Cerebral edema

• Trial results of a new drug to treat Alzheimer’s disease, donanemab, shows it can slow cognitive decline by 35%.
• And how might this drug affect the lives of people with Alzheimer’s disease?
• Read more:
  New Alzheimer’s drug: what you need to know about donanemab’s promising trial results

What is Alzheimer’s disease?

• The disease is caused by the accumulation of two proteins: amyloid and tau.
• Amyloid can accumulate for at least 20 years prior to the onset of symptoms, forming clumps in the brain.

What have drug treatments aimed to do?

• Multiple drugs targeting amyloid have, however, failed in clinical trials over most of that period, casting doubt on the validity of amyloid as a target – until recently.
• Donanemab is one of three monoclonal antibodies targeting amyloid that have shown various degrees of success in clinical trials in slowing decline in people with early stage disease.

OK so what did the donanemab trial find?

• The manufacturer’s clinical trial included 1,736 patients with very mild memory loss due to Alzheimer’s disease, and with early clinical Alzheimer’s disease.
• Half received donanemab by intravenous infusion over an 18-month study, the remainder were treated with a placebo (a “dummy” version).
• Those with low and intermediate tau declined by 35% less than those treated with placebo.
• About half of the treatment group cleared amyloid from their brains below the threshold used to diagnose the disease, over 12 months of treatment.

What are the downsides?

• Around one-quarter of the treatment group showed some degree of swelling, most of which didn’t cause symptoms.
• The cost of donanemab will be significant, at US$26,500 or around A$39,000 per year.
• Eli Lilly, the drug’s manufacturer, has applied to the Therapeutic Goods Administration (TGA) for approval for use in Australia.

Preparing for early detection and treatment

• The potential for early treatment means this needs to change.
• We also need to develop our diagnostic and treatment infrastructure (building the necessary PET scanners and infusion centres) that will be necessary to facilitate timely diagnosis and treatment when the drug does become available locally.

• The patent is groundbreaking because ANVS402 offers significant advantages over the previous, less structured form, including better stability, higher purity, and longer half-life, improving buntanetap’s effectiveness.
• The composition of matter patent is the single most important patent for any pharmaceutical company developing a new drug.
• Approval of this patent will come with protection of ANVS402 and all its uses for a 20-year patent term.
• “Annovis is extremely excited about the potential of ANVS402 and its future iterations in the treatment of neurodegenerative diseases,” said Michael Hoffman, chairman of Annovis.

• While most people suffer acute and relatively short-lived effects, such as dizziness and headache, in some cases symptoms persist for weeks, months or years.
• Concussion in sport – from the junior to the elite level – is being prioritised as a public health concern in Australia.
• The latest data show concussion can happen in nearly every sport, not just contact sports, with almost 3,100 hospitalisations for concussion caused by sports in 2020–21.

Traumatic brain injury

• Concussion is a form of traumatic brain injury that can result in neurological dysfunction, including migraine, cognitive deficit, confusion, slowed reaction times, personality changes, drowsiness and emotional changes.
• After brain injury there is a cascade of events that impacts the health of neurons and affects the flow of chemical ions, such as calcium, in the brain.
• Read more:
  Concussion: almost half of people still show signs of brain injury after six months

Other types of genes

• Apart from a role for ion channel genes, there have been a number of additional genes linked by research to concussion.
• Another genetic variation in the ApoE gene that makes it less productive has been linked to a higher likelihood of concussion.
• Beyond ApoE, genes that help control a variety of brain functions have been suggested as factors in concussion – including some involved in neuronal growth, dopamine receptors and, most recently, brain axon (nerve fibre) development.

A predisposition for injury

• Questions concerning the link between genetic predisposition to injury in sport are not new.
• In 2016, the Australian Institute of Sport (AIS) released a position statement on the ethics of genetic testing and research in sport.
• Athletes and support staff there are open to the idea of genetic information being used to improve sport performance and reduce injury risk.

What’s next?

• Before introducing genetic testing, regulatory and governance frameworks would also need careful consideration.
• She is a member of the Human Genetics Society of Australasia and Chair of the Board of Censors for Diagnostic Genomics.

• Ended the first quarter of 2023 with cash, cash equivalents and short-term investments of $116.1 million.
• Net product revenues were $2.1 million and cost of product revenues were $0.6 million for the first quarter of 2023.
• Research and development expenses were $2.1 million for the first quarter of 2023, compared to $4.3 million for the first quarter of 2022.
• As of March 31, 2023, scPharmaceuticals’ total shares outstanding was 35,769,073.
  scPharmaceuticals’ management will host a conference call and webcast to review the Company’s first quarter 2023 results today, Wednesday, May 10, at 4:30 p.m.