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CMO 360

A CMO’s Perspective on Designing Clinical Trials for a Psychedelic-Derived Drug Candidate

From a trial design perspective, we’ve tried to make these trials as familiar to stakeholders – regulators, prescribers, payors – as possible. What’s remarkable here are the qualities of the drug that we’re developing, MM120, a pharmaceutical formulation of LSD; we don’t need to do anything inconsistent with the history of psychiatric clinical trials beyond that.

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Data show sustained benefits of deucrictibant for HAE attacks

Pharvaris is moving forward with Phase 3 clinical trials. The RAPIDe-3 study (NCT06343779) is testing an immediate-release formulation of deucrictibant, called PHVS416, as an on-demand therapy for HAE. Recruitment is ongoing at sites in the U.S., Puerto Rico, South Korea, and Germany.

’1104: tackling the root cause of allergic disease

Revolo Biotherapeutics’ CEO, Woody Bryan, discusses how ‘1104, the Company’s lead candidate for allergic diseases, shifts the immune system from a pro-inflammatory state to a homeostatic state, offering potential remission for allergic conditions.

Recce Pharmaceuticals Advances Antibiotic Development to Combat Antimicrobial Resistance

At the World AMR Congress, Recce Pharmaceuticals contributes by making strides with a synthetic compound designed to target bacterial mutations, underscoring the need for innovation in addressing antimicrobial resistance (AMR). “Our compound is entirely synthetic,” Graham said. “We started with first principles, designing a compound that remains effective with repeated use.”

Combatting disease with antibody drug conjugates

This conversation features Dr Philipp Spycher, CSO and co-founder at Araris Biotech, and Dr Rebecca Boohaker, Director of Oncology at Southern Research.

Midtown biotech sells $75M to the public to show FDA the promise of psychedelics

Biotech company MindMed is shoring up its cash stockpile to inch its psychedelic therapies towards approval after the feds’ recent thumbs-down of using MDMA to treat post-traumatic stress disorder.

World-first MND drug trial offers hope to those living with the disorder

Spinogenix founder Dr Stella Sarraf joined Sky News Business Editor Ross Greenwood to discuss the ongoing groundbreaking trial.

Phase 2 Trial Evaluating LUM-201 for Treatment of Growth Hormone Deficiency

Pisit “Duke” Pitukcheewanont, MD, Chief Medical Officer for Lumos Pharma, discusses a phase 2 trial evaluating LUM-201 (ibutamoren) for treatment of growth hormone deficiency.