Ashvattha Therapeutics – a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation – announced additional financing as an extension of its Series B of up to $50 million led by Tribe Capital with existing investors led by Natural Capital. This funding will enable Ashvattha to complete the ongoing Phase 2 ophthalmology trial and Phase 1/2 neuroinflammation trial.
The Phase 2 study in wet AMD and DME subjects evaluates the novel, proprietary nanomedicine migaldendranib (MGB; D-4517.2), which is subcutaneously administered every 2 or 4 weeks for up to 40 weeks after a single intravitreal injection of aflibercept (2 mg).
For the subjects completing 24 weeks, there has been a substantial reduction in the need for supplemental aflibercept compared to 24 weeks before enrollment. The maintenance of visual acuity and sustained reductions in subretinal fluid have been observed to have an excellent safety profile. The interim results will be presented at the February 8, 2025, Angiogenesis meeting.
KEY QUOTES:
“We believe Ashvattha is a broad platform for HDTs to target and reprogram activated innate immune cells in the human body. These cells are implicated in inflammation, cancer, heart disease, aging disorders, autoimmune and neurological diseases. Built on over twenty years of work at Johns Hopkins, with four safety studies and three Phase 2a trials under the belt, we believe the platform of over one hundred HDTs has reached a point where we can see its impact on the human population in the next few years.”
– Arjun Sethi, Chief Investment Officer of Tribe Capital
“These interim results validate our novel approach of developing an at-home subcutaneous injection to treats both eyes in patients with bilateral disease from a single administration. Unlike all other clinical stage approaches, we have demonstrated a benefit to patients with bilateral disease with a well-tolerated systemic therapy. Over 40% of wet AMD and over 90% of DME subjects in our trial had bilateral disease that would require both eyes to receive injections of current products or clinical candidates. We look forward to sharing detailed results at upcoming medical conferences in 2025.”
– Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics
