ASX Health Stocks: Neuren stock price up 100pc on positive Phase 3 results
Health & Biotech
Health & Biotech
The ASX 200 Health Index (XHJ) is down by 0.80% at the time of writing, compared to the broader index which is down by 0.40%.
The stock price of Neuren Pharmaceuticals (ASX:NEU) is up 100% this morning after the company announced its North American partner, Acadia Pharma (Nasdaq: ACAD) reported positive top-line results from the Phase 3 Lavender study of trofinetide.
The study evaluated trofinetide in 187 girls and young women aged 5-20 years with Rett syndrome, a serious neurological disorder that emerges in early childhood.
Acadia said that trofinetide has met co-primary efficacy endpoints, demonstrating statistically significant improvement over placebo.
These results are significant because Neuren has the potential to earn material revenues (up to $111m over 2022 and 2023) for its Rett syndrome treatment in the US alone, plus double-digit percentage royalties on net sales, if a New Drug Application is approved by the FDA.
Acadia plans a Pre-New Drug Application meeting with the FDA in Q1 2022, and New Drug Application (NDA) around mid-year 2022.
“We are delighted with these robustly positive results, and are now eager to see trofinetide progress through the regulatory approval process,” commented Neuren CEO Jon Pilcher.
Recce Pharma (ASX:RCE) says that clinicians have reported visible reductions in bacterial infection within the first 24 hours of R327 treatment among patients treated to date.
R327 is Recce’s lead compound used to treat patients with serious burn wound infections.
The drug is currently undergoing a Phase I/II clinical trial at the Fiona Stanley Hospital in WA.
The study has shown that when using R327, patients’ burn wound infections cleared within 5 days for acute cases, or 7 days for chronic cases.
The study is on-going, with target patient enrolment and treatment expected early 2022, allowing full data-set reporting to follow.
Actinogen Medical (ASX:ACW) has announced strategic collaboration with Oxford University researchers to investigate Xanamem and a condition called Mild Autonomous Cortisol Secretion (MACS).
MACS is associated with over-production of the stress hormone cortisol by non-cancerous growths on the adrenal glands.
Actinogen will supply the Xanamem drug to Oxford free- of-charge, as well as providing trial design support.
“The MACS collaboration represents an important opportunity to investigate the potential benefits of Xanamem on the cortisol system outside of the brain,” said Actinogen’s CEO, Dr Steve Gourlay.
Final results are anticipated in 2024.
Starpharma Holdings (ASX:SPL) has signed an exploratory DEP Research Agreement with Genentech, a member of the Roche Group.
The initial focus of the collaboration will be on evaluating DEP (dendrimer based) drug conjugates.
Starpharma’s proprietary dendrimer-based DEP platform has broad commercial applicability in drug delivery, including reductions in certain toxicities such as bone marrow toxicity.
The company has three Phase 2 clinical stage DEP assets, multiple preclinical DEP programs, and has applied its DEP technology in partnership with pharmaceutical companies for many different applications.
Imugene (ASX:IMU) announced that City of Hope, its research partner in California, has commenced dosing the second patient in the Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc.
Imugene is working with City of Hope, a world-renowned independent cancer research and treatment centre based in LA, in a clinical study of CHECKvacc.
CHECKvacc is a human Phase I Study of CF33-hNIS-antiPDL1, a potential compound used to treat patients with advanced or metastatic breast cancer.