FDA adcomm votes in favor of new antifungal; Denali gets $25M from Sanofi MS trial milestone
The FDA’s Antimicrobial Drugs Advisory Committee voted 14-1 in favor of a limited-use indication for Cidara Therapeutics’ rezafungin, a treatment for candidemia and invasive candidiasis.
According to Cidara on Wednesday, the vote was based on data from two trials run by Cidara, with a once-weekly dose of rezafungin demonstrating statistical non-inferiority versus caspofungin, the current standard.
“This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin if approved, could provide an effective new alternative for patients battling these potentially deadly diseases,” said Jeffrey Stein, Cidara’s CEO in a statement.
Cidara’s NDA was accepted and given a priority review last September and was assigned a PDUFA date for March 22, 2023. Also in 2022, Melinta Therapeutics announced that it acquired the rights to commercialize rezafungin in the US, with Cidara hanging on to rights in Japan. Cidara licensed the rights to Mundipharma in other regions. The EMA accepted the marketing authorization for the drug last August and it is currently under review. — Tyler Patchen
Sanofi starts dosing multiple sclerosis in PhII trial
Sanofi has started dosing in a Phase II trial of an RIPK1 inhibitor for multiple sclerosis, triggering a $25 million payment to Denali.
The two started collaborating on Denali’s program in 2018 when Sanofi paid $125 million upfront to partner on its RIPK1 programs. The duo is going after neurodegenerative and inflammatory diseases. However, they tossed the initial lead candidate for neurodegenerative diseases after disappointing early-stage results in Alzheimer’s disease and ALS, prioritizing the current inhibitor SAR44382 instead.
As RIPK1 is a kinase that plays important roles in regulating inflammation and cell death, the hope is that inhibiting it will tamp down inflammation in the brain and slow neurodegeneration.
“Following the initiation of the Phase II HIMALAYA study in ALS with SAR443820 last year by Sanofi, this Phase II study in multiple sclerosis marks another important milestone for our RIPK1 program,” Denali CMO Carole Ho said in a statement.
Sanofi and Denali are also testing a separate RIPK1 inhibitor in cutaneous lupus and ulcerative colitis. — Lei Lei Wu
Small Pharma uncovers PhIIa results for major depressive disorder candidate
UK-based psychedelics biotech Small Pharma has lifted the veil on Phase IIa results for a candidate to treat major depressive disorder (MDD).
Small Pharma’s drug, dubbed SPL026, is an intravenous treatment that uses N, N-Dimethyltryptamine, or DMT, with supportive therapy to treat MDD. It hit the primary endpoint, showing a “statically significant and clinically relevant” reduction of depressive symptoms two weeks after the dose when put up against a placebo. Patients were dosed with 21.5 mg of the drug, giving a 20- to 30-minute “psychedelic experience,” the company said.
For the study’s primary endpoint, patients had a 7.4-point reduction on the Montgomery-Asberg depression rating scale (MADRS), compared to placebo, netting a p-value of p=0.02. The secondary endpoint of a “rapid onset of antidepressant effect” one week after dosing had a 10.8 reduction in the MADRS score against placebo and a p-value of p=0.002. Small Pharma also noted no apparent difference in the antidepressant effect being observed between a one and two-dose regimen of the drug.
While no drug-related serious adverse events or suicidal behaviors were reported, 19 adverse events were reported in the treatment group and four in the placebo group. Small Pharma stated that adverse effects were possibly related to being treated in the blinded phase. All adverse effects were mild or moderate in severity and most of the events were resolved during the dosing visit.
Carol Routledge, Small Pharma’s chief medical and scientific officer said in a statement that the Phase IIb study will seek to explore the safety and efficacy of the drug in a wider MDD population.
“SPL026 with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57% at three months following a single dose of SPL026. It was encouraging to see that SPL026 demonstrated a favorable safety and tolerability profile in MDD patients in this study, consistent with our Phase I study,” Routledge said in her statement. — Tyler Patchen