FLXN: Flexion Therapeutics Analysis and Research Report

2018-02-19 - by Asif , Contributing Analyst - 50 views

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Flexion Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis, referred to as OA.

On October 6, 2017, the U.S Food and Drug Administration, or FDA, approved Zilretta, as the first and only extended-release, intra-articular, or IA (meaning in the joint), injection indicated for the management of OA related knee pain. Zilretta is a non-opioid therapy that employs its proprietary microsphere technology to provide pain relief for over 12 weeks. Zilretta is not intended for repeat administration, as the efficacy and safety of repeat administration of Zilretta have not been evaluated.

Flexion Therapeutics was incorporated in Delaware in November 2007, and to date Flexion Therapeutics has devoted substantially all of its resources to developing its product candidates, including conducting clinical trials with its product candidates, preparing for the commercialization of Zilretta, providing general and administrative support for these operations and protecting its intellectual property. As of September 30, 2017 Flexion Therapeutics has not yet generated any revenue from product sales. From its inception through September 30, 2017, Flexion Therapeutics has funded its operations primarily through the sale of its common stock, convertible preferred stock, convertible debt, and debt financing. From its inception through September 30, 2017, the company had raised approximately $624 million from such transactions, including from its initial and follow-on public offerings and the issuance of convertible notes. Until such time, if ever, as the company can generate substantial product revenue, the company expect to finance its cash needs through a combination of equity offerings, debt financings, government or third-party funding, and licensing or collaboration arrangements.

ZilrettaTM (triamcinolone acetonide extended-release injectable suspension)

Zilretta combines a commonly administered steroid, triamcinolone acetonide, or TA, with poly lactic-co-glycolic acid, referred to as PLGA, with the goal of delivering a 32 mg dose to provide extended therapeutic concentrations in the joint and persistent analgesic effect. Zilretta was designed to address the limitations of current IA therapies by providing extended, local analgesia. Both the magnitude and duration of pain relief provided by Zilretta in clinical trials have been shown to be clinically meaningful with the magnitude of pain relief amongst the largest seen to date in OA clinical trials.

The overall frequency of treatment-related adverse events in these trials was similar to those observed with placebo and no drug-related serious adverse events were reported. Based on the strength of its pivotal and other clinical trials, the company believe that Zilretta has the potential to address a significant unmet medical need for OA pain management by providing safe, effective and extended pain relief. The company believe Zilretta is uniquely distinguished by the following attributes:

  • significant pain relief at week 12 versus placebo (p-value of <0.0001, 2 sided) as measured by the weekly mean of the Average Daily Pain, or ADP;
  • durable and significant pain relief beginning at week 1 and continuing through week 12 with approximately 60% of patients reporting no pain or mild pain at week 12;
  • numeric improvements in validated OA specific measures compared to placebo and immediate-release TA injection;
  • an acceptable safety profile with side effect similar to placebo;
  • statistically significant (p<0.05, 2-sided) reduction in the rise of blood glucose compared to that observed following immediate-release TA injection in Type 2 diabetic patients who also have knee OA;
  • persistent concentrations of drug in the joint; and
  • reduced rescue medicine consumption compared with placebo and immediate-release TA injection.

Additionally, Flexion Therapeutics has fully enrolled more than 200 patients in an ongoing study to gather safety and exploratory efficacy data related to repeat administration. The company expect full data to be available in the third quarter of 2018 to inform both clinical and regulatory perspectives, and these data will form the basis for an interaction with the FDA. Furthermore, the company plan to initiate clinical trials of Zilretta in hip and shoulder OA and bilateral knee OA by the end of 2017.

Pipeline Program

FX101 – Intra-articular Therapy for the Treatment of OA Pain

FX101 (fluticasone extended-release) is a pre-clinical drug candidate that aims to provide extended pain relief for patients with OA. FX101 leverages its proprietary microsphere technology, and based on its pre-clinical, in vivo pharmacokinetic studies, the company believe it has the potential to provide patients with pain relief for up to six months. The company intend to conduct Good Laboratory Practice (GLP) toxicology studies, and pending successful results, the company will file an Investigational New Drug to advance FX101 into clinical trials.


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