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- Ophirex has secured FDA agreement to develop varespladib for snakebite treatment under the Animal Rule pathway, which permits human approval using animal efficacy data and human safety data. - The oral snakebite treatment has received FDA MUMS designation for dogs and multiple human designations including Orphan Drug, Rare Pediatric Disease, and Fast Track status. - Two completed Phase 2 studies showed mixed results, with the primary endpoint not met in BRAVO but signals of benefit observed in patients treated within five hours of bite. - The company is targeting a global health crisis affecting 4-5 million people annually, with 75% of snakebite deaths occurring before hospital arrival.
- BiomEdit raised $18.4 million in Series B funding led by Anterra Capital to advance its designer probiotics platform for animal health applications. - The company's lead candidate BE-101 (Optavant) represents the first probiotic vectored antibody product designed to prevent necrotic enteritis mortality in broiler chickens. - BE-101 has entered the final phase of USDA conditional licensure process with commercial launch targeted for late 2026, addressing an estimated $6 billion annual industry loss. - The platform leverages synthetic biology to engineer microbes that express targeted antibodies against Clostridium perfringens toxins, offering a novel approach to poultry disease prevention.
- Neurizon Therapeutics (formerly PharmAust) is repurposing monepantel, an existing animal drug, for the treatment of motor neuron disease (MND). - Monepantel inhibits the mTOR signaling pathway and stimulates autophagy, potentially slowing MND progression and increasing life expectancy. - The company's monepantel will be evaluated in the Healey ALS platform trial across 70+ US sites, potentially accelerating approval. - Preliminary Phase I data showed monepantel could slow MND progression by up to 58% and increase life expectancy by as much as 56.5 months.
