With one rival down, Novartis-partnered biotech scores $100M round to fund mid-stage trials of fibrosis drug
When Pliant Therapeutics bagged its $62 million B round almost two years ago, CEO Bernard Coulie positioned its lead program in idiopathic pulmonary fibrosis right behind Biogen, which he sees as a frontrunner 18 months ahead.
Coming into the Series C, that’s no longer the case. Biogen scrapped its Phase II trial last September due to safety concerns, leaving Pliant even more room to make a splash with the mid-stage programs it now plans to run with $100 million of new cash in the bank.
While Pliant’s scientific co-founder, Dean Sheppard of UCSF, helped inspire the rival program at Stromedix that was eventually sold to Biogen, his latest idea revolves around a small molecule integrin inhibitor rather than an antibody. Pliant’s drug, PLN-74809, also hits one more target than BG00011: In addition to αvβ6, it also blocks αvβ1 integrins.
“For us, the lesson learned is stay away from an immune-stimulatory antibody in a disease population that is quite sensitive to immune stimulation,” Coulie told Endpoints News.
The new funding — coming from new backers Redmile Group, Farallon Capital Management, Cormorant Asset Management, Surveyor Capital and Logos Capital as well as existing investors including Eventide Asset Management, Cowen Healthcare Investments, Schroder Adveq, Menlo Ventures, S-Cubed Capital, Agent Capital and others — will foot the bill for two Phase IIa studies in IPF as well as a Phase II in primary sclerosing cholangitis.
Recently completed Phase I trials have given them biological proof-of-concept and confidence that a low dose, at 40 mg, is sufficient, Coulie said.
The theory is that blocking these integrins can prevent downstream activation of TGF-β, which Pliant believes is the main culprit of fibrosis — whether in the lung or liver or bile duct.
It’s the same theory behind its second asset, designed to stop the TGF-β activation itself. Late last year Novartis handed off $80 million to partner on PLN-1474 with an eye on treating end-stage fibrosis in NASH, a highly lucrative field with quite a few different corners to plough. Pliant is in the process of conducting a Phase I before — assuming it’s successful — transferring the asset to its pharma giant partner.
With its lead drug, Coulie said they plan to continue going it alone to prove its value with IPF and PSC, both challenging indications that have eluded drugmakers from Global Blood Therapeutics to CymaBay.
PSC remains an open field, he added, and there’s resurgent interest in IPF.
“We’ve seen some recent deals basically establishing the scarcity value in this specific indication,” he said, citing Roche’s $1.4 billion acquisition of Promedior based on “kind of OK” Phase IIb efficacy, Gilead’s $5.1 billion expanded tie-up with Galapagos largely driven by an IPF autotaxin inhibitor, and a number of early deals by Boehringer Ingelheim.
“So I think the competitors are quite clear,” Coulie said. “I think FibroGen is one of them, Galapagos is the other one, but I think with the mechanisms that they are pursuing versus what we use, we think we have a better chance in terms of efficacy versus those drugs.”
We should find out in 2021 as data from the three-month mid-stage studies trickle in, though the PSC trial might take a bit longer as it’s starting later in the second quarter.