Xanomeline Tartrate/Trospium Chloride

BOSTON--( BUSINESS WIRE )--Adams Clinical, LLC (“Adams”, or the “Company”), a leading Neuroscience-focused clinical trial site network announced today that it has agreed on terms of the intent to partner with InSite Clinical Research (“InSite”), a clinical trial site in the Dallas-Fort Worth metroplex with expertise in inpatient and outpatient clinical trials for psychiatric and neurologic illnesses, including Schizophrenia. In parallel with this partnership, Adams Clinical is expanding inpatient capabilities to its existing Watertown, MA and Bronx, NY sites. The Company expects both locations to begin screening inpatient participants in the first half of 2025, augmenting Adams’ market-leading capabilities in outpatient Psychiatry and Alzheimer’s Disease treatment and prevention trials. “InSite adds an important dimension to our business as it expands Adam’s disease area expertise and marks the Company’s entry into Texas,” said Nelson Rutrick, CEO of Adams Clinical. “Historically, Adams Clinical focused only on Depression, outpatient Psychiatry, and Alzheimer’s Disease. Dr. Shiwach and the entire InSite team are widely regarded by pharmaceutical and biotech industry sponsors as a leader in acute Schizophrenia, Bipolar Disorder and Substance Use Disorder research. Dr. Shiwach and InSite are well-known for their contributions in many successful clinical trials that have led to new drug approvals over the last 20 years.” Mehran Ahmed, Partner at InTandem Capital Partners, added, “InSite has developed a strong track record in finding participants in this growing therapeutic area and we are excited to partner with InSite to further enhance their capabilities.” “I am delighted to join the Adams Clinical network and bring opportunities for additional clinical trials to the diverse psychiatric and neurological patient population that we serve here in Texas,” said Dr. Raj Shiwach, Principal Investigator at InSite. “I look forward to sharing my clinical expertise to replicate our successful inpatient Schizophrenia trial delivery model in the Massachusetts and New York locations.” Dr. Steve Brannan, an industry veteran in Schizophrenia drug development who most recently led the clinical development and successful FDA submission of Cobenfy (xanomeline & trospium chloride, formerly known as KarXT) as Chief Medical Officer of Karuna Therapeutics, said, “Dr. Shiwach made a substantial enrollment contribution in our Phase 2 and 3 KarXT trials. There continues to be an enormous unmet need for effective new therapies for people living with Schizophrenia and other psychiatric illnesses. The many promising new treatments in development across industry will necessitate an increase in clinical research sites capable of conducting high-quality inpatient and outpatient Psychiatry trials for the foreseeable future. The acquisition of InSite and the establishment of inpatient units at the existing Boston and New York City locations underscores Adams Clinical’s strategic alignment with the needs and priorities of their pharmaceutical and biotech sponsor customers.” The partnership with InSite follows a series of strategic expansion steps Adams Clinical has undertaken in 2024, including doubling existing site capacity with the opening of new site locations in New York City with Davis Clinical in the Bronx and Berman Clinical in Harlem. Provident Healthcare Partners served as the exclusive financial advisor to InSite Clinical in this transaction. About Adams Clinical Adams Clinical is the preeminent site network for enrollment speed and data quality in clinical trials for diseases of the central nervous system, with clinical trial sites embedded in vibrant, diverse communities throughout the US. The Company’s depth of expertise, best-in-class technologies, and market-leading recruitment and retention to accelerate high-quality evidence generation and time-to-data for Pharmaceutical and Biotech companies, CROs and clinical trial participants. About InTandem Capital Partners InTandem Capital Partners is a private equity firm that invests in and helps accelerate the growth of select healthcare services companies. Its goal is to build excellent businesses of significant value working collaboratively with its management team partners. InTandem is solely focused on investing in businesses that align closely with the Healthcare Quintuple Aim – the simultaneous pursuit of enhanced patient experience, elevated provider experience, improved clinical outcomes, greater healthcare equity, and lower cost of care delivery. The firm is comprised of former business executives and experienced investors, and is uniquely qualified to provide strategic, acquisition and operating expertise to help companies significantly increase their value and their contribution to an improved healthcare system. InTandem provides active support to the management of its portfolio companies directly and leverages its network of industry executives to augment its capabilities. For further information, please visit: www.intandemcapital.com .

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . President-elect Donald Trump made good on his pledge to let Robert F. Kennedy Jr. “go wild on health,” nominating him as HHS secretary. For more on what this will mean for biopharma, read below, and keep checking back at Endpoints where our reporters will continue to have the latest. — Max Gelman RFK Jr. picked to lead HHS As Trump picked Robert F. Kennedy Jr. to be the next HHS secretary, Kennedy, a longtime anti-vaccine advocate, has said he will push for big changes at the FDA and NIH. At an event earlier this week, current FDA Commissioner Rob Califf weighed in on how the agency may be affected by the next administration, making pointed remarks about risks to its authority and workforce. When asked who might replace him, Califf said, “Hopefully it’ll be someone who understands the really critical role of high-quality evidence in everything we do.” AbbVie has a bad Monday The centerpiece of AbbVie’s $8.7 billion Cerevel buyout imploded on Monday, with the schizophrenia drug emraclidine registering not one, but two pivotal trial failures. Emraclidine had been expected to compete with Cobenfy , the newly approved drug from Bristol Myers Squibb and Karuna , but now it appears Cobenfy will have more of the market to itself. The news sent AbbVie’s stock down more than 12%, while BMS shares rose roughly 10%. Merck aims to keep Summit at arm’s length With Summit Therapeutics hot on its heels, the Keytruda developer spent $588 million upfront to get an exclusive global license to a PD-1/VEGF combination therapy called LM-299 , currently in Phase 1. The asset comes from LaNova Medicines , a startup based in Shanghai that can receive up to $2.7 billion in biobucks from the deal. Merck is attempting to stay in front of Summit and Akeso’s ivonescimab , which beat Keytruda in a Phase 3 lung cancer study earlier this year. 23andMe shuts down therapeutics division DNA testing company 23andMe announced this week that it’s closing its therapeutics division and winding down ongoing clinical trials. It’s also cutting 40% of its workforce or more than 200 employees. The move is the latest in a string of setbacks for 23andMe, including a data breach last year that affected millions of customers. The company said it’s exploring a range of options for offloading its therapeutic programs, including licensing agreements, asset sales or other deals. Aurion and its investor Alcon enter legal battle Cell therapy startup Aurion and its investor Alcon are engaged in an unusual legal spat after Alcon sued the biotech as it prepares to go public. While Alcon claimed its shareholder rights were being violated, Aurion argued in a counterclaim that Alcon “opposes the IPO because it interferes with Alcon’s plans to acquire Aurion at a discount.” The stakes are high for Aurion, which said its cash runway only extends to March, putting urgency on its plan to go public in January. SPOTLIGHT MORE IN R&D MORE IN PHARMA MORE IN FDA+ MORE IN STARTUPS MORE IN PEOPLE MORE IN MANUFACTURING MORE IN HEALTH TECH