Biogen-Eisai’s potential Aduhelm sequel drug secured speedy review by FDA

Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process.

The drug is the next in line behind the pair’s approved therapy Aduhelm, which secured a yes under the agency’s accelerated review pathway back in June. The decision has proven controversial for Biogen, which has struggled to launch the drug and lately decreased the price to half to catch up on boosting sales.

However, Biogen and Eisai have requested the FDA for a similarly accelerated review of lecanemab. Their submission got underway in September on a rolling basis, with the companies sending information to the agency as it comes in.

Their application is based on biomarker and safety data from a phase 2b trial in patients with early Alzheimer’s disease – Biogen said the drug could decrease amyloid plaques in the brain and lessen cognitive decline. These plaques are a hallmark of Alzheimer’s, and the current thinking is that lowering them can reduce the neurodegeneration process.

The FDA previously set a precedent with Aduhelm by approving it based on similar biomarker data showing the decrease in plaques. Biogen and Eisai have said the drug is likely to impede the underlying cause of the disease. Still, Aduhelm has not yet been proven effective in decreasing the debilitating symptoms of Alzheimer’s. 

Quidel acquires Ortho Clinical Diagnostics in USD 6 Billion deal

Quidel has heavily benefited from COVID-19-related revenues over the past nearly two years of the pandemic, creating a massive cash windfall. Nevertheless, the manufacturer of the point-of-care diagnostic, which makes various coronavirus tests, suffers long-term growth concerns with the unavoidable dwindle in testing needs.

During last month’s third-quarter earnings call, Bryant said that while Quidel hopes there will be a persistent need for COVID-19 rapid antigen testing for at least the next few quarters.

Quidel plans to access new and emerging markets by tapping Ortho’s global reach as one of the world’s largest pure-play in vitro diagnostics companies and combining complementary portfolios spanning high-throughput systems to near-patient and at-home testing.

Bryant in a statement, said the Quidel-Ortho combination aims to come as a global player with top-tier R&D capabilities, a more diverse product pipeline, and broader geographic footprint.

Quidel also made a case for revenue and operating synergies due to the Ortho acquisition, saying it anticipates strong cross-selling revenue synergies over USD 100 million by 2025.

Besides developing the world’s first tests for the antibodies detection against HIV and hepatitis C, Ortho claimed to have secured the first emergency use authorizations from FDA for mass-scale antigen, antibody, quantitative antibody, as well as nucleocapsid and spike antibody tests.

FDA approves IND application of Accutar for a prostate cancer treatment trial

The US Food and Drug Administration (FDA) has given the green light to Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for metastatic castration-resistant prostate cancer (mCRPC) treatment.

An investigational orally bioavailable, chimeric degrader molecule, AC0176 is designed to aim and degrade androgen receptor (AR) for prostate cancer treatment.

AR is a hormone-regulated transcription factor, which plays a vital role in the initiation and progression of prostate cancer.

Accutar stated that AC0176 showed selective and robust degradation of AR protein with broad coverage of AR mutants and favourable pharmacological properties in the preclinical studies.

In the Phase 1 study, AC0176’s pharmacokinetics, preliminary anti-tumour activity, safety, and tolerability will be evaluated for treatment of mCRPC patients.

Accutar Biotechnology CEO Jie Fan said that the IND clearance for AC0176 is another vital validation, after their AC0682 entered the clinic lately, that their AI platform can support and progress the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders.

The IND clearance for AC0176 is also critical towards delivering a potential new treatment for prostate cancer based on a differentiated mechanism of action from second-generation nonsteroidal AR antagonists, which are the current standard of care for this patient population.

The company anticipates to initiate enrolment of participants for the Phase I clinical trial in the first quarter of next year.

Boehringer’s spesolimab improves flare signs in Phase II GPP trial

Boehringer Ingelheim has shown that its experimental therapy, spesolimab, substantially enhanced signs and symptoms of flare in generalised pustular psoriasis (GPP) patients in Phase II Effisayil 1 clinical trial.

A humanised, selective antibody, spesolimab impedes interleukin-36 receptor (IL-36R) activation. IL-36R is a signalling pathway within the immune system associated with several autoimmune ailment pathogenesis, such as GPP.

The 12-week trial enrolled 53 subjects with a GPP flare, who were randomised into a 2:1 ratio to get one 900mg spesolimab intravenously or placebo. A GPP Physician Global Assessment (GPPGA) pustulation subscore of 0 indicating no visible pustules at the first week was the trial’s primary goal.

The GPPGA score of 0/1 signifying clear/almost clear skin at week one was the key secondary goal of the trial. Findings hinted that 54% of subjects in the spesolimab arm had no visible pustules versus 6% in the placebo arm, meeting the primary endpoint.

Furthermore, 43% of subjects who received spesolimab termed had clear/almost clear skin as against 11% of subjects treated with placebo. Continued pustular and skin clearance were observed during the course of the trial with clinically significant enhancement in quality of life and symptoms comprising pain and fatigue reported in the treatment arm versus placebo.