Editors' (re)View: A new obesity startup; Schizophrenia treatment happenings

April 19, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of April 15.

Can a secret startup disrupt the obesity market?

Pharma news is buzzing about the new obesity startup, Metsera, which emerged from stealth mode yesterday, officially announcing its launch into the exploding sector.

With a global market projected to hit $100 billion in sales by 2030, and the market's two main players unable to come close to meeting supply demands, the sector is ripe for disruption.

Founded by biotech VC firm ARCH Venture Partners and private equity firm Population Health Partners, Metsera has a star-studded pharma cast, including Clive Meanwell, ex-CEO of The Medicines Company; Ian Read, ex-CEO of Pfizer; and John Maraganore, ex-CEO of Alnylam.

With its most advanced candidates in phase 1, Metsera's pipeline includes "next-gen" oral and injectable incretin, non-incretin and combination therapies designed to address multiple targets and meet the future needs of the weight loss treatment landscape.

The new company's purpose is to reduce the physical, emotional and economic burdens of obesity at a scale that keeps pace with the massive scale of the obesity problem — no easy feat. Metsera plans to address the needs that current treatments don't meet, such as effective weight maintenance, preserving muscle, less frequent dosing, and better efficacy, tolerability and patient access.

It's a tall order to fill but the company is coming at it from all angles. Metsera has already picked up a proprietary library of gut hormone peptides through an acquisition of London-based ZiHipp last year and has licensed several assets from Korea's D&D Pharmatech, including a peptide oral technology, an oral GLP-1/GIP dual agonist and oral amylin agonist.

While Metsera is certainly not without competition, the company's dedicated focus on obesity and its diversity in treatment options, combined with lessons learned from first-gen players, might be the secret recipe for success. —Karen Langhauser

Schizophrenia treatment happenings

Schizophrenia is a chronic and severe mental health disorder that affects approximately 24 million people worldwide, according to estimates by the World Health Organization.

Initially, schizophrenia treatments were mostly ineffective and often inhumane including practices such as lobotomies and electroconvulsive therapy without proper anesthesia. Based on the limited understanding of the disorder, these methods primarily focused on sedating patients. But the discovery of chlorpromazine in the 1950s marked a before and after, introducing the first  antipsychotic medications that could manage symptoms like delusions and hallucinations, drastically improving patient outcomes and quality of life.

Despite this, from the late 1950s to the 1980s, schizophrenia drugs saw limited progress following the debut of first-generation antipsychotics, which, despite their efficacy, often caused severe side effects. Research primarily aimed to refine these drugs to enhance safety and effectiveness. Another significant breakthrough occurred in the late 1980s with the introduction of second-generation antipsychotics, which offered fewer motor side effects and treated a broader range of symptoms, revitalizing the approach to managing schizophrenia.

Fast forward to earlier this week: Neumora Therapeutics announced that its phase 1 trial of NMRA-266 has been placed on hold after the discovery of convulsions in preclinical studies involving rabbits. Neumora reported that no similar issues have been observed among the approximately 30 human subjects who have received the drug, which targets the M4 muscarinic receptor.

While disappointing, the trial and other activity in schizophrenia research and development point to a renewed focus on finding more effective and targeted treatment alternatives.

Recently, Bristol Myers Squibb's KarXT showed continued symptom improvements in the phase 3 EMERGENT-4 trial, as presented at the Schizophrenia International Research Society Annual Congress. The trial's interim analysis indicated significant enhancement in schizophrenia symptoms at 52 weeks, involving 110 patients, 29 of whom completed a year of treatment. Over 75% of participants experienced a more than 30% symptom improvement, with an average reduction of 33.3 points on the Positive and Negative Syndrome Scale. KarXT targets M1/M4 muscarinic receptors and avoids traditional dopamine and serotonin pathways, marking a novel approach in schizophrenia treatment. The drug has a PDUFA decision date of September 26, 2024.

While the journey has included significant strides as well as challenges, it is encouraging to see more drugmakers committed to addressing the complexities of treating this disorder. — Andrea Corona

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor