The startup that came out on top of the biopharma track in a recent pitch contest hopes that it could have an approval application in with the Food and Drug Administration in three years for a drug to treat acute alcoholic hepatitis, assuming clinical trial success.
Carlsbad, California-based Pleiogenix emerged as the winning biopharma company of the Pitch Perfect contest at the MedCity INVEST conference last week, which took place virtually due to the ongoing Covid-19 pandemic. The company was founded in July 2018, and its lead product candidate is PLG888, a Phase IIa-ready compound for which it is negotiating exclusive worldwide rights.
The firm plans to initially develop the drug for acute alcoholic hepatitis, or AAH, given both the dearth of available therapies for it and the relatively quick development path, CEO Joseph Evans said in a phone interview. The idea is to conduct a Phase IIa study next year, followed by an adaptive Phase IIb/III registration study in 2022 and finally file for regulatory approval in 2023, out-licensing the drug in the interim. That, of course, depends on securing funding.
“We’re very excited, and we just have to meet up with the right investors who are on the same page as us with regard to this technology,” Evans said.
According to the company’s executive summary, it is targeting $2.5 million in seed funding, with the objective of obtaining that within two years. Evans said that two-year mark is coming up, and the company hopes to have it secured within six months. The seed round would be sufficient for the filing of an investigational new drug, or IND filing, the application with the FDA that allows a company to begin clinical testing. Evans added that it is unlikely that the agency will require IND-enabling studies before that. Clinical development in AAH as well as Covid-19 – for which the company plans to develop PLG888 due to its anti-inflammatory properties – is projected to cost $30-35 million, according to the summary. In addition to the Series A funding round in which Pleiogenix would raise that money and the preceding seed funding round, it is looking to raise non-dilutive grant funding. Evans said the fundraising has attracted some interest from West Coast venture capital firms, though it is open to meeting with firms elsewhere in the U.S. as well as outside the U.S.
Beyond AAH and Covid-19, the company is looking longer-term to develop PLG888 for nonalcoholic steatohepatitis, or NASH, a fibrotic liver disease that has become a growing area of interest in the metabolic disease space over the last decade. While NASH represents a significant market opportunity – estimated at $35-40 billion worldwide by 2025 – there are no approved therapies. That’s not for lack of trying: Gilead Sciences, Genfit and Boehringer Ingelheim are among companies that have tried and failed to develop drugs for NASH. Meanwhile, the closest one to getting approval, Intercept Pharmaceuticals, was turned down by the FDA in June for its drug when the agency requested more data.
Evans sees Pleiogenix’s closest competitor not in the aforementioned companies, but in Inventiva, whose lead drug candidate, lanifibranor, has a similar mechanism of action to PLG888 and is currently in Phase IIb development for NASH. He hopes that PLG888 could prove more effective because it targets multiple receptors, whereas the drugs that have failed have been more target-specific. He cited the early experiences with tyrosine kinase inhibitors in cancers, from when he worked at Sugen, an early pioneer in the space, where TKIs were also not effective when they were too target-specific. Assuming Inventiva and Pleiogenix are successful in developing NASH drugs, he sees enough room for multiple competitors.
“We’re very positive about [Inventiva] laying the groundwork,” he said. “There’s always room for additional compounds with the same mechanism of action because they will likely have different side effect profiles and different potencies.”
Photo: MedCity News