WA biotechs Emyria, Little Green Pharma unfazed by FDA advisory panel’s vote against MDMA therapy

WA biotech executives have not been deterred by recent news that advisers to the US health regulator have voted against the use of MDMA as a treatment for post-traumatic stress disorder. A panel of experts convened by the US Food and Drug Administration this week voted 10-1 against the overall benefits of MDMA when used to treat the mental health disorder. The FDA is not required to follow the committee’s votes, with a final decision expected in August. But Michael Winlo, managing director of ASX-listed Emyria, said the ruling did not discount the potential of these treatments. “From our point of view, we are already incredibly encouraged by the results we’re getting and these are patients well-known to us who have truly not responded to anything else,” he said. “We didn’t expect the road to be easy. In fact it needs to be heavily scrutinised and monitored, and therefore really responsibly evaluated. “I actually see this as a unique opportunity as a further motivation to do things exceptionally well at our service.” Emryia in January announced its psychiatry specialist had been granted an authorised prescriber status by the Therapeutic Goods Administration, allowing them to prescribe MDMA-assisted therapy to patients who suffer from the mental health condition and may not qualify for a clinical trial. Australia last year became the first country in the world to legalise the use of psychedelics to treat some mental health conditions. The TGA approved medicines containing psilocybin — a psychedelic compound found in magic mushrooms — and MDMA to be prescribed to patients by authorised prescribers from July last year. Fleta Solomon, founder and executive director of fellow ASX-listed biotech Little Green Pharma — which grows and provides medicinal cannabis oils and flowers — is not “too concerned” about the ruling from the FDA advisory committee. Little Green Pharma, through its psychedelics-focused subsidiary Reset Mind Sciences, is sponsoring a clinical trial using psilocybin on patients with treatment-resistant depression. “That’s just an interim decision . . . the FDA can easily override that and in actual fact, that’s what happened here in Australia to get psilocybin down scheduled,” Ms Solomon said. “Speaking for the psilocybin point of view, I think its really quiet positive for not only Little Green Pharma but also Australia because . . . the whole world will turn to us, I think they probably already have but more so now.” While the two biotech bosses saw the silver lining, investors were less enthusiastic. Little Green Pharma shares closed down 4 per cent to 12¢, while Emyria shares closed down 3.3 per cent to 5.8¢ on Wednesday.