In just under three weeks, Sage Therapeutics should hear back from the FDA on its filing for new antidepressant Zulresso, and the company has just raised $575m to help the commercial rollout if approved.
Sage already has a positive FDA advisory committee meeting in hand for GABAA modulator Zulresso (brexanolone) as a fast-acting, intravenous therapy for post-partum depression (PPD), and should get a verdict from the regulator by 19 March.
If approved, it could become the first product specifically indicated for PPD, which affects an estimated 400,000 women in the US each year and in severe cases it can raise the risk of suicide or even harm to the baby.
Unlike conventional antidepressants, which can take weeks to kick in, Zulresso starts working within two to three days of dosing and can lift women quickly out of the sadness, anxiety, irritability, and social withdrawal that can accompany PPD. It has a breakthrough designation from the FDA for PPD.
Topping the list of plans for the oversubscribed public placement is to build up Sage’s development and commercial capabilities ahead of a possible US launch for Zulresso, says the company’s SEC prospectus for the fundraising.
It will also use the cash to accelerate the development of pipeline programmes including SAGE-217, a follow-up antidepressant with the same mechanism of action that Sage thinks has even more commercial potential than Zulresso.
SAGE-217 met its targets in a phase 3 trial in PPD reported at the JP Morgan conference last month, and according to the company the candidate seems to offer rapid efficacy in tackling symptoms – just like Zulresso – but is less prone to causing side effects including loss of consciousness. It also has an FDA breakthrough designation for this indication.
The follow-up is also being developed in a phase 3 programme as a short oral course for major depressive disorder, with results due in 2020. It is also in earlier-stage studies for MDD plus insomnia as a maintenance therapy for depression and bipolar disorder.
The cash injection will also help Sage bring forward its lead neurology candidate SAG-324 for essential tremor and epileptiform disorders, and neuropsychiatry candidate SAGE-718 for cognition-related disorders such as Huntington’s disease, both of which are in phase 1 testing.
Shares in Sage rose 4% in the wake of the fundraising. The company has been repeatedly mentioned in dispatches as a possible takeover target by a big pharma group as its pipeline matures.