C4X sells full rights for substance use disorder drug to Indivior as part of refocus

Indivior has paid 15.95 million pounds sterling ($20.4 million) to C4X Discovery for the full rights to the British biotech’s orexin-1 receptor antagonist being developed for substance use disorder.

The two companies originally signed a deal back in 2018 that saw Indivior pay $10 million upfront and pledge up to $284 million in milestones if the asset, dubbed C4X3256, or a library of additional orexin-1 compounds included in the agreement proved successful.

In return for the almost 16 million pound upfront payment today, C4X is surrendering the chance to ever cash in on those milestones. The Manchester, England-based biotech framed the decision as “part of C4XD’s evolution towards becoming an immuno-inflammatory therapeutics company.”

“Indivior has made excellent progress with our orexin-1 candidate, and we are proud that they now wish to take this program fully in-house,” C4X Chief Business Officer Bhavna Hunjan said in the Aug. 1 release. “The agreement also provides an opportunity for us to crystallize value for the program early and underpins and accelerates our new strategy.”

The company will use today’s funds alongside preclinical milestone payments from an IL-17 inhibitor licensed to Sanofi and a Nrf2 activator licensed to AstraZeneca to “further advance our newly focused portfolio towards and into the clinic.”

C4X’s unpartnered portfolio centers around a MALT1 inhibitor, although the biotech said in the release that a partnering process for the asset has now been “initiated.” So far, C4X3256 is the only asset hailing from C4X that has made it into the clinic. The drug began a phase 1 multiple ascending dose trial in 2020, according to ClinicalTrials.gov.

For Indivior, getting its hands on the full rights to C4X3256, which has been rechristened INDV-2000, is “aligned with our goal to build a strong and balanced pipeline focused on addiction treatments,” Chief Scientific Officer Christian Heidbreder, Ph.D., said in today’s release.

“Importantly, we know the asset well, having worked closely with C4X Discovery for more than five years,” Heidbreder added. “We recognize its exciting potential and will continue to progress it as a novel approach to the treatment of opioid use disorder, as well as more broadly in substance use disorders.”

Indivior isn’t the only one who sees potential in the candidate. In 2019, the U.S. National Institutes of Health’s program for opioid misuse and other long-term addictions handed over a $10.6 million grant to Indivior for development of the compound.

Orexin regulates arousal, wakefulness and appetite, and focusing in on the neuropeptide has seen some regulatory success for insomnia. Idorsia, for example, secured the approval of its dual orexin receptor antagonist Quviviq as a sleeping pill. However, the Swiss biotech company had less luck trying to pursue a selective orexin-antagonist as a binge-eating disorder treatment, dropping the indication after a phase 2 trial fail.