Boehringer Ingelheim’s trio of late-stage schizophrenia failures on Thursday came a day after the Department of Health and Human Services hit back on the pharma’s legal challenge to the IRA’s drug price negotiation program.
The past few days have been rough for Boehringer Ingelheim, a trend that continued this week. On Thursday the German pharma suffered a late-stage setback for its schizophrenia program, and on Wednesday was on the receiving end of a strongly worded court rebuttal from the Department of Health and Human Services.
According to Boehringer’s Thursday announcement, the Phase III CONNEX program of its investigational drug iclepertin, being tested for schizophrenia, did not meet its primary and key secondary endpoints. At six months, Boehringer reported that iclepertin failed to elicit significant cognitive or functional improvements versus placebo in any of the three CONNEX studies.
With these results, Boehringer has decided to not go forward with CONNEX’s long-term extension trial, “effective immediately,” according to its press release. The company added that it will present results from the study at an upcoming scientific congress to “aid scientific understanding and inform future research” in schizophrenia.
Shashank Deshpande, head of Human Pharma at Boehringer, called these findings “disappointing” in the statement, nevertheless saying that “in the near future more can be expected” from the pharma and its efforts in mood disorders. “Our innovative pipeline includes over 20 additional investigative therapies in all stages of development and in different disease areas including schizophrenia and major depressive disorder,” Deshpande added.
Iclepertin is an investigational and orally available inhibitor of glycine transporter 1, which regulates both excitatory and inhibitory neurotransmission. It is not clear what Boehringer’s plans for iclepertin are. The asset remains listed on its pipeline webpage as of Friday morning.
A day before the iclepertin announcement, the HHS in a court filing hit back at Boehringer’s legal challenge to the Inflation Reduction Act’s drug price negotiation program.
Like many of its big pharma peers—including Johnson & Johnson and Bristol Myers Squibb—Boehringer has tried and so far failed to induce courts to block the IRA’s price negotiation provisions. The pharma sued the government in August 2023, claiming that the price negotiations constitute a forceful taking of companies’ properties, violating the Fifth Amendment right to due process and just compensation.
In July 2024, however, a Connecticut court ruled against Boehringer, stating that the company’s participation in the negotiations is voluntary. It can choose to opt out of the IRA program “even if [the company] has a considerable economic incentive to participate.” The judge also took the government’s side, noting that it “is free to use its economic power as a bulk purchaser of certain goods to negotiate better deals for those goods.”
The HHS reiterated the same arguments in its court filing on Wednesday, insisting that the program remained voluntary, a fact that “undermines most of [Boehringer’s] constitutional claims.”
“In setting the terms of its offer to pay for drugs for Medicare beneficiaries, the government has neither mandated the transfer of Boehringer’s property nor deprived Boehringer of any protected property interest,” the HHS continued. “If participating in Medicare stopped being profitable, Boehringer could walk away.”
