the dry form of macular degeneration, Galactica’s molecule could represent the first effective therapy to address that enormous unmet clinical need.
Galactica has conducted a “Big Pharma-like” development program with our RAGE molecule, having completed five short- and long-term in vivo efficacy studies, which substantially increases the likelihood of our clinical success. We also undertook extensive upstream and downstream manufacturing process development, identifying and resolving the issues that routinely arise in biologics manufacturing, giving us a clear path to our first IND filing in 15-18 months for one of the diabetic complication indications. The COVID-19 pandemic, however, may offer us a much more rapid pathway to our first IND filing.
Galactica’s RAGE fusion protein is covered by global composition-of-matter patents and certain method of use claims. In the U.S. and Europe (and likely Japan), patent expirations will be extendable through standard pediatric and regulatory extensions.