Aerpio Obtains $27M In Series A To Fund Pair Of Phase II Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
The recently spun-out company raised money to fund two Phase II trials in hopes of garnering a partner for its diabetic macular edema drug.
Aerpio Therapeutics recently closed a Series A financing that will carry it through 2014 and two mid-stage trials for its lead compound, AKB-9778. The company has spent the first nine months of its existence testing the drug in healthy volunteers and hopes that data from the upcoming trials will make the drug attractive to a partner.
The Cincinnati-based biotech was spun out of Akebia Therapeutics Inc. in December 2011 – five years after Akebia was spun out of Procter & Gamble Co. The two biotechs are run as virtual companies by a staff of former big pharma executives, but are focused on largely different types of therapies (Also see "P&G Spinout Spins Off Another Company, While Looking To Partner Mid-Stage Oral Anemia Candidate" - Pink Sheet, 21 May, 2012.).
Until now, Aerpio has been operating on the proceeds of a bridge financing. The Series A, which was announced Aug. 30, brought in $27 million for the company. It was led by Novartis BioVentures and joined by Venture Investors LLC, Triathlon Medical Ventures, Kearny Venture Partners, Athenian Venture Partners and AgeChem Venture Fund LP. All the investors had invested previously in Akebia. Joseph Gardner, CEO of both Akebia and Aerpio, said the syndicate of investors was comfortable working with the management of Aerpio after five years of working with Akebia.
The money will be used to fund a Phase Ib/IIa trial of AKB-9778, a Tie-2 activator that works by inhibiting human protein tyrosine phosphatase beta, an enzyme which counteracts vascular leakage to restore Tie-2 signaling. The 28-day dose-escalation study will begin in September and will test the safety and tolerability of ‘9778 in 30 patients with diabetic macular edema. Gardner said the company also is hoping to see strong signs of efficacy including decreases in retinal thickness and improvements in visual acuity. Results from that study are expected next spring.
Once the Phase Ib/IIa study has been concluded, the remainder of the funds raised will be used to fund a second Phase II study with 100 patients “that will get the attention of partners and make future financings a bit easier in this dry funding environment,” said Gardner in an interview. Results from this trial are expected in 2014.
"The activation of Tie2 by AKB-9778 has demonstrated promising activity in multiple models of retinal disease characterized by edema and neovascularization. Based on these findings, we believe that AKB-9778 could play an important role in the treatment of DME and potentially age-related macular degeneration and retinal vein occlusion,” he said.
DME is a disease characterized by leakage of blood proteins into tissues behind the macula of the eye, causing a thickening of that tissue. DME is the leading cause of vision loss in diabetics. More than 40% of diabetics develop some stage of diabetic retinopathy during the course of their disease. Roche/Genentech Inc.’s Lucentis (ranibizumab) recently was approved for the treatment of DME, but Gardner counters that Lucentis is both inconvenient and does not provide strong efficacy in this indication (Also see "Genentech Says Lucentis DME Product Will Ship Shortly" - Pink Sheet, 10 Aug, 2012.).
Lucentis is given as a once-monthly ocular injection. AKB-9778 likely will be administered by the patient through a once-daily subcutaneous injection. “We think a patient-administered therapy that fits into their current treatment paradigm could make a meaningful difference,” said Gardner.
Also in Aerpio’s portfolio is AKB-4924, a preclinical inhibitor of hypoxia-inducible factor-prolyl hydroxylase (HIF-PH). In preclinical studies in inflammatory bowel disease, ‘4924 has shown ability to protect and restore epithelial barrier function in the lower gastrointestinal tract. Aerpio plans to file an IND by the end of the year if further funding becomes available. The drug currently is being funded by money from grants and is not a priority for the company.