HONG KONG – Clinical-stage biotech Guangzhou Magpie Pharmaceutical Inc. closed a series B financing round and raised nearly ¥100 million (US$14.8 million) to move its first-in-class core asset for the treatment of ischemic stroke and other drug candidates further into the clinic. Sangel Capital is backing the round on its own.
Before that round, Magpie raised more than ¥60 million from series A and A+ rounds in 2016 and 2017, the company told BioWorld, but the investors in those two rounds remain undisclosed.
Founded in 2010, Magpie focuses on unmet medical needs in cardiovascular, neurodegenerative and mitochondrial diseases. The company has built a drug discovery platform that makes it possible to chemically modify the molecular structure of the active component of clinically proven traditional Chinese medicines (TCM) and widely used synthetic drugs.
With that unique drug discovery platform, Magpie said it has developed first-in-class – and even first-in-world – drug candidates. Stressing innovation, the company self-develops assets rather than in-licensing them.
One prime example is its core asset tetramethylpyrazine nitrone (TBN), a small molecule structurally modified from traditional Chinese medicines.
"We plan to move TBN into phase II study in the treatment of acute ischemic stroke, and phase I and phase II studies in the treatment of diabetic kidney disease and amyotrophic lateral sclerosis [ALS]," Magpie's founder and CEO Yuqiang Wang told BioWorld.
TBN is also being developed to target Parkinson's disease, a formulation that is in the pre-IND stage, according to the company's website.
"If Magpie has sufficient capital, we expect to file an NDA for TBN on the treatment of acute ischemic stroke in three to four years," Wang added.
Wang himself has more than 20 years of experience in drug development in the U.S. and China. He was the director of medicinal chemistry at Panorama Research Inc., a biotech company in Silicon Valley, where he contributed to developing blockbuster Alzheimer's drug Namenda (memantine). Like other overseas returnees, Wang moved back to China to found his own biotech company.
According to Magpie, researchers synthesized TBN, which they called "a derivative of the clinically useful stroke drug tetramethylpyrazine [TMP] armed with a powerful free radical-scavenging nitrone moiety" that retains the thrombolytic activity of the parent TMP and has strong antioxidative properties.
"TBN demonstrates significant activity in the rat middle cerebral artery occlusion stroke model. The results suggest that the design of molecules possessing both thrombolytic and neuroprotective properties may be a novel strategy for effective stroke therapeutics," researchers wrote in a paper published in 2008.
Eight years later, the researchers claimed that TBN could quickly penetrate the blood-brain barrier and reach effective therapeutic concentration after the drug was injected into the vein.
That claim was supported by results from an animal trial that studied the therapeutic effects of TBN in a nonhuman primate model of stroke. Thirty male monkeys were subjected to stroke with four hours of ischemia and then reperfusion. They received an intravenous injection of TBN at three or six hours after the onset of ischemia.
"[TBN] significantly reduced brain infarction and modestly preserved the neurological function of the stroke-affected arm. [It] suppressed overexpression of neuroinflammatory marker vimentin and decreased the numbers of GFAP-positive cells," the researchers said of the results.
Clinical trials coming up
While TBN serves as a promising new clinical candidate to tackle ischemic stroke, Wang said a strategy to get the drug out on the market faster is to target orphan or rare diseases.
"At the same time, we are also developing TBN with different preparations for the treatment of some orphan or rare diseases, such as ALS, to speed up the time needed for an NDA approval," Wang explained.
Last August, China rolled out its first national list of rare diseases that includes 121 indications, including ALS. Regulators are expected to grant drugs for treating those diseases fast track designations and waive the clinical trials and data requirements.
The second most advanced asset in Magpie's pipeline is MN-08, a novel nitrate derivative of memantine. It is now in the preclinical stage for the treatment of pulmonary arterial hypertension, vascular dementia and glaucoma.
Researchers studied the pharmacokinetics of MN-08 in rats. After injecting the drug in 18 rats intravenously, researchers found that MN-08 could quickly distribute in tissues and reach the highest concentration in almost 15 minutes. They also concluded that MN-08 could penetrate the blood-brain barrier as it showed a high concentration in the brain.
Three other assets in Magpie's pipeline are T-006 for treating Parkinson's disease, AL-1 for ulcerative colitis and DT-081 for acute myocardial ischemia. They are all in very early stages.
"Between 2019 and 2020, we will see a peak of IND approvals and clinical trials for our other assets," said Wang. Magpie is expecting four to five phase I and phase II trials by the end of 2020.
When asked if Magpie intends to develop and commercialize its assets by itself, Wang said the company is open to partnerships.