• CoLucid Pharmaceuticals

  Participated · Series C · Jan 2015

  CoLucid Pharmaceuticals is developing oral lasmiditan for the acute treatment of migraine and an intravenous formulation for use by health care professionals. The company has completed six clinical studies, including a Phase 2b trial treating a single migraine attack in 391 patients and a TQTc study. It plans to use the new funding to advance its Phase 3 program, including the first pivotal study COL MIG-301 “SAMURAI,” for acute migraine treatment. CoLucid emphasizes addressing unmet needs for patients poorly served by current therapies, including those with cardiovascular risk factors who may be unable to take triptans. The company is led by CEO Thomas P. Mathers and is partnered with ILDONG Pharmaceutical under a distribution and supply agreement for lasmiditan in South Korea and Southeast Asia. CoLucid is based in Durham, North Carolina. CoLucid Pharmaceuticals is a privately held biopharmaceutical company based in Research Triangle Park, NC, focused on developing therapies for migraine and other CNS disorders. Its lead program is lasmiditan, a Neurally Acting Anti‑Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of therapies. The company also lists COL-204 for wake promotion and a conjugated stigmine platform that has generated preclinical candidates for chronic pain, Alzheimer’s disease and psychiatric disorders. CoLucid intends to use the financing to advance lasmiditan into Phase 3 development and into pivotal studies planned for 2012. It is interacting with the FDA and is engaged in discussions with potential partners. As of the article, CoLucid has raised $7.5M of a planned $9.5M convertible note financing.

• Aerpio Pharmaceuticals

  Participated · Equity · Apr 2014

  Aerpio Therapeutics is a clinical‑stage biopharmaceutical company focused on small‑molecule therapies that activate Tie2 and stabilize HIF‑1α. Its lead program, AKB‑9778, is a first‑in‑class Tie2 activator currently in a randomized Phase 2 trial for diabetic macular edema (DME). The Phase 2 study is testing AKB‑9778 as monotherapy and as an adjunct to ranibizumab with primary endpoints of change in visual acuity and central retinal thickness. Aerpio is also advancing AKB‑4924, a HIF1 activator, toward clinical development for inflammatory bowel disease after robust preclinical activity in models of ulcerative colitis and Crohn’s disease. Proceeds from the recent financing will support expanded development of AKB‑9778 and progression of AKB‑4924 into the clinic. The company announced the financing from Cincinnati and expects to initiate development in a second target indication before year end. Aerpio Therapeutics is focused on developing Tie2-activating small molecules, with lead candidate AKB-9778 targeting diabetic macular edema (DME). AKB-9778 inhibits human protein tyrosine phosphatase β (HPTPβ) to restore Tie2 signaling, stabilizing retinal blood vessels to reduce edema and vascular leak. A 28-day Phase 1b/2a ascending-dose study in 24 DME patients showed AKB-9778 was well tolerated and produced meaningful changes in retinal thickness and vision gain in some treated patients. The company plans an expanded clinical program, including a Phase 2 study to confirm monotherapy efficacy and to explore adjunctive use with a VEGF inhibitor; a Phase 2 was expected to begin early in 2014. Financially, Aerpio completed a $9 million extension to its $27 million Series A from 2012 to support ongoing development. The company announced corporate activity including investor participation and a board change tied to the financing. Aerpio Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies that stabilize vasculature via Tie2 activation and HIF-1α stabilization. The company's lead candidate, AKB-9778, is a first-in-class small molecule that inhibits HPTPβ to restore Tie2 signaling. AKB-9778 showed tolerability and on-target pharmacology in a Phase 1 healthy volunteer study and is entering a Phase 1b/2a trial for diabetic macular edema (DME). Aerpio plans a large, definitive Phase 2 study in DME patients following completion of the Phase 1b/2a study. The company cites potential utility of Tie2 activators in age-related macular degeneration and retinal vein occlusion but is currently focused on DME. Aerpio was created in a spin-out transaction from Akebia Therapeutics in December 2011 and is based in Cincinnati.

• Akebia Therapeutics

  Participated · Series C · Jun 2013

  Akebia Therapeutics is a fully integrated biopharmaceutical company focused on developing vadadustat, an investigational therapy for anemia in patients on dialysis. The company says vadadustat is under FDA review, with a potential decision noted for March 27, 2024. Akebia secured a $55 million term loan facility to strengthen liquidity around that regulatory milestone. The arrangement provides $37.0 million immediately and an additional $18.0 million contingent on FDA approval of vadadustat. The financing includes an extended interest-only period and deferred principal repayment, which reduces near-term cash outflows. Management frames the facility as enabling the company to navigate pre- and post-approval activities, including potential commercialization efforts. The deal increases financial leverage and creates eventual repayment obligations tied to the company’s future regulatory and commercial outcomes. Akebia Therapeutics is developing AKB-6548, an orally available hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor intended to treat anemias secondary to chronic kidney disease (CKD) and end‑stage renal disease. The compound is positioned as a potentially safer, orally dosed alternative to injectable erythropoiesis stimulating agents (ESAs) by stimulating endogenous EPO via HIF2α stabilization. In a 93‑patient, 42‑day Phase 2a CKD trial AKB-6548 produced a statistically significant, dose‑related increase in hemoglobin with a safety profile comparable to placebo and low iron requirements. Akebia plans a 140‑day Phase 2b CKD trial expected to begin in the third quarter and intends to use new financing over the next 18 months to complete studies and prepare AKB-6548 for Phase 3. The company was spun out of Procter & Gamble Pharmaceuticals in 2007 and is based in Cincinnati, Ohio. No revenue or user metrics were disclosed in the article. Akebia Therapeutics is a discovery and development company focused on treatments for chronic anemia. Its lead program, AKB-6548, is an orally bioavailable HIF-prolyl hydroxylase (HIF-PH) inhibitor currently in Phase 2 clinical trials. AKB-6548 is described as potentially best-in-class, offering potential advantages including an improved safety profile, once-daily oral dosing, and lower cost of goods versus traditional erythropoiesis stimulating agents. The company drew down a $4.1 million tranche of a previously announced Series B financing to enable completion of the Phase 2 study and to continue the process of selecting a partner for Phase 3 pivotal studies. The tranche was provided by a syndicate of life-science investors. Separately, Akebia spun out two programs—AKB-9778 (Tie-2 activator) and AKB-4924 (HIF-1α stabilizer)—to form a new stand-alone company, Aerpio Therapeutics. Akebia Therapeutics is a Cincinnati, OH–based pharmaceutical discovery and development company focused on anemia and vascular disorders. Its lead anemia program is AKB-6548, which the company says offers potential advantages over traditional erythropoiesis-stimulating agents, including an improved safety profile, oral dosing and lower cost of goods. The financing announced enables Akebia to complete two Phase 2b studies of AKB-6548 and to position that program for pivotal studies. Akebia also plans to advance AKB-9778, a novel Tie-2 activator for diabetic macular edema and vascular leak, into the clinic. The company closed a $22m Series B with a $14m first closing and the right to access an additional $8m through the end of 2011, which funds these near-term clinical plans. Akebia Therapeutics was formed by Joseph Gardner and John Rice to commercialize therapies acquired from Procter & Gamble and focuses on small-molecule drug discovery and development. Its lead candidate is AKB-6548, an oral erythropoietin-stimulating drug intended to treat chronic anemia. The company reported positive Phase 1 results in 33 healthy volunteers, showing increased erythropoietin and reticulocytes and good tolerability. Akebia plans to move into Phase 2 clinical trials for AKB-6548 and is evaluating partnering with a large pharmaceutical company or pursuing additional fundraising to complete development. Financially, the company recently completed a second closing that boosted a previously announced financing to $17 million. Management expects market opportunities due to safety concerns with existing injectable ESAs and potential expansion of the treated patient population if oral agents prove safer and easier to use.

• Tolera Therapeutics

  Participated · Series B · Oct 2012

  Tolera Therapeutics develops immunotherapeutics with a focus on the transplantation, autoimmune and oncology markets. Its lead clinical candidate is TOL101, a therapeutic monoclonal antibody intended for prevention of acute organ rejection. The company is preparing to advance TOL101 into Phase 3 clinical testing and plans to submit a Special Protocol Assessment (SPA) with the U.S. FDA. Tolera builds on research conducted at the University of Kentucky and the Cleveland Clinic. Led by CEO John Puisis, the company is commercializing its monoclonal antibody technology for the transplantation market. In October 2012 Tolera closed a financing round to fund its Phase 3 preparations.

• Juventas Therapeutics

  Led · Series B · Jul 2012

  Juventas Therapeutics is focused on developing non-viral gene therapies for advanced cardiovascular diseases, with its lead candidate JVS-100 undergoing evaluation in clinical studies. JVS-100 is being developed under an exclusive license from the Cleveland Clinic. The company was founded in 2007 and is based in Cleveland, Ohio, and is led by president and CEO Rahul Aras, Ph.D. Juventas recently expanded its Board of Directors with the addition of James Boland. Financially, the company secured a financing package comprising equity and debt to support its clinical-stage programs. The financing details indicate a mix of Series B-2 equity and debt with milestone-linked additional capital available. Juventas Therapeutics, founded in 2007 and led by President & CEO Rahul Aras, Ph.D., is a Cleveland, OH-based clinical-stage regenerative medicine company advancing JVS-100, its lead product encoding Stromal cell‑Derived Factor 1 (SDF‑1). JVS-100 has been shown to repair damaged tissue by recruiting circulating stem cells to sites of injury, preventing ongoing cell death, and restoring blood flow. The company closed a $22.2M Series B financing and intends to use the funds to complete ongoing Phase II clinical trials. The Phase II trials are investigating JVS-100 in patients with chronic heart failure and critical limb ischemia, and both trials are actively enrolling. The financing supports continued clinical development of the therapy and associated programs.

No current team members are available.