Non-opioid drug developer snags PhIII funds; aTyr and Spruce line up capital

09 Feb 2023
endpts.com
Phase 2Phase 3Fast TrackIPO
A biotech looking to create a non-opioid back pain med has reeled in more financing. Spine BioPharma put together a $13 million convertible note from insiders that will eventually close into a Series C, CEO Marc Viscogliosi told Endpoints News . That represents the same size as the biotech’s Series B from last spring. Investors include the CEO’s firm Viscogliosi Bros, Pacira Biosciences and Cercano Management, the investment firm of the late-Paul Allen, co-founder of Microsoft. The drug developer expects to complete a Phase III trial of its one-time injected non-opioid candidate later this year or early next year, with data slated for a mid-to-late 2024 readout, the CEO said. Spine expects to enroll 400 patients with lumbar degenerative disc disease in the placebo-controlled US trial of SB-01, according to the federal trials database. Viscogliosi said back pain is the number two reason for opioid prescriptions in the US, as the country deals with an epidemic of overdose deaths and the biopharma industry struggles to bring non-opioid options to fruition. The goal is to inhibit TGFβ, and if the drug is successful at shrinking the concentrations of that cytokine in the discs, then the thinking is inflammation will be tampered and pain modulated, Viscogliosi explained. In earlier-stage trials conducted by the original developers in Korea, EnsolBio and Yuhan Corporation, Viscogliosi said a majority of patients had a 15-point improvement at six months on a 50-point pain-related disability score known as the Oswestry Disability Index. The index is also the primary outcome being measured in the ongoing Phase III, he said. San Diego biotech aTyr Pharma looks to raise $50 million via a public offering of more than 22 million shares. The proceeds from the offering, expected to close on Feb. 13, will go toward the drug developer’s lead candidate, efzofitimod, which is in a Phase III trial in pulmonary sarcoidosis in the US and Japan. Partner Kyorin Pharmaceutical recently began the Japan portion of the global late-stage study, which means aTyr picked up $10 million . The funds will also help bankroll a planned Phase II study of the NRP2 agonist in patients with systemic sclerosis-associated interstitial lung disease, for which the drug has fast track designation at the FDA. That study is expected to begin this year, the biotech said. The stock price sank more than 7% in early morning trading to about $2.20 per share $LIFE . Spruce Biosciences will get $53.6 million via a private placement to finance late-stage development of tildacerfont for endocrine disorders, the biotech said Thursday morning. The proceeds will bring its runway into the first half of 2025, which means enough for two Phase IIb data readouts, CEO Javier Szwarcberg said in a statement. That includes taking the CRF1 receptor antagonist through CAHmelia-203 this year, with topline data in the second half of this year, and finishing up the second trial CAHmelia-204 , with high-level results in the second half of next year. Taking part in the securities purchase agreement are 5am Ventures, Abingworth, Armistice Capital, HealthCap, Novo Holdings, RiverVest Venture Partners and Rock Springs Capital. Shares $SPRB were up more than 5% to about $3.34 apiece after the opening bell but are well below the $32 peak shortly after Spruce’s 2020 IPO .
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