US central nervous system (CNS) diseases focussed drugmaker Supernus Pharmaceuticals (Nasdaq: SUPN) and privately-held Navitor Pharmaceuticals late Tuesday announced a joint development and option agreement for Navitor’s mTORC1 activator, NV-5138.
NV-5138 is a first-in-class, orally-active small molecule that directly activates brain mTORC1, the gatekeeper of cellular metabolism and renewal, which is often suppressed in people suffering from depression.
Phase I data demonstrated early proof of concept in which a single dose of NV-5138 showed rapid and sustained improvement in core symptoms of depression with favorable safety and tolerability in patients with treatment-resistant depression (TRD).
Terms of the collaboration
Under the terms of the agreement, Supernus and Navitor will jointly conduct a Phase II clinical program for NV-5138 in TRD. Supernus will pay the costs of the Phase II development up to $50 million. Total payments, exclusive of royalty payments on net sales of NV-5138 and development costs under the agreement, have the potential to reach $410 million to $475 million.
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