Health Check: Investors are wide awake for Avecho’s pending insomnia trial results | Stockhead
Another rough night? Have another coffee and hang in there, because relief could be at hand. Pic: Getty ImagesNo need to set the alarm: Avecho’s phase III sleeplessness results are imminentCynata mulls its. . .
Another rough night? Have another coffee and hang in there, because relief could be at hand. Pic: Getty ImagesNo need to set the alarm: Avecho’s phase III sleeplessness results are imminentCynata mulls its Plan B after dual stem cell trial failRecce upgrades its local diabetic foot injury trial after positive safety reviewAvecho (ASX:AVE)shares this morning entered trading halt ahead of interim results from the company’s phase III insomnia trial – the next in a swelling queue of pending local late-stage study reveals. The study has tested Avecho’s synthetic cannabidiol (CBD) therapy, in view of local approval as an over the counter (OTC) pharmacy medication. CEO Dr Paul Gavin believes the study is the world’s biggest phase III trial for CBD and insomnia. The trial enrolled around 520 patients. These subjects received nightly doses of either 75 milligrams or 150mg, or a placebo for eight weeks. The enrollees used questionnaires and daily sleep diaries to record the duration and quality of their slumber. Avecho’s agent does not contain the psychoactive element, THC. Avecho reckons about 10-30% of people globally have symptoms of insomnia, with 10-15% classified as chronic sufferers. So don’t always blame the soccer for that morning blurriness. Pursuing the OTC prizeCannabinoid-based drug developers have been able to access the OTC route for some time. But they face onerous manufacturing and quality hurdles. The Therapeutic Goods Administration has not approved any OTC therapies to date. In March 2025 Avecho signed a ten-year development and licensing agreement with Sandoz Group. The world’s biggest generic drug maker, Sandoz obtained the exclusive Australian rights to the treatment. Avecho pocketed US$3 million ($4. 8 million) upfront. It’s also in line for US$16 million in development milestones and sales royalties of 14-19%. The company can commercialise the product in other geographies. Avecho shares closed at 1. 5 cents on Friday, having crept up 25% over the week. Cynata gets off the matTheCynata Therapeutics (ASX:CYP)board today met to thrash out the company’s future, after its two key stem cell trials failed to meet their secondary endpoints. “The board is actively reviewing our current situation and working out what is next,” CEO Dr Kilian Kelly told an investor hook-up this morning. “We are confident in our ability to keep the lights on while we … evaluate the different options and then make the right decision. “We’re trying to find the best outcome from a bad situation for all of our shareholders. ”In short, Cynata’s phase II graft-versus-host disease (GvHD) and phase III knee osteoarthritis studies fell victim to a better-than-expected performance from the control (placebo) groups. Cynata’s drug candidates worked. But in both cases, the company had expected a stronger response from the active cohort. “We are very disappointed and quite shocked by the results,” chairman Dr Geoff Brooke said. “Everyone had put their heart and soul in this for a number of years, as well as shareholders’ hard-earned cash. ”Kelly said the poor GvHD read-out was “especially unexpected, given the strong phase I results”. The company could not replicate the structure of the phase I study, which recruited patients who had not responded to steroids. The trial design was complicated by the emergence of a new drug, the janus kinase inhibitor ruxolitinib, for these patients. In the case of knee osteo, Kelly said pain evaluation is subjective and always hard to measure. The University of Sydney initiated and funded the knee osteo study. The institution separately is analysing the results on more “holistic” measures. What’s next?Cynata is based on a platform technology, Cymerus, which seeks to overcome the limitations of conventional mesenchymal stem cell production. The idea is to make induced pluripotent stem cells at commercial scale, without needing to obtain tissue from multiple donors. Cynata has two secondary programs, for kidney transplant rejection and diabetic foot ulcers (DFUs). The Leiden University Hospital in The Netherlands conducts the former. A recent safety review gave a clean bill of health for the first three patients. The trial now can move to a second cohort. On the back of “encouraging” phase I DFU results, the company earlier said it would partner the program. Kelly said Cynata now would need to provide additional funding – but it’s not in a position to do this currently. Brooke said the board would update investors “quite soon”. As of the end of March, Cynata had cash of $1. 6 million and expects a $1. 2-1. 3m research and development tax incentive around October. Trial boost for RecceIn other trial news, ethics gatekeepers have green-lightedRecce Pharmaceuticals (ASX:RCE)to advance its local diabetic foot infection (DFI) study to pivotal phase III status. The study tests Recce’s synthetic antibiotic topical gel – R327G – as part of a two-pronged late-stage effort locally and in Indonesia. Both are registration studies under US Food and Drug Administration regulatory standards. “A pivotal phase III trial is considered a registrational study designed to generate the safety and efficacy data required to support regulatory approval applications,” Recce says. Human Research Ethics Committee (HREC) approval certainly hurries things along. “Given R327G’s excellent safety profile, the study has also been approved to include infected ulcers below the knee in addition to infected foot ulcers,” Recce says. “This will enable an additional primary endpoint analysis based on individual ulcers, increasing study power and enhancing the probability of success. ”Currently the local study has enrolled 18 patients, out of an expected 200. Recce will do an interim analysis when half the patients have been treated. The company expects full enrolment by the end of 2027. An earlier phase II study showed “strong efficacy”, achieving a 93% primary efficacy endpoint at day 14 and an 86% clinical response at day seven. DFI is a leading cause of hospitalisations and amputations among diabetics, causing “significant morbidity and reduced life expectancy”. Locally and in the US, DFIs account for more than 4400 and 130,000 lower extremity amputations, respectively. And here’s something else we didn’t know: Australia has the second highest amputation rate in the developed world. Woundcare newsWoundcare houseTetratherix (ASX:TTX)has raised $600,000 in a non-underwritten share purchase plan, having targeted up to $2 million. Earlier, the company raised $15 million in a placement. Both the placement and share plan were priced at $6 a share. Elsewhere in the woundcare sector,Avita Medical (ASX:AVH)has turned its attention to the UK, where besieged PM Keir Starmer certainly could do with a nice salve. Avita reports that in the first 17 uses of its Recell Go spray-on skin cells, all showed complete graft take-up in reconstructive surgery patients. The patients received Recell alone, or in combo with meshed split-thickness skin grafts. Investigators also reported uncomplicated donor-site healing and incident-free patient discharge. In random other news, shareholders in dental supplies exporterSDI (ASX:SDI)have approved a $166 million takeover proposal from a Chinese suitor, by a margin of 98% to 1%. We think the ayes have it. At Stockhead, we tell it as it is. While Cynata and Recce are Stockhead advertisers, the companies did not sponsor this piece.