ASX Health Stocks: Amplia’s pancreatic cancer trial gets boost; Emyria’s MDMA therapy is one step closer
Health & Biotech
Health & Biotech
Amplia Therapeutics (ASX:ATX) reported promising clinical data from its Phase 1B portion of the ACCENT trial in pancreatic cancer.
This trial, which studied the effect of Amplia’s narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel (Abraxane), has now been completed.
The trial was not powered for efficacy readouts, however initial activity signals, whilst preliminary, look to be very encouraging.
All 14 patients were assessed on what effect the drug treatment had on their cancer using the international standard Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Initial data obtained showed that a dose of Amplia’s narmafotinib was safe and well tolerated.
Around 36% of patients demonstrated a partial response as their best overall response, and with a disease control rate (combined partial response and stable disease) of 93%.
These numbers compare very favourably with the published data of the clinical benefit of the gemcitabine and Abraxane combination in pancreatic cancer.
All patients who completed their first 28-day cycle of treatment elected to stay on narmafotinib, with seven patients having received narmafotinib as part of the combination for five months or more.
As previously reported, one dose-limiting toxicity event was observed and notably, no treatment-related adverse events greater than Grade 3 were considered related to narmafotinib.
Upon these results, the study will now be taken into the Phase 2a portion of the trial that will start imminently.
“We have now identified a safe and well tolerated dose of narmafotinib to take into the Phase 2a stage of the trial, and the preliminary efficacy signals we have seen to date, across three dose cohorts, are very encouraging,” said Amplia CEO, Dr Chris Burns.
MDMA specialist Emyria (ASX:EMD) has secured an ethics endorsement for MDMA from its Authorised Prescriber (AP) application.
The National Health and Medical Research Council (NHMRC) ethics committee has endorsed Emyria in support of its AP applications for the lead psychiatrists of its future MDMA-assisted therapy program.
The approval is the first stage of a two-step evaluation, where final approval is still required from Australia’s Therapeutic Goods Administration (TGA) which is still in progress.
Following the TGA’s recent rescheduling of MDMA and psilocybin for PTSD and treatment-resistant depression respectively, the restrictions around their prescribing remain highly stringent due to the lack of “approved” or “registered” versions of these medicines.
Consequently, the medicines can only be accessed via clinical trials or from specialist psychiatrists who secure AP status from the TGA.
Following active dosing in Emyria’s ethics-approved trial, the AP endorsement, if secured, may allow Emyria to become one of the first Australian companies to offer broader options for PTSD patients with inadequate relief from conventional care.
Emyria’s CEO Dr Michael Winslo says the AP program provides new, but unapproved, options for patients who have exhausted standard care options.
“With our history of successfully securing over 16 AP approvals for our clinicians involved in our cannabinoid treatment programs, this ethics-committee endorsement further highlights our dedication to expanding care options for Australian patients,” he said.
Meanwhile, medication management platform provider, MedAdvisor (ASX:MDR), reported Q1 FY24 operating revenue of $25.4 million, up 27% on pcp.
The company attributes this result to growth and diversification of vaccine programs, as well as expansion in chronic medication programs.
Q1 gross profit was up 30.8% to $15.7 million, exhibiting an increase in gross profit margin of 1.8% to 61.8% on pcp.
MDR also ended the quarter with a strong cash position, with $9.8 million cash on hand as of 30 September.
“Despite the economic and operational changes affecting our customers in both the US and ANZ, we are witnessing a strong demand for our services as our customers rely on us to navigate these challenges effectively,” said CEO, Rick Ratliff.