Shares in Intec Pharma have been poleaxed after a phase 3 trial of a Parkinson’s disease drug based on its Accordion delivery technology missed the mark.
The Accordion formulation of the standard Parkinson’s treatment combination of levodopa and carbidopa, called AP-CD/LD and designed to improve gastric retention and so deliver a longer-acting dose to the patient, performed no better than the standard formulation in the trial on Parkinson’s symptoms.
In fact, AP-CD/LD failed across the board on both primary and secondary endpoints, sparking an 80% crash in Intec’s shares as investors reacted to the loss of its lead drug candidate, and the notion that the Accordion delivery platform may not pass muster.
Analysts at Ladenburg Thalmann said they were “surprised and disappointed” by the results, and had downgraded Intec’s shares from Buy to Neutral as a result.
The trial enrolled 462 adults with advanced Parkinson’s who were initially treated Merck & Co/MSD’s immediate-release Sinemet (carbidopa/levodopa) product, and then switched to the drugs delivered via the Accordion system.
Intec chief medical officer Michael Gendreau pointed to some subsets of patients that seemed to do remarkably well on the experimental drug, with a meaningful reduction in ‘off’ time – when muscle stiffness, slow movements, and difficulty starting movements known as ‘freezing’ manifest despite treatment. A reduction in off time was the primary endpoint in the trial.
Off episodes are a major problem for patients who have been on long term therapy with levodopa-based therapy, occurring in up to 50% of all patients on treatment for five years or more. Intec has pledged to delve into its data to see if there is a path forward for AP-CD/LD, but that currently looks like a faint hope.
Intec’s lifeline now is a partnership with Novartis to advance an Accordion formulation of one of its drugs into a phase 2 proof-of-concept study. A decision on that is due to be made in the autumn, according to Ladenburg Thalmann, as phase 1 data is being reviewed over the summer.
The analysts say Intec’s chief executive – Jeffrey Meckler – has indicated that the Novartis deal could bring in “$30m to $80m upfront, plus single-digit royalties plus milestones”, which would help fund operations into 2020. Intec had around $32m in cash at the end of May, down from $39m at the end of 2018.
They believe the design of the AP-CD/LD trial inflated the benefit of the Sinemet arm, as it allowed for higher doses of the comparator drug that boosted its effects on off time, reducing it by 1.5 hours versus around 1 hour in earlier studies.
Also in the pipeline for Intec is an Accordion formulations of cannabidiol and tetrahydrocannabidiol that have compared favourably to GW Pharma’s Sativex product in early-stage testing, achieving higher levels of the active ingredient in the blood.
The emergence of the cannabis product sector in light of relaxed rules in countries like the UK, Germany and Canada is also significant, with analysts saying there could be “considerable upside” for Intec from that project.