KVD001 / KalVista - LARVOL DELTA

"We gave an oral presentation today on our oral investigational candidate KVD001 at ACS #ACSFall2021" (@KalVista)

Discovery of KVD001: A potent and selective small-molecule plasma kallikrein inhibitor for the treatment of diabetic macular edema (ACS-Fall 2021) - "Ocular pharmacokinetic studies in monkey following intravitreal dosing of KVD001 demonstrated a long half-life in ocular tissues and retina (and choroid) levels confirmed the compound was able to reach the posterior ocular tissues. KVD001 is a potentially first-in-class PKa inhibitor for the treatment of diabetic macular edema which has undergone a phase 2 clinical study."

Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

One-Time Intravitreal Injection of KVD001, a Plasma Kallikrein Inhibitor, in Patients with Central-Involved Diabetic Macular Edema and Reduced Vision: An Open-Label Phase 1B Study. (PubMed, Ophthalmol Retina) - No abstract available

Clinical • Journal • P1 data • Diabetic Macular Edema • Ophthalmology

KalVista Pharmaceuticals provides update on diabetic macular edema programs (Businesswire) - "KalVista Pharmaceuticals...today announced that the option agreement between KalVista and Merck related to intravitreal diabetic macular edema (DME) candidate KVD001 and future oral DME molecules has expired....With the option expiration, KalVista has no obligations to Merck, and retains full ownership of all of its DME intellectual property..."

Licensing / partnership

Investigational plasma kallikrein inhibitors for the treatment of diabetic macular edema: an expert assessment. (PubMed, Expert Opin Investig Drugs) - "We also shed light on KVD001 which is furthest along the development pathway, THR-149 which has recently completed a phase 1 study and oral agents under development.Expert Opinion: Plasma kallikrein inhibitors have a potential role in the treatment of DME, with mixed functional/anatomic results in early clinical trials. Given the large unmet need in DME treatment, further studies are warranted."

Journal

KVD001 protects DME patients from losing their vision, phase 2 trial shows (angioedemanews) - P2, N=129; NCT03466099; Sponsor: KalVista Pharmaceuticals, Ltd.; "'This trial studied a challenging DME patient population with significant persistent vision loss despite prior therapies,' Lloyd Paul Aiello, MD, PhD...said in a press release."

Media quote • P2 data

KalVista’s eye drug for diabetic macular edema flunks mid-stage trial (BioSpace) - P2, N=129; NCT03466099; Sponsor: KalVista Pharmaceuticals, Ltd.; "'This trial studied a challenging DME patient population with significant persistent vision loss despite prior therapies,' said Lloyd Paul Aiello...'These study data support the possibility that plasma kallikrein inhibition prevents worsening vision in patients with DME and that KVD001 warrants additional study in this regard as a method to treat this disease.'"

Media quote • P2 data

KalVista Pharmaceuticals reports phase 2 clinical trial results in patients with diabetic macular edema (Businesswire) - P2, N=129; NCT03466099; Sponsor: KalVista Pharmaceuticals; "KalVista Pharmaceuticals...today announced results of the Phase 2 clinical trial evaluating the use of KVD001 in patients with diabetic macular edema...Although the study did not meet the primary endpoint, KVD001 demonstrated what we believe is an important dose responsive clinical benefit on vision in the overall population. In addition, we identified a substantial proportion of patients who experienced a more robust response to treatment, that we believe warrants further study. These data and the safety profile also support continued evaluation of oral plasma kallikrein inhibitors as a treatment for DME..."

P2 data

KalVista Pharmaceuticals reports fiscal second quarter results (Businesswire) - "KalVista Pharmaceuticals...today provided an operational update and released financial results for the fiscal second quarter ended October 31, 2019...The Phase 2 clinical trial of KVD001 in DME will provide data this month..."

P2 data

KalVista Pharmaceuticals provides business update (Businesswire) - "KalVista Pharmaceuticals...today provided an update on the status of its development programs. KalVista now expects to complete enrollment for the KVD900 Phase 2 clinical trial before year-end 2019 and to provide data in 2020. The Phase 2 clinical trial of KVD001 in DME is still expected to provide data this quarter."

Enrollment status • P2 data

Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) (clinicaltrials.gov) - P2a; N=129; Completed; Sponsor: KalVista Pharmaceuticals, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion

KalVista Pharmaceuticals reports fiscal first quarter results (Businesswire) - "KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected in Q4 2019...Research and development expenses were $9.7 million for the three months ended July 31, 2019, compared to $8.4 million for the same period in 2018...These increases in expense were somewhat offset by a decrease in expense related to KVD001 as it heads toward completion of a Phase 2 clinical trial later this year."

Commercial • P2a data • Trial status

KalVista Pharmaceuticals: Our verdict (SeekingAlpha) - "...KalVista initiated a Phase 2 trial in 2018 that is evaluating ~123 patients who have discontinued anti-VEGF treatment and still present significant edema and reduced visual acuity....A data readout is expected in 2H19."

P2a data

KalVista Pharmaceuticals provides operational update and fiscal year financial results (Businesswire) - "Research and development expenses were $11.1 million for the three months ended April 30, 2019, compared to $5.9 million for the same period in the prior year. Research and development expenses were $35.0 million for the fiscal year ended April 30, 2019, compared to $18.2 million in the prior fiscal year. The increase in spending primarily reflects increased costs related to the ongoing clinical trial for KVD001..."

Commercial

Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) (clinicaltrials.gov) - P2a; N=123; Active, not recruiting; Sponsor: KalVista Pharmaceuticals, Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

KalVista Pharmaceuticals reports fiscal third quarter results (Businesswire) - "Intravitreal Diabetic Macular Edema (DME) Candidate KVD001 Phase 2 Trial Completion Expected H2 2019...Research and development expenses were $7.7 million for the three months ended January 31, 2019, compared to $4.5 million for the same period in 2018. The increase in R&D expense primarily reflects the ongoing clinical trials for KVD001..."

Commercial • Trial completion date