Keeping tabs on pharma: First precision medicine for autism spectrum disorders

Positive results for first precision medicine for autism spectrum disorders

Stalicla, a Swiss biopharmaceutical company, has successfully completed its initial round of clinical trials for what would be the first precision medicine to address autism spectrum disorders.

Stalicla develops precision medicines for patients with neurodevelopmental disorders (NDDs), particularly autism spectrum disorder (ASD).

Its Phase 1b studies showed that its lead drug candidate STP1 had positive results in clinical markers of neurological and behavioral function, including improved processing speed.

Commenting on the results, Dr Craig Erickson, lead investigator on the research at Cincinnati Children’s Hospital, said: “The electrophysiological signals from this study are remarkable and represent the strongest early trial target engagement signals our lab has seen in the autism field.

He added: “The findings from this project de-risk future larger-scale studies, given the personalized approach employed to biologically identify specific autistic individuals who may best respond to a treatment prior to study enrolment.”

The company is currently raising series B funding of US$65m to conduct further trials and to research its second precision drug candidate STP2.

AstraZeneca's preventative Covid-19 shot approved in Europe

AstraZeneca's preventative Covid-19 injection Evusheld has been approved for use in Europe. The Evusheld antibody treatment has been developed for adults who cannot receive conventional vaccines, either due to a weakened immune system or because they have a history of severe reactions to vaccinations.

Evusheld is a combination of two long-acting monoclonal antibodies (tixagevimab and cilgavimab) and is the only Covid-19 antibody treatment delivered as an intramuscular dose. It was approved for use in the UK earlier in March 2022 and was granted approval in the US in December 2021.

Myron J. Levin, MD, Professor of Pediatrics and Medicine at the University of Colorado School of Medicine, was a principal investigator on clinical trials for Evusheld in the US.

Commenting on the treatment, he said: “Millions of people in the US and around the world remain at serious risk for Covid-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer patients Evusheld as an easily administered new option that provides long-lasting protection that could help them return to their everyday lives.”

Cost of essential medication soars in India

The cost of more than 800 essential medicines will increase considerably in India after 1 April.

The National Pharmaceutical Pricing Authority of India (NPPA) has announced a 10.7 percent rise in the price of essential medicines, which include common painkillers, antibiotics, cardiac medication and anti-infection medicine. This is the first time the NPPA has granted a price hike this large on essential drugs - typically the cost has risen between one and two percent year-on-year.  

The industry has attributed the increase to the growing cost of raw materials and active pharmaceutical ingredients (APIs), which have experienced severe disruptions to supply due to the Covid-19 pandemic.

Also in the news:

• AstraZeneca is partnering with digital healthcare firm Huma Therapeutics on decentralized clinical trials. The two organizations are launching Software as a Medical Device (SaMD) companion apps with the aim of improving patient engagement in trials.
• The British Museum is removing the name of the Sackler family from its galleries after the family-owned company Purdue Pharma admitted misleading the American public about the addiction risk of OxyContin.
• Pharma IQ is hosting SimCare this week (March 29–30), [BM4] a virtual conference presented by Ansys about the power of computer modelling and simulation in drug development. Speakers from Pfizer, Amgen, Boston Scientific, Dr Reddy's Laboratories, Bayer and more will be sharing their insights on the in-silico approach. Find out more and register for free by visiting SimCare.

Quick links:

• Driving diversity in clinical trials
• How DtP can improve the success rate of clinical trials
• Too hard to handle? The challenges of handling and delivering highly potent oncology drugs

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