Atai announced the launch of Revixia Life Sciences (Revixia), a wholly owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders.
Derived from Salvia divinorum, SalA is a unique non-nitrogenous agonist of the kappa-opioid receptor (KOR) with potential use in treatment-resistant depression (TRD), substance use disorder (SUD) and pain. Traditionally, Salvia divinorum has been used by the Mazatec people in Oaxaca, Mexico for a variety of illnesses, such as diarrhoea, headaches and rheumatism, as well as for palliative care.
SalA is an atypical KOR agonist with a complex pharmacological profile. Its mechanism of action (MoA) shows no interaction at the 5-HT2A serotonin receptor, which is the main molecular target for the classical hallucinogens such as psilocybin and DMT. Instead, it is hypothesised that SalA indirectly influences the cannabinoid system, as well as being an allosteric modulator of the µ opioid receptor.
Clinically, there are published reports of the potential benefits of Salvia divinorum in the treatment of TRD. Karl Hanes reported on 7 patients with TRD who described relief from depressive symptoms with continued oral consumption of salvia leaves three times a week. Most of these patients reported lasting benefits from their use of the herb with significantly reduced scores on quantitative measures of depression and several reported benefits such as mood enhancement, increased feelings of relaxation and increased self-awareness. Additionally, a recent study in rhesus monkeys demonstrated that SalA can decrease oxycodone self-administration in rhesus monkeys in a dose-dependent manner, suggesting that combinations of oxycodone and the KOR agonists should be further investigated as potential analgesics with reduced abuse liability.
"Due to SalA’s short psychedelic effect, it will be an attractive option for those who would like psychedelic treatment but are unwilling or unable to participate in longer sessions," said Glenn Short, CEO of Revixia. "The shorter experience will allow for more practical administration and monitoring, which may even make it possible to attend psychotherapy sessions on the same day."
"While SalA has until now been understudied, its unique MoA may allow for combination with SSRIs, potentially giving patients a better chance in beating depression," said Srinivas Rao, CSO and co-founder of atai Life Sciences. “We’re thrilled to be pursuing SalA and progressing research, as we strive for new treatments.”
Importantly, Revixia’s product will be paired with a digital therapeutic being developed by atai company Introspect Digital Therapeutics, with the aim of streamlining preparation, integration, and continued patient engagement.
“In exploring SalA, Revixia aims to develop a product with a differentiated pharmacological and treatment effect. Considering the significance of prior evidence in humans in parallel with the substantial unmet need in TRD, we believe Revixia has high commercial potential and an increased probability of success in the clinic,” said Florian Brand, CEO and co-founder of atai Life Sciences. “SalA is a great product candidate that magnificently matches the criteria we strive for, with recognized synergies across the atai platform.”
Development is underway with clinical trials expected to begin in the second half of 2022.
Aardvark Therapeutics, Inc., a clinical stage biopharmaceutical company focused on developing and commercializing novel small molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications today announced the successful completion of a $29 million Series B financing. The financing was led by Sorrento Therapeutics with participation from existing investors including Vickers Venture Partners, Premier Partners, BNH Investment, and Korea Omega. The Foundation for Prader-Willi Research also participated as an investor in the Series B.
According to Aardvark, the funds raised will be deployed to (1) complete three Phase 2 clinical trials of the company's lead compound, ARD-101, a potent first-in-class small molecule TAS2R (bitter taste receptor) pan-agonist; and (2) to advance several potential additional formulations for major indications. ARD-101 demonstrated safety in Phase 1 human trials. Further, ARD-101 has been shown to convey beneficial effects in animal models of obesity as well as hyperphagia, diabetes, hyperlipidemia, and inflammation.
Commenting on the developments, Aardvark Therapeutics CEO, Tien Lee, M.D., said "We believe our lead compound, ARD-101, is differentiated from existing standard-of-care drugs in both its anticipated safety profile as well as its potential broad spectrum of effects. It is a first-in-class compound that impacts metabolic and inflammatory mediators. We are delighted that our existing investors are confident with our progress as well as the interest of new investors, in maximizing the potential of this unique therapeutic composition."
John Walter, CEO of the Foundation for Prader Willi Research (FPWR), added, "The Foundation for Prader Willi Research is excited to partner with Aardvark to launch their Phase 2 trial in Prader Willi Syndrome (PWS) later this year. Given the spectrum nature of PWS there is recognition that we will need multiple therapies to address the hallmark symptoms of the disorder. Aardvark's ARD-101 targets multiple pathways potentially relevant to PWS and has the potential of improving the lives of those suffering from PWS and those who care for them."
Atai Life Sciences (ATAI), began trading on the Nasdaq on June 18, 2021. ATAI Life Sciences is a private biopharmaceutical company that was founded in 2018. It is based in Berlin, Germany. The company seeks to develop effective mental health treatments by researching both psychedelic and non-psychedelic compounds. It is structured as a biotech holding company which offers excellent diversification and is backed by serious institutional investors including Christian Angermayer, Mike Novogratz, Peter Thiel, Woodline Partners, Pura Vida Pro, and Subversive Capital. Compass Pathways is one of ATAI's largest holdings and is expected to report TRD psilocybin results this year. Previous to IPO the company had raised a total of $347.1M in funding over 8 rounds.
