Kodiak Sciences reports initiation of Phase 3 trial of KSI-301

Kodiak Sciences Inc. (KOD) reported the treatment of its first patients in three pivotal Phase 3 studies of KSI-301. These three randomized, double-masked studies are GLEAM, GLIMMER and BEACON. The study seeks to evaluate the impact of KSI-301 in treatment-naïve patients with diabetic macular edema and macular edema due to retinal vein occlusion. The former condition is being dealt with in GLEAM and GLIMMER trials, while the latter is the subject matter of BEACON.

The Phase 3 GLEAM and GLIMMER studies are global, multi-center, randomized trials. In each trial, patients are randomized to be administered either intravitreal KSI-301 or intravitreal aflibercept. KSI-301 will be given on an individualized dosing regimen every eight to 24 weeks after only three loading doses, while intravitreal aflibercept is administered every eight weeks after five loading doses in accordance with its label. It is expected that 450 patients will be enrolled in each of these studies.

The Phase 3 BEACON study is a global, multi-center, randomized study. In this trial, the patients will be randomized to be given intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. The stage will be followed by six months of each patients be given treatment on an individualized basis per protocol-specified criteria. The study is designed to enroll nearly 550 patients globally. The primary endpoint of this study is to measure and evaluate the change in best-corrected vision from the baseline at month six. The patients will be treated and monitored for one year.

The DAZZLE study is a Phase 2b/3 trial evaluating the drug candidate for treating treatment-naïve wet AMD. In this trial, patients are randomized to be given KSI-301 or aflibercept. It will enroll 550 patients, which will be treated and monitored for two years. Victor Perlroth of Kodiak said, “The randomization of treatment-naïve patients into these three pivotal studies in the third quarter is a critical step to build the clinical evidence for KSI-301 as a safe, effective and highly durable therapy for patients with retinal diseases.”

KSI-301 is an investigational anti-VEGF therapy and is intended to sustain potent and effective drug levels in ocular tissues for a longer time period than existing agents. Kodiak has developed this drug candidate by leveraging its Antibody Biopolymer Conjugate Platform. The company is mainly focused on developing treatments for retinal vascular diseases and damages caused by diabetic eye disease. The data from three mentioned studies will likely be used for forming the basis of the company’s initial BLA. The company has also planned an additional pivotal study in patients with non-proliferative diabetic retinopathy.

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Apart from KSI-301, Kodiak is also working on its bispecific anti-IL-6/VEGF biopolymer conjugate KSI-501 aimed at the treatment of neovascular retinal diseases with an inflammatory component.

Investment Thesis: The stock held itself well during the epidemic outbreak. The company has robust outlook with multiple studies going on. Any positive news on that front may give a further push to its stock price.

Incyte announces peptide-centric strategic collaboration with Nimble

Incyte Inc, (INCY) has inked a new collaboration with privately held Nimble Therapeutics Inc. The deal is related to the discovery of first-in-class peptide therapies across various disease segments. The companies intend to use Nimble’s proprietary peptide synthesis, screening and optimization platform for this purpose.

As per the terms and conditions of the collaboration, Nimble stands to gain an undisclosed upfront payment. It is also entitled to receive reimbursement of certain research program costs. Jigar Patel, Ph.D., CEO of Nimble Therapeutics, said, “This is an important collaboration for both companies to discover novel peptide-based therapeutics. We are excited to partner with Incyte, an organization with world-class drug discovery, development and commercialization capabilities, to ensure maximal patient impact across multiple disease indications.” Incyte will have an option to further augment the collaboration to incorporate additional targets.

Nimble Therapeutics focuses on parallel chemical synthesis approach towards drug discovery. Its proprietary technology is designed to facilitate the rapid synthesis, screening and engineering of scaffolded natural and modified macrocyclic peptidomimetics. The company has also developed a portfolio of biological assays for developing empirical screening and optimization of molecules with more favorable drug-like properties. Nimble is also working on engaging with leading pharmaceutical companies for leveraging its technologies in different segments.

Incyte will have exclusive rights for developing and commercializing any peptides developed under this collaboration. On the other hand, Nimble is entitled to receiving downstream milestone payments and royalties. Nimble will also bring to the table its expertise in chemical diversity and its integrated suite of assays. These capabilities are expected to help in faster discovery and optimization of high-potential compounds for intracellular and extracellular targets.

Investment Thesis: Incyte has strong fundamentals to back up its stock, which has shown smart recovery from its pandemic lows. It is currently trading at attractive valuations and has good catalysts coming up.

AMAG receives a setback as the FDA rejects Makena

AMAG Pharmaceuticals Inc. (AMAG) announced that the FDA has sent it a notice proposing the withdrawal approval of Makena. The drug candidate was approved for reducing preterm birth in pregnant women who have had a prior spontaneous preterm birth. The regulatory authority has also notified the company that it has the opportunity to request a hearing on the withdrawal.

At the current time, Makena’s approval and product label remains unchanged. The product continues to remain available to patients and prescribers. AMAG CEO Scott Myers said, “We disagree with the FDA’s proposal to withdraw Makena without having the opportunity to meet with them to discuss the generation of additional effectiveness data while preserving access for patients to the only FDA approved treatment option for indicated women.”

AMAG stated that it deems the entirety of clinical data on Makena to be sufficient to corroborate its continued positive benefit-risk profile. Currently, Makena and its generic equivalents are the only FDA-approved treatments available for pregnant women at risk for recurrent preterm birth. The main reason behind the FDA move is the lack of efficacy. Earlier, an FDA advisory group had voted 13-3 stating that clinical data submitted by the company did not adequately demonstrate substantial evidence of effectiveness.

AMAG is a commercial-stage biopharmaceutical company. It is mainly engaged in developing therapeutics for wide range of medical conditions. Apart from Makena, the company also has Feraheme in its product portfolio. It is indicated for treating iron deficiency anemia in a specific set of adult patients.

Investment Thesis: The FDA decision has come as an untimely blow for the company. However, AMAG has reaffirmed its Covis deal, making it an investment contender for investors with strong risk appetite.

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