Immunodominant Announces Call for Initial Investment Round as Company Prepares for Phase 2 Study of Oral OTC COVID-19 Drug
Immunodominant Inc., a drug discovery and development company engaged in progressing innovative research from academia to commercialization, today announced its intention to begin an initial financing round of up to $30 million. Immunodominant also announced today that it is scheduling a Phase 2 clinical study after a pre-IND meeting with the FDA for LACTOVID, a novel, oral, over-the-counter drug for the prevention and treatment of COVID-19.
Immunodominant also announced today that it is scheduling a Phase 2 clinical study after a pre-investigational new drug application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for LACTOVID, a novel, oral, over-the-counter drug for the prevention and treatment of adults with COVID-19, including long COVID. This Phase 2 clinical study will evaluate the safety and efficacy of LACTOVID in this population.
LACTOVID is designed to be taken as one OTC product combining two compounds with direct antiviral activity against COVID-19 (through multiple mechanisms of action including binding to sigma receptors, binding to ACE2, blocking viral entry by neutralizing heparan sulphates, and by regulating inflammatory responses). Antiviral activity of LACTOVID has been observed in vitro (99% inhibition of SARS-CoV-2 replication) and in vivo (using ACE2 transgenic mice). The two active ingredients of LACTOVID have a long history of safety, with decades of clinical trials and human use as a generic OTC monograph drug and a dietary supplement classified as generally recognized as safe (GRAS) by the FDA.
“We are now at a point where we are seeking strategic partners that share our vision of combatting emerging threats and improving human health. We are enthusiastic to take this next step,” said David Ostrov, PhD, Immunodominant’s Founder, Chairman, and Chief Executive Officer; and member of the Global Virus Network’s COVID-19 Taskforce. “We focused our resources and expertise to work with regulatory authorities to establish that LACTOVID can be a safe and effective drug in the fight against COVID-19. The active ingredients of LACTOVID bind different proteins relevant to the SARS-CoV-2 life cycle. This makes it much more difficult for viruses to develop resistance. LACTOVID will be more accessible as an OTC product as the safety profile of its two well-known compounds have fewer side-effects and dangerous drug interactions compared to newer drugs, such as Paxlovid. An effective oral OTC product for the prevention and treatment of COVID-19 is expected to inhibit disease spread, inhibit progression of the disease, reduce the burden on national healthcare systems, and save lives on a global scale.”
“We anticipate a successful Phase 2 study for our IND application,” Dr. Ostrov continued. “Our in vitro research was confirmed in vivo with ACE2 transgenic mice, allowing us to estimate dosage levels in humans. Recent research also shows a positive benefit for COVID in patients using each of LACTOVID’s individual ingredients. Based on known mechanisms of action, we expect LACTOVID to inhibit all coronaviruses, including all SARS-CoV-2 variants of concern.”
“There is a large gap in the market for an OTC product for COVID,” said Marcus Kirk, PhD, Immunodominant’s Chief Financial Officer. “For example, Paxlovid is forecasted to deliver 120 million courses to global governments in 2022 at $530 per course of 30 pills. While Paxlovid has played an important role as part of the early COVID response, it is a prescription drug for treatment that must be taken at the onset of symptoms, has adverse side effects that include drug interactions, and led to COVID rebound from drug resistant SARS-CoV-2. We are aiming to be broadly available in the U.S. and international markets as an OTC product with fewer drug interactions, and for both the prevention and treatment of COVID, including long COVID symptoms. Prevention includes periods such as when traveling, in close contact with someone with COVID, and during a local surge.”
“We are delighted to reach a stage exploring a strategic collaboration and investment,” continued Dr. Kirk. “Earlier in the year prior to our pre-IND meeting, an independent calculation of value estimated our LACTOVID intellectual property at between $157 to $273 million. We are now approaching the point when, for example, Atea Pharmaceuticals completed over $200 million in Series D financing to start its Phase 2 study after the FDA cleared its IND application. We are seeking to raise up to $30 million to support the clinical development of LACTOVID including our upcoming Phase 2 study as part of our submissions to global regulatory agencies.”
David Ostrov, PhD, CEO and Chairman