Terran Biosciences

Thank you, Andrea Corona from Pharma Manufacturing, for spotlighting the advancements and challenges across the schizophrenia treatment landscape. Terran’s TerXT, is our novel combination of xanomeline and trospium prodrugs, designed to enable a once-daily oral formulation and a multi-month long-acting injectable formulation.   With TerXT we are committed to pursuing accelerated regulatory pathways to provide accessible, effective, and affordable treatments to patients. Read the full article here: https://lnkd.in/ghQKktUt #schizophrenia #mentalhealth

Had a great time speaking with Moira Gunn on the #BioTechNation podcast about our new schizophrenia drug TerXT and our other CNS pipeline assets including the antipsychotic idazoxan XR, psychedelics, and novel non-hallucinogenic psychoplastogens.

We’re thrilled to share a recent feature in Bloomberg News by Christopher Yasiejko that spotlights Terran’s groundbreaking work in developing therapeutics and technologies for people with neuropsychiatric illnesses. Chris delves into Terran’s approach to improving and optimizing therapies, including TerXT, a novel combination of prodrugs of xanomeline and trospium for the treatment of schizophrenia. For TerXT, and several other pipeline products, Terran plans to pursue the accelerated FDA 505(b)(2) pathway, which may enable Terran to use pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to bring Terran’s products to market approximately five years after their approval. The article outlines how Terran’s innovative drug design efforts, regulatory strategy, and approach to IP could set the tone for a more accessible, patient-friendly era in neuropsychiatric drug development. Read the article here: https://bit.ly/3VPDV9u #Schizophrenia #DrugDevelopment #DrugDesign

Enjoyed speaking with Harsh Thakkar on Life Sciences 360 podcast, where I cover recent developments in the mental health space, including our new drug for schizophrenia, TerXT, in development here at Terran Biosciences. See below to watch/listen:

In this BioSpace article I share my thoughts on the recent FDA Adcomm vote for Lykos Therapeutics’ #MDMA assisted therapy for #PTSD. Thanks Gail Dutton for the discussion.

In this recent op-ed published in the Miami Herald, Terran CEO and Founder Sam Clark, MD PhD, outlines the need for a greater focus on making novel psychedelic therapies accessible to the patients who need them. The FDA's recent granting of breakthrough therapy designation to several psychedelic-based therapies has laid the groundwork for a new era in mental health treatment. However, because the hallucinogenic effects of these drugs necessitate physician-supervised administration and monitoring, the cost of treatment is likely to limit coverage and, in turn, patient access. As one of many companies contributing to Miami’s growing psychedelic drug development landscape, Terran has worked to circumvent these limitations through the development of novel, non-hallucinogenic therapeutic compounds. To learn more about Terran’s approach to making accessible and affordable psychedelic-based mental health therapeutics a reality, read Dr. Clark’s article here: https://lnkd.in/gquc6Dxe #MentalHealth #Psychedelics #Accessibility #DrugDevelopment

The FDA isn’t slated to render a decision about Bristol Myers Squibb and Karuna Therapeutics' potential breakthrough #schizophrenia med KarXT until September — but Terran Biosciences is already hoping to be hot on its heels. “This is not a new formulation of #KarXT, this is an entirely new drug — a prodrug of xanomeline and trospium,” Sam Clark, MD PhD, Terran’s founder and CEO, told PharmaVoice. https://lnkd.in/gUJHkSe6

In this The Medicine Maker article, Sam Clark, MD PhD, and other biotech leaders share their insights on R&D for Alzheimer’s disease (AD). The experts discuss the successes and setbacks of AD treatment prospects, recent promising innovations, and their predictions for the future of AD treatment. Terran is excited to be pressing forward with therapeutics and technologies that could benefit patients with AD.   “I envision a future where AD is more similar to a treatable cancer than the slow, devastating, and inevitable decline that patients face today. Between innovations in the diagnosis of AD pathology and in the development of treatments that effectively target the mechanisms driving the disease, it is not implausible to believe we can reach this point.” - Sam Clark, MD, PhD   Read the full article here: https://lnkd.in/gJbAGXvf #Alzheimersdisease #Alzheimers

I recently had a conversation with Molly Rose Campbell and Sarah Whelan from Technology Networks about the future of psychedelic therapeutics and my thoughts on the recent adcomm vote against the approval of MDMA for PTSD Despite the relatively safe nature of many psychedelic compounds, for the last 50 years, they have been classified as Schedule I controlled substances and labeled as “not accepted for medical use” with a “high potential for abuse.” I talked about this stigma and other persistent challenges these therapeutics encounter in clinical settings (e.g. as seen with Lykos’ recent studies of MDMA for PTSD), as well as my hope for these therapies to become accessible and affordable options for patients in need.   You can listen to and read the full interview here:
https://lnkd.in/ewTjxruF #pyschedelictherapy #MDMA #PTSD

In this Drug Topics interview, Terran’s CEO and Founder Sam Clark, MD PhD, shares his thoughts on the Psychopharmacologic Drugs Advisory Committee voting against the FDA approval of Lykos Therapeutics’ MDMA treatment for post-traumatic stress disorder. With the crucial need for more affordable and accessible therapies, Dr. Clark discusses the potentially harmful impact this decision could have on the psychedelic-based treatment landscape for neuropsychiatric conditions. https://lnkd.in/ehb4-gJp #PTSD