Amneal touts results from Phase III trial in Parkinson's; NovaRock partners on cancer drug
Amneal Pharmaceuticals announced positive results yesterday from a pivotal Phase III clinical trial that evaluated IPX-203 in patients with Parkinson’s disease who have motor fluctuations.
The trial met its primary endpoint, demonstrating superior “Good On” time — time without dyskinesia — from baseline in hours per day at the end of the 13-week double-blinded treatment period with IPX-203, an extended-release formulation of carbidopa/levodopa. The drug data was compared with immediate-release carbidopa/levodopa.
Based on these results, Amneal plans to submit an NDA for IPX-203 with the FDA in mid-2022.
“These positive data from the Phase 3 trial of IPX-203 represent a substantial step forward in strengthening Amneal’s Specialty Pharma portfolio, which is heavily focused on medicines for central nervous system disorders. We look forward to submitting an NDA with the FDA and potentially making this treatment available to the PD community,” co-CEOs Chirag and Chintu Patel said in a statement. — Paul Schloesser
NovaRock bags $7.5M in cash for cancer drug pact
NovaRock Biotherapeutics today announced that they have entered into an exclusive license agreement and strategic partnership with Flame Biosciences.
“We are very pleased to be partnering with Flame and their world-class clinical team. The collaboration with Flame marks a solid step towards getting NovaRock’s innovative portfolio into the global market,” said Han Li, CEO of NovaRock.
Under their agreement, NovaRock has granted Flame the exclusive rights to NBL-015, NovaRock’s clinical stage program for pancreatic and gastric cancer. While those exclusive rights are limited to everywhere outside of China, Hong Kong, Macau, and Taiwan, Flame is responsible for the development, regulatory approval, and commercialization of NBL-015.
NBL-015’s IND was cleared by the FDA in May.
Flame will also collaborate with NovaRock on discovering and developing two new bispecific antibodies, for which Flame will retain exclusive rights. Those antibodies are expected to hit clinical development in approximately two years.
NovaRock will receive an upfront payment of $7.5 million with the potential to receive development milestone payments of up to $172.5 million. NovaRock is also eligible to receive sales milestone payments of up to $460 million and royalties based on a certain percentage of the net sales of those new antibodies. — Paul Schloesser
MS expert at Johns Hopkins to collaborate on NLRX1 research
Multiple sclerosis expert Peter Calabresi, a professor of neurology at Johns Hopkins, has signed on to collaborate with Landos Biopharma to validate the NLRX1 immunometabolic pathway in MS.
Their lead drug, NX-13, is an NLRX1 agonist in development for ulcerative colitis and Crohn’s disease. And now the biotech plans to use NIH funds to explore how it may work in CNS, with both MS and Alzheimer’s on the radar.
The company was founded by Virginia Tech professor Josep Bassaganya-Riera and won early backing from Chris Garabedian at Xontogeny. — John Carroll