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Formation Bio said it plans to deploy new capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. Megarounds have been few and far between in 2024, but Formation Bio has managed to draw in an impressive $372 million series D as the AI-focused biotech seeks to expand its pipeline. AI companies like to promise the world, but Formation’s offering is more mundane. The idea is that Formation will partner with biotechs to improve their workflow automation—such as generating tailored patient recruitment content for specific cohorts of a clinical trial or speedily producing AI-generated adverse event reports. The ambition accelerates when the company looks ahead to the “medium term,” when it hopes to assemble a so-called “AI R&D Scientist” that can “provide drug development teams with decision support and eventually steer high-quality R&D decisions.” “In the long term, the company's goal is to build and train AI models that can better predict toxicity, tolerability, and one day, efficacy,” Formation explained in a June 26 release. The series D was led by a16z with “significant participation” from existing partner Sanofi—which has other AI-focused collaborations with partners including the likes of Owkin and Exscientia. Formation, which was formerly known as TrialSpark, said it plans to deploy this capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. The company currently lists three candidates in its clinical pipeline, including a SYK/JAK inhibitor called gusacitinib in phase 3 development for chronic hand eczema. There’s also a sodium channel blocker called ASN008 in phase 2 trials for notalgia paresthetica and itch associated with atopic dermatitis as well as an FGF18 drug called sprifermin in phase 2 for knee osteoarthritis. Both gusacitinib and ASN008 were bought from Asana BioSciences in 2022, while sprifermin was licensed from Merck KGaA. “By partnering with Formation Bio, smaller biotechs can advance more than just their lead asset, creating a pathway for other drugs in their pipeline,” the company said in the release. “For large pharma companies, Formation Bio creates an ‘off balance sheet’ pathway for development, enabling a company to take more shots on goal in a P&L efficient way.” Sanofi already announced a drug development partnership with both Formation and OpenAI last month. CEO Paul Hudson used a statement in this morning’s release to reemphasize that the French pharma is “all in on AI.” “We are proud to partner with and invest in Formation Bio, whose AI-driven drug development vision and capabilities will help lead our industry forward in the shared ambition to accelerate and improve how we bring more new medicines to patients,” Hudson added.

NEW YORK, May 23, 2023 /PRNewswire/ -- TrialSpark, Inc. announced today that the first patient has been dosed in its Phase 2 clinical trial for ASN008-201, a topical sodium channel blocker in development for pruritus associated with atopic dermatitis (AD). This clinical trial is a randomized, double-blind, vehicle-controlled, Phase 2 trial to evaluate the anti-pruritic efficacy, safety, tolerability, and pharmacokinetics of ASN008 in adults with mild to moderate AD (NCT05870865). Topline data for this trial is expected in 2024. Atopic dermatitis is a chronic inflammatory skin disease, and pruritus is the most burdensome and prevalent symptom in patients suffering from AD. Treating atopic itch, which impacts more than 16.5 million patients in the US, has historically been a challenge due to an incomplete understanding of the multiple mechanisms underlying its pathogenesis. "We are thrilled to have dosed our first patient in this clinical trial," said Gavin Corcoran, Chief Development Officer at TrialSpark. "Dermatology is a core focus area for our company, and there is enormous unmet patient need, so we're looking forward to progressing this clinical trial as efficiently as possible." This clinical trial will enroll approximately 120 participants at around 28 study sites across the United States. Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25%, ASN008 gel 2.5%, ASN008 gel 5%, or matching vehicle twice a day for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. "We are grateful to the patients who are participating in this clinical trial and to the healthcare professionals who are working with us to advance our research," said Benjamine Liu, TrialSpark CEO and Co-Founder. "Our company's mission is to bring new treatments to patients faster than ever before, and the contributions of patients, doctors, and sites are essential to achieving that goal." For more information about the clinical trial, please visit . About TrialSpark Founded in 2016, TrialSpark is a tech-driven pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, and cardiometabolic diseases. TrialSpark is actively growing its development pipeline. In November 2022, the company announced the formation of Libertas Bio following the acquisition of a majority position in a portfolio of immunodermatology assets from Asana BioSciences. The Libertas Bio pipeline includes ASN008, as well as global rights to gusacitinib, an oral Phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema. TrialSpark also announced the formation of Highline Bio following the acquisition of worldwide rights to sprifermin - a potential first-in-class disease modifying treatment for osteoarthritis - from Merck KGaA, Darmstadt, Germany. Media Contact: [email protected] BD/Partnerships Contact: [email protected] SOURCE TrialSpark