ANA Therapeutics

Founded in 2020 by Akash Bakshi, Andrew Bartynski, and Nadja Mannowetz, ANA Therapeutics was a biopharmaceutical firm created specifically to address the COVID-19 pandemic. The founding team pivoted from their work at Y Combinator on a contraceptive gel after discovering that the drug niclosamide, which they were exploring for its antiviral properties against STDs, showed promise as a treatment for coronaviruses like SARS and MERS in earlier studies. This realization prompted the formation of ANA Therapeutics to repurpose niclosamide for COVID-19.

The company's core focus was the development of ANA-001, a proprietary oral capsule formulation of niclosamide designed to treat patients with moderate to severe COVID-19 who did not require ventilators. Niclosamide, a drug used for over 50 years to treat tapeworm infections, was identified as a candidate due to its potential to inhibit SARS-CoV-2 replication and its anti-inflammatory properties. The company's unique formulation was engineered to ensure the drug could enter the bloodstream at levels sufficient to be effective against the virus, a key modification from its original design which targeted the gut.

ANA Therapeutics operated on a milestone-based business model, centered on advancing ANA-001 through the FDA's rigorous clinical trial process. The company successfully raised over $5 million in a seed round from notable investors including Sam Altman, SOSV, and SV Angel to fund these trials. In August 2020, the FDA cleared its application to begin human clinical trials, a significant achievement that positioned ANA as a first-mover in testing niclosamide for COVID-19 in the U.S. The clinical program was a multicenter, two-part Phase 2/3 trial designed to evaluate the safety and efficacy of ANA-001.

In a strategic move to accelerate development, ANA Therapeutics was acquired by NeuroBo Pharmaceuticals (Nasdaq: NRBO) on December 31, 2020. The acquisition integrated ANA as a wholly-owned subsidiary, with its key executives, including CEO Akash Bakshi, joining the NeuroBo management team. The deal structure involved an initial issuance of NeuroBo stock with provisions for additional payments based on development and sales milestones. However, by June 2023, NeuroBo announced the discontinuation of the ANA-001 clinical development due to a significant reduction in the severity of COVID-19 cases and related recruitment difficulties.

Keywords: drug repurposing, niclosamide, COVID-19 treatment, antiviral, biopharmaceutical, clinical trials, FDA approval, NeuroBo Pharmaceuticals, oral formulation, Y Combinator