Boehringer boosts schizophrenia strategy with €25M upfront for option on Sosei’s GPR52 agonists

Boehringer Ingelheim has secured an opportunity to beef up its schizophrenia portfolio courtesy of a €25 million ($27.3 million) upfront deal with Sosei Heptares.

The agreement gives Boehringer an exclusive option to license a portfolio of GPR52 agonists led by a candidate in phase 1 development. GPR52 is a G protein-coupled receptor target that is highly expressed in the brain, and Sosei has hopes that this approach can “improve patient outcomes by simultaneously addressing positive, negative and cognitive symptoms of schizophrenia,” the biotech explained in the March 11 release.

Boehringer has bought into the idea, handing over €25 million for the option to license the portfolio once the lead candidate, dubbed HTL0048149, has completed an ongoing phase 1 trial, a subsequent phase 1b study and the phase 2 enabling activities that would come after. These hurdles are expected to be achieved at some point next year.

Boehringer will pay an additional €60 million ($65.6 million) if the license is picked up, with up to €670 million ($732.7 million) to follow in development, regulatory and commercialization milestone payments, alongside royalties on future sales should any of the candidates make it to market.

Hugh Marston, Global Head, CNS Discovery Research at Boehringer Ingelheim, said the Sosei partnership is “highly complementary” to the German drugmaker’s development programs for precision medicines aimed at mental health disorders. These include a glycine transporter type-1 (GlyT1) inhibitor called iclepertin that’s in a pair of phase 3 trials for cognitive impairment associated with schizophrenia. Boehringer is also testing digital therapeutics in late-stage trials for the condition.

HTL0048149 entered the clinic last year in a U.K. trial of healthy volunteers aged 18-55 years. An initial readout is expected in 2025.

Both HTL0048149 and the portfolio of “differentiated back-up compounds” were designed using Sosei’s StaR drug design tech. The StaR platform has already caught the eye of Eli Lilly, which paid Sosei $37 million upfront in 2022 to use the tech in diabetes and metabolic diseases.

Sosei’s hope is that by selectively targeting GPR52, the once-daily, oral drug will “address the significant proportion of schizophrenia patients who do not respond to existing treatments or are unable to tolerate some of the side effects of antipsychotics.”

Individuals with schizophrenia can experience so-called ‘positive’ symptoms, such as psychosis, delusions and hallucinations, as well as ‘negative’ symptoms like social withdrawal and apathy, and also cognitive impairment, which affects attention and memory. Current antipsychotic drugs don’t effectively treat the negative or cognitive symptoms of schizophrenia, according to Sosei.

“This collaboration highlights the significant potential GPR52 has shown in preclinical research as a novel, first-in-class target for the treatment of schizophrenia and related neurological disorders,” Matt Barnes, Sosei’s president and head of U.K. R&D, said in the release.

Boehringer has been busy on the licensing front in recent months, with highlights including a $2 billion biobucks collaboration with China’s Suzhou Ribo Life Science’s for RNA therapies for metabolic-associated steatohepatitis (MASH) and another T-cell anticancer therapy partnership with 3T Biosciences.