{"id":2707,"date":"2022-11-09T09:00:07","date_gmt":"2022-11-09T09:00:07","guid":{"rendered":"https:\/\/magazines.uthscsa.edu\/schools\/?p=2707"},"modified":"2022-11-09T15:35:42","modified_gmt":"2022-11-09T15:35:42","slug":"preventing-permanent-brain-injury-after-stroke","status":"publish","type":"post","link":"https:\/\/magazines.uthscsa.edu\/schools\/2022\/11\/09\/preventing-permanent-brain-injury-after-stroke\/","title":{"rendered":"Preventing permanent brain injury after stroke"},"content":{"rendered":"

An accidental discovery<\/h2>\n

By Michael Seringer<\/em><\/h4>\n

In the early 2000s, James Lechleiter\u2019s lab at UT Health San Antonio was doing basic research focused on astrocytes, the star-shaped cells that do everything from managing neurotransmitters to clearing debris to regulating blood flow in the brain.<\/p>\n

\u201cWe thought we had a drug candidate for brain cancer that would sensitize the cells to cell death, and in fact, the exact opposite happened,\u201d Lechleiter said. \u201cWe added the drug and they were more resistant to cell death. That was surprising because we had done a lot of these same experiments with other cell types, like kidney cells, but when we got into the brain and this special astrocyte subtype, we got the surprising opposite result.\u201d<\/p>\n

\n

\"\"James Donald Lechleiter, PhD<\/strong><\/h4>\n
Professor of Cell Systems and Anatomy; Director of the Optical Imaging Core<\/em><\/h5>\n
Company:<\/strong> <\/span>Astrocyte Pharmaceuticals Inc. (private)<\/h6>\n
Compound:<\/strong><\/span> Novel, small molecule \u2014 AST-004<\/h6>\n
Indication:<\/strong><\/span> Stroke, traumatic brain injury, neurodegenerative disease<\/h6>\n
Stage:<\/strong><\/span> Completed European clinical trial application; FDA investigational new drug application expected in 2023. Currently in Phase 1 human safety trials (Europe)<\/h6>\n
Funding:<\/strong><\/span> $20 million from company formation to clinical Phase 1 human trials, including grants, angel investors<\/h6>\n
\n
Drug development requires a multidisciplinary team with experience navigating the complex and nuanced processes for advancing pharmaceutical compounds.<\/em><\/span><\/h6>\n<\/blockquote>\n
\n

Lechleiter initially assumed the research team had made mistakes during the experiment, so his lab retested several times, all with the same result. Lechleiter knew he had a potential novel finding, and he has spent the last 16 years investigating it.<\/p>\n

The mouse models used to test Lechleiter\u2019s novel compound immediately showed encouraging results. Researchers observed a 50% reduction in stroke lesion size after the mice were treated with the drug. The drug\u2019s therapeutic promise prompted UT Health San Antonio\u2019s Office of Technology Commercialization to protect the intellectual property by filing for a patent. In 2013, the patent for AST-004 was granted, which made possible the formation of Astrocyte Pharmaceuticals Inc. out of Lechleiter\u2019s lab in San Antonio.<\/p>\n

Once Astrocyte Pharmaceuticals was formed, the search began for an industry insider with experience in the business of drug development. The importance of this step can\u2019t be overstated. Successful companies require both good science and good business. Lechleiter and UT Health San Antonio were fortunate to find William Korinek, PhD, to fill the role of CEO for Astrocyte Pharmaceuticals in 2014. Korinek is a veteran from pharmaceutical giant Pfizer who recognized the potential of the compound, and over a period of four months worked on a business plan with Lechleiter.<\/p>\n

Industrializing the drug<\/strong><\/p>\n

Moving from early laboratory successes to a pharmaceutical program ready for human clinical studies requires many complex steps. For AST-004, the team needed to demonstrate the drug worked in larger animals that have brains more similar to humans such as pigs and non-human primates. Substantial quantities of the drug (kilograms) needed to be manufactured under stringent good manufacturing practice conditions.<\/p>\n

The maximum tolerated doses also needed to be identified in good laboratory practice toxicology studies. And because the first form of AST-004 is delivered intravenously, the process of developing the injectable formulation, filling the drug product vials and manufacturing the vials and the associated parts was challenging.<\/p>\n

\u201cWe are really fortunate that AST-004 is a well-behaved small molecule that was fairly easy to synthesize and manufacture, with only some tweaking of the recipe to get the optimal pH and solubility,\u201d Korinek said. \u201cOverall, while the rigorous preclinical activities take considerable time and resources, the manufacturing and\u00a0animal toxicology studies have gone smoothly. We were able to go up to a very high dose in the safety studies, which gives us confidence that we have a very safe molecule, and we now have over a thousand vials ready for the human clinical studies.\u201d<\/p>\n

Lechleiter believes the synthesis, formulation and manufacturing went well because his team hired a pharmaceutical chemist with 30 years of experience developing drug compounds.<\/p>\n

\u201cGetting someone who is really specialized and has a lot of experience in chemistry, formulation and manufacturing is crucial to be successful and make it go more smoothly,\u201d Lechleiter said, explaining that drug development requires a multidisciplinary team with experience navigating the complex and nuanced processes for advancing pharmaceutical compounds.<\/p>\n

\u201cGet someone who has done this before. Don\u2019t try to do it on your own. Seek advice from experts and be sure to document everything you have done,\u201d Lechleiter said. \u201cIt\u2019s a long process. That\u2019s why you need people who are specialists in different areas and know what to expect. All the steps take time and a lot of resources.\u201d<\/p>\n

Funding a multidisciplinary team<\/strong><\/p>\n

While large-animal efficacy research, compound manufacturing and animal safety studies went smoothly, they are also expensive, and Lechleiter and Korinek had to raise enough funds to conduct specialized research. To increase investor confidence that the drug would work in the larger and more complex human brain, the research team conducted studies in the more expensive pig and primate models. Astrocyte Pharmaceuticals relied on grants and an angel investor group to provide the necessary financing.<\/p>\n

\u201cWe first focused on applying for a small business grant and were successful in securing a $700,000 [National Institutes of Health] grant in the first year of the company,\u201d said Lechleiter. \u201cThat was a key scientific stamp of approval from independent scientists confirming this was exciting research, which was really crucial to gaining the confidence and interest of angel investor networks.\u201d<\/p>\n

Over the eight years since its founding, Astrocyte Pharmaceuticals raised and spent $15 million to get through animal trials and preclinical studies and another $5 million to conduct the human Phase 1 clinical trials.<\/p>\n

Additional patents<\/strong><\/p>\n

The company\u2019s research surrounding Lechleiter\u2019s early discoveries has resulted in multiple additional patents, including patents on using the drug to treat a variety of central nervous system indications. They also patented different molecular structures that might further improve upon the original compound and improved methods to synthesize the molecule in fewer steps, making the drug easier and cheaper to produce.<\/p>\n

AST-004 holds promise for multiple indications. During animal studies funded by a Department of Defense grant to investigate the drug\u2019s therapeutic effect on blast traumatic brain injuries, the team discovered another possible indication for the drug. During the DOD research, Jun Hee Kim, PhD, UT Health San Antonio professor in the Department of Cellular and Integrative Physiology \u2014 who has an office next door to Lechleiter\u2019s lab \u2014 suggested the lab test the hearing of the mice subjected to explosions.<\/p>\n

The mice treated with AST-004 had almost no hearing loss after the blast test, but those mice that had not been treated with AST-004 experienced significant hearing loss.<\/p>\n

\u201cIt turns out the inner ear has a lot of the same neural structure as the brain,\u201d Lechleiter said. \u201cThe receptor\u00a0subtype that we are targeting is richly expressed in the inner ear. We think the same mechanism is at play. We just weren\u2019t looking for it.\u201d<\/p>\n

\u201cWe went into this research thinking only about traumatic brain injury and stroke, but because of how the molecule is fundamentally affecting cell health and recovery in the brain, it turns out there are a lot of other indications with neuronal stress where there could be significant benefits,\u201d Lechleiter said. \u201cWe\u2019ve now seen positive data with noise-induced hearing loss, Alzheimer\u2019s disease, inflammatory pain and other areas. AST-004 appears to be activating a central neuroprotective pathway that we believe can be broadly used to help millions and millions of patients.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

In the early 2000s, James Lechleiter\u2019s lab at UT Health San Antonio was doing basic research focused on astrocytes, the star-shaped cells that do everything from managing neurotransmitters to clearing debris to regulating blood flow in the brain. 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