UCB has taken a $20 million equity stake in Swiss biotherapeutics firm Synosia as part of a deal centered on development of the latter’s Phase II-stage movement disorder candidates, SYN-115 and SYN-118. The investment by UCB formed part of Synosia’s Series C financing round, which included a further $10 million investment by the firm’s existing stakeholders.
Synosia will in addition receive an up-front fee and potentially another $725 million in milestones as part the drug development and commercialization deal, which gives UCB worldwide exclusive rights to the orally bioavailable adenosine 2A antagonist SYN-115, and rights to SYN-118 for nonorphan indications. Both candidates are currently in Phase II trials for the treatment of Parkinson disease.
SYN-115 has been licensed in by Synosia from Roche for development in all indications. SYN 118 is a 4 hydroxyphenyl-pyruvate dioxygenase inhibitor that is already marketed by Swedish Orphan as Orfadin® for the treatment of hereditary tyrosinemia. Synosia licensed rights to SYN-118 from Syngenta in 2007 for development and commercialization in nonorphan diseases.
Under terms of the deal with UCB, Synosia will continue development of both candidates through to the end of Phase II development. UCB will take over for Phase III clinical development and commercialization. Additional compounds from either partner’s pipeline may also be brought into the collaboration, under mutual agreement and negotiation, with Synosia again being responsible for clinical development until the end of Phase II.
“Given the novel mechanisms and encouraging results for SYN-115 and SYN-118, as well as the financial structure of our agreement with UCB, this partnership has the potential to be a big value driver for Synosia while providing valuable new therapies for patients with movement disorders,” comments Ian Massey, Ph.D., president and CEO at the company.
In April Synosia reported positive data from a Phase IIa study with SYN-115 in Parkinson disease patients. The trial data showed the drug resulted in functional activity in relevant regions of the brain assessed using fMRI, and had positive effects on clinical measures of motor function and cognition.
At the end of September the firm reported data from an open-label clinical study with SYN-118, which showed the drug provided clinically meaningful benefits to Parkinson’s patients, demonstrated a good safety profile, and was well tolerated. The 28-day trial showed that patients treated with SYN-118 demonstrated statistically significant improvements in motor symptoms compared with baseline scores, as measured by the Unified Parkinson’s Disease Rating Scale item III (motor function). Treatment using SYN-118 also resulted in a statistically significant signal by positron emission tomography imaging in brain regions relevant to Parkinson disease, Synosia claims.
The firm’s current development pipeline includes another three candidates in Phase I or Phase II clinical development. SYN-114 and SYN-120 are 5-HT6 inhibitors targeting Alzheimer disease and cognitive disorders. SYN-117 is a dopamine beta-hydroxylase inhibitor in development for the potential treatment of drug dependency and post-traumatic stress disorder. SYN-111 is a sodium channel blocker being developed for the treatment of bipolar disorder.
Synosia and Roche inked their original multidrug development agreement back in 2007. Under terms of the deal Synosia assumed responsibility for clinical development of five drug candidates in CNS: the dopamine beta-hydroxylase inhibitor nepicastat; an A2a antagonist; a 5-HT6 antagonist; an IP inhibitor; and an mGluR1 enhancer. The firms expanded their deal in 2009 to include a second 5-HT6 antagonist. They also revised terms of the collaboration to give Synosia full development and commercialization rights to all relevant programs, with Roche retaining opt-in rights to the 5-HT6 program.