• Nasdaq-listed Biogen says its experimental Alzheimer’s drug study was successful
  • The news sends ASX-listed Cogstate to soar
  • Orthocell could have the first FDA-approved injectable cell therapy in orthopaedics 

Big news out of Nasdaq-listed Biogen (NASDAQ: BIIB) last night as the biotech said that its experimental Alzheimer’s drug with Japan-based partner Eisai showed promising results.

In the Phase 3 study, Biogen’s lead drug lecanemab was shown to remove built-up plaque in the brain called beta amyloid, which researchers say would lead to a cognitive benefit for patients with early-stage Alzheimer’s.

Biogen claims that the study demonstrated a high statistically significant reduction in clinical decline associated with the disease.

The study’s primary endpoint was Clinical Dementia Rating-Sum of Boxes or CDR-SB, which is a numerical scale that measures the severity of symptoms of dementia.

The study met this primary endpoint by showing that treatment with lecanemab in the early stages of the disease reduced the rate of clinical decline on the CDR-SB scale by 27% compared to placebo.

Analysts have lauded the latest results to be a new dawn for Alzheimer’s treatment.

Biogen’s stock price surged 40% on the news, which also also led to a 36% rally in the price of Cosgate (ASX:CGS) on Wednesday before the company put itself on a trading halt at 10.30am.

While Cogstate is not part of the study, the company had entered into an agreement with Eisai in 2020 to grant Eisai rights to exclusively develop and distribute Cogstate’s digital cognitive assessment technologies in worldwide markets.

Such digital cognitive assessments will play an important role in supporting the types of large-scale cognitive assessment that will be necessary in the launch of disease modifying therapies such as Biogen’s lecanemab drug.


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Orthocell’s orthopaedic therapy could become FDA’s first

Results from the rotator cuff clinical study showed that Orthocell (ASX:OCC)’s OrthoATI was more effective than corticosteroid injection for treatment of rotator cuff tendinopathy with intrasubstance tendon tear.

Patients randomised to receive a corticosteroid injection had the option to “crossover” to the OrthoATI treatment if there was a lack of response in the corticosteroid arm of the study.

82% of participants in the corticosteroid arm elected to crossover to OrthoATI, and experienced almost complete resolution of pain 6 months post-treatment, which was sustained at 12 months.

Orthocell says that OrthoATI is well positioned to become the first FDA-approved injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.


GSS’ Detection Kit could play big role in AMR infection

Genetic Signatures (ASX:GSS)’s EasyScreen Detection Kit for Antimicrobial Resistance (AMR) is shown to have excellent sensitivity and specificity by an independently conducted study.

The authors of the study conclude that the kit’s “short turnaround time and simplicity makes it suitable for routine use in most clinical microbiology laboratories”.

AMR is considered one of the leading public healthcare threats by the World Health Organisation, and is associated with over 5 million death per year worldwide or around 10 deaths every minute.

“This recent study further highlights the important role our kit could have in the early detection of AMR infections, both from a performance perspective and from its ease of use,” said John Melki, CEO of GSS.


GTG publishes a paper in respected Journal

Genetic Technologies (ASX:GTG) announced the recent publication of a paper in the Journal of Precision Medicine authored by GTG science team members, Dr Erika Spaeth, Director of Clinical Affairs, Dr Richard Allman, Chief Scientific Officer, and Dr Gillian Dite, Senior Biostatistician.

The paper, titled “Integrating Personalised Medicine into Preventative Care through Risk Stratification”, outlines how GTG’s geneType suite of risk assessment tools could result in a net improvement in stratification over traditional risk assessments.

Thee geneType Risk Assessment Test for breast cancer showed a 9-fold improvement in identifying at-risk women when compared with traditional gold-standard (IBISv7), 22.4% of women compared to 2.5% over the actionable threshold respectively.


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